Stremler Research - Baby asleep with parent holding its hand.

Research Overview

Dr. Stremler’s research is aimed at improving health for families with healthy, typically developing infants and children, families whose child is experiencing acute or chronic illness, and families during pregnancy, labour and birth and the postpartum. For all families, sleep is a crucial component of overall health, and sleep disturbance has multiple effects on physical well-being, emotional resilience and cognitive performance. Exploratory, descriptive studies are conducted to characterize sleep quantity and quality for families in order to facilitate development of multi-modal behavioural-educational interventions to improve sleep. Interventions to improve sleep have potential for major public health impact. Please read below for details of on-going and completed studies as well as projects for which Dr. Stremler is a co-investigator.

Sleep for pregnant women and families with a newborn

Sleep TYME (Throughout Your Motherhood Experience) Study
TIPS (Tips for Infant and Parent Sleep) Trial
TIPS (Tips for Infant and Parent Sleep) Pilot

Sleep for families with an acutely or chronically ill child

Hospital Practices for Parents Sleeping Overnight
Sleep for Parents in Hospital Study
Kidzzz: Sleep for Kids in Hospital Study
Nurses Views on Providing Care at Night in Hospital
Sleep and Acute Lymphoblastic Leukemia (ALL) Study
SHARI (Sleep Hygiene And Relaxation Intervention) for children with ALL

Nursing interventions to improve perinatal outcomes for women and infants

LPT (Labour Position Trial) 2

LPT (Labour Position Trial)


Projects as a co-investigator

Better Nights/Better Days: improving psychosocial health outcomes in children with behavioural insomnia: CIHR Sleep and Circadian Rhythms Team Grant
Team Research and Training Program: CIHR Sleep and Circadian Rhythms Team Grant
Cues and Care Trial
Cues and Care Trial Follow Up
Enhancing Comfort of Children in the PICU Study
An RCT of Three SIM Learning Conditions for BScN Students’ Pain Education
Efficacy of Deteriorating Patient-based Simulation for Improving Pain Knowledge
Identifying Factors Involved in the Prenatal Diagnosis of Congenital Heart Defects
SELAN (Structured Early Labour Assessment and Care by Nurses) Trial
PLACE (Pregnant and Laboring in an Ambient Clinical Environment) Pilot Trial
Sleep and Fatigue in Children with Juvenile Idiopathic Arthritis



Sleep TYME (Throughout Your Motherhood Experience) Study

Principal Investigator: R. Stremler
Co-Investigators: D. Brown, C. Dennis, E. Hodnett, K. Lee, C. Morin, B. Murray, E. Pullenayegum, C. Ryan, R. Windrim
Funding:
CIHR

Little research has examined women’s experiences of sleep loss and sleep disturbance, particularly in pregnancy. During pregnancy, women are at particular risk of sleep disturbance due to physiological and anatomical changes, and yet they and their infants are at great need of the benefits of sleep. Sleep complaints are common in pregnancy; sleep duration for childbearing women reaches its lowest levels in the third trimester. Evidence suggests that the prevalence of some sleep disorders (e.g. sleep disordered breathing, restless legs syndrome [RLS], insomnia) is higher in pregnancy, but we know little of the development of, or factors related to, these sleep problems across the trimesters. Given that chronic sleep deprivation in other populations has negative effects on cardiovascular, metabolic, and mental health, it is not surprising that there is also some evidence that sleep disturbance in pregnancy increases the risk of adverse perinatal outcomes such as preeclampsia, caesarean section and depression. However, existing studies of sleep in pregnancy typically have small samples, focus on only one type of sleep disturbance or adverse outcome, and are cross-sectional in design.

OBJECTIVES: The Sleep TYME Study will: 1) determine the prevalence of three common sources of sleep disturbance, RLS, insomnia symptoms, and sleep-disordered breathing symptoms, in pregnancy and the early postpartum; 2) identify factors associated with sleep disturbance during pregnancy and the early postpartum; 3) describe patterns of sleep quality and quantity, sleepiness and fatigue in pregnancy and the early postpartum; 4) determine if sleep disturbance (RLS, insomnia, SDB, sleep <6 hours) is associated with adverse perinatal outcomes; 5) establish a cohort of women to be followed beyond the immediate postpartum to determine the resolution and natural history of sleep disturbance across women’s lives.

DESIGN: A prospective cohort of 665 women will be surveyed by telephone at four timepoints: between 16 and 20 weeks, 28 weeks, and 36 weeks gestational age (GA) and at 4 weeks postpartum. INCLUSION CRITERIA: Nulliparous women with a singleton pregnancy who are <20 GA. EXCLUSION CRITERIA: Women who: have experienced recurrent miscarriage at <20 weeks GA or a stillbirth or perinatal death at >20 weeks GA; have a condition known to affect sleep (e.g. seizure disorder); are unable to understand English; have no telephone in the home.

PROCEDURES: Research assistants will telephone women to conduct surveys at all timepoints. Surveys will determine: 1) prevalence of sleep disturbance using validated instruments (e.g. sleep quality, self-reported sleep time, apnea symptoms, RLS symptoms, sleepiness, insomnia); 2) factors associated with sleep disturbance including demographic factors (e.g. age, education, race), lifestyle factors (e.g. smoking, work hours, physical activity); and pregnancy symptoms (e.g. nausea, nasal congestion, reflux); and 3) adverse perinatal outcomes related to cardiovascular and metabolic health (e.g. gestational diabetes, hypertension, preeclampsia), mental health (e.g. depression, anxiety); infant health (e.g. operative delivery, Apgar scores); and social costs (e.g. work absenteeism, unintentional injury).

The Sleep TYME Study will provide better understanding of the prevalence of and risk factors for sleep disturbance in pregnancy. Only with this information can the development of prevention and screening strategies occur. Insight into the relationships between sleep problems in pregnancy and adverse outcomes will guide the development of interventions to improve sleep in pregnancy. Given the potential magnitude of the impact of sleep disturbance on perinatal outcomes, this work is essential for the health of Canadian families.

Data collection for this study is ongoing.

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THE TIPS (Tips for Infant and Parent Sleep) TRIAL

Principal Investigator: R. Stremler
Co-Investigators: E. Hodnett, K. Lee, J. MacFarlane, S. Weiss, A. Willan
Funding:
CIHR

Sleep disturbance and fatigue in the first few months after the birth of a child are major health concerns for postpartum women and infants.The results of previously published studies indicated that behavioral-educational strategies promote infant sleep, but these studies relied on parental report and did not include maternal sleep.

OBJECTIVES: The primary objective was to examine the effect of a behavioural-educational sleep intervention in the early postpartum on maternal nocturnal sleep. Additional objectives were to examine the effects of a behavioural-educational sleep intervention in the early postpartum on: length of an infants’longest nocturnal sleep period, maternal nighttime awakenings, infant nighttime awakenings, maternal sleep disturbance, depressive symptomatology, maternal morning fatigue, and breastfeeding.

DESIGN: Two-centre randomized controlled trial with stratification by centre. We enrolled and randomized 246 women to the experimental group or control group.

INTERVENTION: While in-hospital postpartum, women in the experimental group had a 45-minute discussion with a nurse about mother and baby sleep issues and strategies to improve both. A 20-page booklet containing the information discussed with the nurse was also provided. Support was also provided during 3 phone calls in the first 6 weeks. Participants in the usual care group received no information or support related to improving maternal and infant sleep. They met briefly with a research assistant while in-hospital and received 3 phone calls at home but no information or support for promotion of maternal or infant sleep were given. Infant and maternal sleep were measured using actigraphy and other outcomes were collected by maternal questionnaire at 6- and 12-weeks postpartum.

Data collection for this RCT is complete. Data analysis is currently underway.

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THE TIPS (Tips for Infant and Parent Sleep) PILOT RANDOMIZED CONTROLLED TRIAL

Principal Investigator: R. Stremler
Co-Investigators: E. Hodnett, K. Lee, A. Willan
Funding: SickKids Internal Funding

This pilot study of a maternal-infant sleep intervention evaluated feasibility, acceptability, and effects on sleep and other outcomes in the early postpartum period.

DESIGN: Randomized controlled trial with concealed-group allocation. First-time mothers were randomly assigned to sleep intervention (n = 15) or control group (n = 15).

MEASUREMENT AND RESULTS: Questionnaires were completed at baseline and 6 weeks; sleep diaries and mother and infant actigraphy were completed at 6 weeks. The mothers in the sleep intervention group averaged 57 minutes more nighttime sleep, and fewer rated their sleep as a problem, as compared with the mothers in the control group. Infants in the sleep intervention group had fewer nighttime awakenings and had maximum lengths of nighttime sleep that were, on average, 46 minutes longer than those in the control group.

This pilot trial is complete and has been published. For a link to the abstract, click here .


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HOSPITAL PRACTICES FOR PARENTS SLEEPING OVERNIGHT

Principal Investigator: R. Stremler
Co-Investigator: C. Parshuram

This study examined practices affecting parents' overnight stays, provisions for parents sleeping overnight, and parents' involvement in overnight care of their hospitalized child. Telephone surveys of 135 Canadian and American hospitals were conducted. It was concluded that parents are generally given the opportunity to stay at the bedside overnight, but barriers exist that limit opportunities for sleep during their child's hospitalization, and serve to separate families who have a hospitalized child.

This study is complete and has been published. For a link to the abstract, click here .

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SLEEP FOR PARENTS IN HOSPITAL STUDY

Principal Investigator: R. Stremler
Co-Investigator: C. Parshuram
Funding: Connaught Start Up Fund

Given the shift in pediatric hospitals towards family-centered care, many parents spend the night with their hospitalized child. Many health care professionals believe that parents’ sleep is affected by their child’s hospitalization, yet no studies have examined sleep for parents using objective determinations of sleep outcomes.

OBJECTIVES: To describe, for parents of critically ill hospitalized children, sleep quantity and quality, sleepiness and fatigue, barriers to sleep, and psychological outcomes. PARTICIPANTS: 118 parents of 91 children <18 years old with expected PICU stay>2 nights were enrolled.

PROCEDURES: For five days and nights, parents wore an actigraph to objectively measure sleep and kept a sleep diary which included a fatigue scale and sleepiness scale. After the final night, parents completed a questionnaire which examined several psychological outcomes and perceived barriers to sleep.

The quantitative portion of this study is currently being written up for publication.
For a link to the abstract of the qualitative portion of this study, click here.


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THE KIDZZZ SLEEP STUDY:
SLEEP DISTURBANCE IN HOSPITALIZED CHILDREN

Principal Investigator: R. Stremler
Co-Invesitgators: S. Adams, C. Parshuram, S. Weiss
Funding: Connaught New Staff Matching Fund & Sleep Research Society Foundation

Children who are hospitalized are attempting to sleep in a new environment primarily focused on patient care rather than child sleep. Many health care professionals believe that children’s sleep is seriously affected by their hospitalization, yet no studies have examined sleep for children in hospital using objective determinations of sleep outcomes.

OBJECTIVES: To examine, for hospitalized children, sleep quantity, sleep patterns, and barriers to sleep.

PARTICIPANTS: 69 children ages 12 months to 18 years were enrolled from a general medical unit (n = 58) or a critical care unit (n = 11).

PROCEDURES: For three days and nights, children wore an actigraph to objectively measure sleep, and light and sound meters were placed at the bedside. Children or parents completed a sleep diary which assessed morning pain scores and characteristics of the sleep environment (type of unit, type of room, parental presence, type of interruptions).

This study is currently being written up for publication.

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NURSES’ VIEWS ON PROVIDING CARE TO FAMILIES AT NIGHT

Principal Investigator: R. Stremler
Co-Investigators: S. Adams, K. Dryden-Palmer
Funding: Rosenstadt Research Fund

Children who are hospitalized and their parents who stay with them overnight are attempting to sleep in a new environment primarily focused on patient care rather than sleep. This environment is characterized by high levels of light and noise and frequent interruptions from health care providers. Conflict may exist around family desire to remain uninterrupted at night, and health care provider concern for patient safety and professional accountability.

OBJECTIVE: To elicit nurses’ views on providing care at night and perceived effects on sleep for the hospitalized child and parent.

PROCEDURES: Focus groups will be used to obtain participant opinions and views. Two focus groups will be held on a critical care unit and a general pediatrics unit for a total of four focus groups, each consisting of 4 – 10 nurses. The discussion will be recorded by audiotaping and later will be transcribed. An interview guide will be used to elicit participants’ views on providing care at night. Questions will address feelings and experiences, including expectations of parental involvement in care at night, patient safety concerns, attempts to minimize sleep disturbance, perceived barriers and facilitators of sleep for parents and children, and conflict and challenges in providing care at night. Using NVIVO software, a thematic analysis of the data will be performed. From the coded data, themes will be developed to bring greater understanding to the experience of providing care at night and to provide guidance for development of a future RCT.

Data collection for this study is complete.

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SLEEP AND ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) STUDY

Principal Investigator: S. Zupanec
Co-Investigators: H. Jones, R. Stremler
Funding: Pediatric Oncology Group of Ontario

OBJECTIVES: (1) To describe for children aged 4-18 receiving maintenance chemotherapy for precursor B or T lineage ALL: a) usual sleep habits, b) sleep disturbance, c) fatigue, and d) reasons for nighttime awakenings; (2) To determine if there is a relationship between children’s sleep disturbance, sleep habits, and fatigue; (3) To describe sleep disturbance and fatigue for parents of children receiving maintenance chemotherapy for ALL ; and (4) To determine if there is a relationship between parent sleep disturbance and fatigue and child sleep disturbance, sleep habits, and fatigue.

PARTICIPANTS: Participants included 64 parents of 63 children aged 4-18 years. All children were receiving maintenance chemotherapy for ALL and had finished the first course of chemotherapy. MEASUREMENT: Families completed Child and Parent questionnaires. The Child questionnaire included questions related to demographic and medical data (e.g. child’s age, race, treatment protocol), the Children’s Sleep Habits Questionnaire (Owens, 2000) and the Childhood Cancer Fatigue Scale (Hinds et al, 1999 and 2007). One or both parents answered questions about their sleep disturbance (measured by the General Sleep Disturbance Scale, Lee, 1991) and fatigue (measured by the Fatigue Visual Analogue Scale, Lee, 1992).

MEASUREMENT: Families completed Child and Parent questionnaires. The Child questionnaire included questions related to demographic and medical data (e.g. child’s age, race, treatment protocol), the Children’s Sleep Habits Questionnaire (Owens, 2000) and the Childhood Cancer Fatigue Scale (Hinds et al, 1999 and 2007). One or both parents answered questions about their sleep disturbance (measured by the General Sleep Disturbance Scale, Lee, 1991) and fatigue (measured by the Fatigue Visual Analogue Scale, Lee, 1992).

RESULTS: Sleep disturbance was common in both children (87%) and parents (48%) and sleep disturbance scores were positively correlated with fatigue scores. From qualitative written responses to open-ended questions, 9 themes emerged related to sleep for children undergoing maintenance chemotherapy for ALL. Sleep differences noted since diagnosis included (1) sleep is disturbed, (2) sleep habits have changed, and (3) sleep is unchanged or improved. Things that got in the way of children sleeping well included (4) side effects of medication, especially dexamethasone; and (5) medication schedules. Things that helped children get sleep at night were (6) sleeping with someone, (7) comforting activities or routine, (8) medications, and (9) food and drink. Sleep disturbance in children on ALL maintenance and their parents is common and likely contributes to increased fatigue and is a potential target for nursing interventions.

This study is complete and has been published.
For a link to the abstract, click here .

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SHARI (Sleep Hygiene And Relaxation Intervention) FOR CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA

Principal Investigator: S. Zupanec

Co-Investigators: H. Jones, J. Weston, R. Stremler

Funding: Alex’s Lemonade Stand Foundation

Children being treated for cancer have been shown to have poor sleep quality. Causes of poor sleep quality in this population have been identified and include medications, specifically steroids, sleep disruption and poor sleep habits. Sleep disruption and poor sleep quality has been found both in hospitalized children receiving chemotherapy, and in children receiving outpatient maintenance therapy for acute lymphoblastic leukemia (ALL). Poor sleep quality contributes to increased fatigue in pediatric oncology patients and fatigue has been reported as the most distressing cancer treatment related symptom. An important role for pediatric oncology nurses is to manage symptoms and side effects of cancer and cancer therapy including fatigue. Therefore nurses are challenged to decrease levels of fatigue by exploring and utilizing interventions to improve the sleep quality of children receiving cancer therapy. Sleep hygiene is one intervention that has been recommended for various sleep disorders by sleep experts and has been successful in improving sleep quality in children with sleep problems and adult cancer survivors. Sleep hygiene strategies are aimed at increasing behaviors that promote sleep (e.g. bedtime routine) and maintain a regular sleep-wake cycle (e.g. waking at about the same each day) and creating an environment conducive to sleep (e.g. cool, dark bedroom; no TV in the bedroom). Relaxation techniques are another sleep promoting intervention often provided in combination with sleep hygiene to promote feelings of calmness, decrease anxiety and minimize distressing thoughts at bedtime that might interfere with both falling asleep and staying asleep. Neither of these interventions has been tested with children receiving outpatient treatment for cancer but when combined may improve sleep quality and decrease both sleep disruption and levels of fatigue.

OBJECTIVES: The aims of this pilot study are to test the feasibility, acceptability and effectiveness of an a combined sleep hygiene and relaxation technique intervention to improve sleep quality and decrease fatigue levels in children aged 4-10 with a diagnosis of ALL receiving steroid pulses during maintenance treatment. Feasibility and acceptability will be elicited from parent completed questionnaires. Effectiveness will be measured using actigraphy and will assess nighttime sleep, nighttime waking, minutes spent awake after sleep onset, amount of daytime sleep and fatigue levels. The relationships between sleep disturbance, fatigue and school attendance will also be assessed. Data collection for this study is ongoing.

Data collection for this study is ongoing.

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LABOUR POSITION TRIAL 2

Principal Investigator: E. Hodnett, R. Stremler

Co-Investigators: R. Windrim, A. Willan

Funding: CIHR

Caesarean birth rates continue to rise, despite evidence of a two-to-threefold increase in the risk of maternal mortality and nationwide efforts to decrease them. To date no medical or nursing interventions during first stage labour in North American hospitals increase the likelihood of normal vaginal birth. Two large North American trials and two national USA surveys show that most women who labour in North American hospitals have continuous electronic fetal heart rate monitoring, regional analgesia, and intravenous oxytocin. Given the restrictions on movement posed by these interventions, it is not surprising that hospitalized women in labour spend nearly all of their time in passive positions such as semi-sitting, sitting, semi-recumbent, and side-lying.

There is little research on positioning during labour. The one position with the best evidence of benefit in promoting normal birth is hands-and-knees. Unlike many other upright positions, hands-and-knees can be achieved by a woman in a labour bed, who has had epidural analgesia. It allows gravity and buoyancy to act on the fetus, promoting rotation of the fetal head to the optimal anterior position. Our pilot trial demonstrated feasibility and provided evidence of benefit. Hands-and-knees position is a simple intervention which may promote and support the process of normal labour.

Our primary research question is: What is the effect of repeated hands-and- knees positioning on the likelihood of spontaneous vaginal birth? Secondary research questions address the effects of the position on 1) pain; 2) use of synthetic oxytocin during labour; 3) use of regional analgesia; 4) length of time from randomization to delivery; and 5) women’s evaluations of their childbirth experiences. Other research questions will address the effect of hands and knees on the likelihood of complications for the mother and baby.

Collection of pilot data for this study is currently underway.

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LABOUR POSITION TRIAL

Principal Investigator: R. Stremler
Co-Investigators: E. Hodnett, P. Petryshen, B. Stevens
Funding: CIHR, American Nurses Foundation/ Sigma Theta Tau International & Registered
Nurses Foundation of Ontario

During labor, occipitoposterior (OP) position of the fetal head is associated with operative delivery, forceps/vacuum use, perineal trauma, longer labor and persistent back pain. Understanding of fetopelvic relationships suggests that maternal adoption of hands and knees positioning during labor promotes fetal head rotation by the effects of gravity and buoyancy. This randomized controlled trial evaluated the effect of maternal hands-and-knees positioning on fetal head rotation from occipitoposterior to occipitoanterior position, persistent back pain, and other perinatal outcomes. Study participants were 147 women laboring with a fetus >37 weeks gestation and confirmed by ultrasound to be in occipitoposterior position. Participants were randomly allocated into either the intervention group (hands-and-knees positioning for at least 30 minutes over a 1-hour period during labor) or usual care group (no hands-and-knees positioning). Women randomized to the intervention group had significant reductions in persistent back pain. Trends toward benefit for the intervention group were seen for several other outcomes, including operative delivery, fetal head position at delivery, 1-minute Apgar scores, and time to delivery. Although this study demonstrates trends toward improved birth outcomes, further trials are needed to determine if hands-and-knees positioning promotes fetal head rotation to occipitoanterior and reduces operative delivery.

This trial is complete and has been published. For a link to the abstract, click here .

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BETTER NIGHTS /BETTER DAYS - IMPROVING PSYCHOSOCIAL HEALTH OUTCOMES IN CHILDREN WITH BEHAVIOURAL INSOMNIA: CIHR Sleep and Circadian Rhythms Team Grant

Principal Investigator: P. Corkum
Co-Investigators: C. Chambers, R. Godbout, R. Gruber, W. Hall, G. Reid, R. Stremler, M. Witmans, S. Weiss, B. Rusak, P. McGrath, T. Wade, M. Barwick, C.Watters, P. Andreou
Funding: CIHR

The most common sleep problem among children is behavioural insomnia, with prevalence rates as high as 25%. Behavioural insomnia is defined as “repeated difficulty with sleep initiation, duration, consolidation, or quality that occurs despite age appropriate time and opportunity for sleep, which results in some form of daytime functional impairment for the child and/or family” (Mindell et al., 2006). Although there is much less research on the impact of sleep loss in children than in adults, it is clear that poor sleep in children is associated with impairments in daytime functioning for children and parents (Sadeh 2007). Despite the high prevalence and social and health costs of this disorder, only ~1% of children with insomnia receive the behaviourally based treatments that have been proven to be safe and effective for this disorder. This arises from a combination of lack of training of most health care professionals in treating insomnia and very limited access for most parents to care providers with appropriate training.

We are proposing to bypass the bottlenecks in care delivery by developing, evaluating and disseminating an internet-based intervention for behavioural insomnia in children. This approach will make appropriate care accessible to the great majority of parents in Canada. The evaluation component of our study will also improve our understanding of how children’s sleep problems affect their daytime functioning, as well as the functioning of their parents, and what impact appropriate treatment can have. It is important to obtain this information through a large-scale experimental study, since most data available on this topic are correlational and cannot provide evidence of causal relations between sleep impairment (or appropriate treatment) and daytime functioning.

The objectives of the proposed project are: 1) development of a multi-component, web-based sleep treatment program, in both English and French, for the treatment of behavioural insomnia in children aged 1-10 years; 2) evaluation of the web-based treatment program through the use of Randomized Controlled Trials (RCT) designed to determine the impact of the intervention on children’s and parents’ sleep and psychosocial health; 3) development and evaluation of training materials as a companion to the web-based intervention program; and 4) broad dissemination of the web-based treatment programs and related training materials, followed by tracking the use and impact of both treatment programs and training materials.

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TEAM RESEARCH AND TRAINING PROGRAM: CIHR Sleep and Circadian Rhythms Team Grant

For details please see: www.utoronto.ca/sleepandrhythms

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THE CUES AND CARE TRIAL

Principal Investigators: P. Zelkowitz, N. Feeley
Co-Investigators: A. Papageorgiou, F. Lefebvre, R. Westreich, D. Dunkley, I. Shrier, Z. Rosberger,
R. Steele, R. Stremler
Funding: CIHR

The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. 122 mothers of singleton infants born at weights below 1500g were recruited in the neonatal intensive care units of 2 tertiary care hospitals, and were randomly assigned to the experimental (Cues) intervention or to an attention control (Care) condition. The Cues intervention teaches mothers to attendto their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age.

Enrollment for this trial is complete and follow-up data are currently being collected.

The protocol for this trial has been published, for a link to the abstract, click here .

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THE CUES AND CARE TRIAL FOLLOW-UP

Principal Investigators: P. Zelkowitz, N. Feeley
Co-Investigators: A. Papageorgiou, F. Lefebvre, R. Westreich, D. Dunkley, I, Shrier, Z. Rosberger, R. Steele, R. Stremler, J. Zupancic, R. Cornish
Funding: SSHRC

The purpose of the Cues and Care follow up study is to examine the longer term effects of the Cues program when the children are 2.5 years (corrected age). All mothers and children who participated in the Cues and Care trial will be included in the follow up study. A home visit will be scheduled to collect data when the child is 2.5 years corrected age. A trained research assistant blind to group assignment will administer self-report questionnaires to the mothers; these questionnaires will assess maternal anxiety, depression, and posttraumatic stress, as well as child behaviour problems and child’s social communication skills. Mother-child interaction in a free play situation will be videotaped for later coding. These interaction data will be used to assess maternal sensitivity. A psychologist who is blind to group assignment will assess the child’s development using the Bayley Scales of Infant Development (BSID-III). We expect that the longer-term impact of the intervention will be on maternal sensitivity, which is the environmental factor that is most directly related to the child’s experience.

Data collection for this follow-up study is ongoing.

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A RCT PILOT PROJECT TO EVALUATE THE EFFICACY OF MELATONIN IN CHILDREN WITH INSOMNIA, INTRACTABLE EPILEPSY AND NEURODEVELOPMENTAL DISABILITIES

Principal Investigator: S. Weiss
Co-Investigators: R. Stremler, J. MacFarlane, S. Bjelajac-Mejia, M. Zak
Funding: Hospital for Sick Children Foundation

Children with epilepsy and neurodevelopmental disabilities have difficulty in attaining good sleep. Melatonin may be a natural alternative to help attain better sleep when the problem is difficulty settling at bedtime or frequent night waking (chronic insomnia). The primary objective of this study is to evaluate the safety and efficacy of oral melatonin [fast release (FR) and controlled release (CR) formulations] in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia. A secondary objective is to determine if oral melatonin (fast release, FR and controlled release, CR) has anticonvulsant properties and decreases seizure frequency with or without improvement in sleep duration. This study is a single blinded design which will compare the effect of fast release melatonin versus placebo and controlled release melatonin versus the effect of a placebo pill in improving sleep in children with difficult to treat epilepsy and neurodevelopmental disabilities. We expect that children with neurodevelopmental disabilities and difficult to treat epilepsy will have improved sleep after receiving melatonin versus those who receive a placebo pill and their seizure frequency will also decrease.

Data collection for this study is ongoing.

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A NURSING INTERVENTION TO ENHANCE COMFORT AND PROMOTE PSYCHOLOGICAL WELL-BEING IN CHILDREN DURING AND FOLLOWING PICU HOSPITALIZATION:
A PILOT STUDY

Principal Investigator: J. Rennick
Co-Investigators: R. Stremler, E. Constantin, M. Aita, A. Majnemer, S. Baillargeon,
M. Antonacci, S. Ghosh
Funding:
GRIISIQ & Montreal Children’s Hospital

The aim of our study is to test the feasibility and acceptability of a PICU nursing intervention that seeks to enhance child comfort and promote sleep quality and duration in the PICU, potentially promoting psychological well-being post-discharge. The intervention is based on principles of Developmental Care, a philosophy of care that includes the child and family, and incorporates intervention strategies to reduce environmental stressors and improve quality of life. In view of the critically ill child’s state of physical and emotional vulnerability, and the highly noxious environmental stimuli they are exposed to in the PICU, our proposed intervention has the potential to enhance physiological and psychological stability in this population. We will examine the effects of a PICU-based comfort care intervention comprised of two components: parental soothing, including tactile and auditory strategies, followed by a quiet period with the application of headphones to block auditory stimulation. The intervention is intended to comfort the child, promote sleep and, ultimately, psychological well-being. It is also intended to reduce parent anxiety, which is closely linked to child anxiety.

Data collection for this study is ongoing.

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EFFICACY OF DETERIORATING PATIENT-BASED SIMULATION FOR IMPROVING PAIN KNOWLEDGE

Principal Investigators: M. McGillion, A. Dubrowski
Co-Investigators: C. McCartney, R. Stremler, J. Watt-Watson, I. Silver, J. Stinson, J. Hunter, S. Nelson, J. Costello, G. Tait, J.C. Victor, L. Snell, J. Wiseman, T. Dao, C. Regehr, A. Robb, H. Carnahan, M. Leegaard
Funding: Mount Sinai Hospital

Unrelieved surgical pain is a major health care crisis. Efficacious simulation methods are needed to improve health care professionals’ (HCPs’) post-operative pain assessment skills and to help HCPs’ understand, recognize, and address pain-related misbeliefs while taking a pain history.

The objective of this pilot randomized controlled trial is to test the efficacy, HCPs’ satisfaction with, and quality of two simulation-based learning models, including a standardized patient (SP) simulation, and a deterioration patient-based simulation. The study population will be 50 HCPs’ from five Toronto hospitals.

This pilot trial is being written up for publication.

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IDENTIFYING FACTORS INVOLVED IN THE PRENATAL DIAGNOSIS OF CONGENITAL HEART DEFECTS REQUIRING NEONATAL INTERVENTION

Principal Investigator: N. Dutil
Co-Investigators: E. Jaeggi, P. Pereira-Solomos, R. Stremler
Funding: Labatt Family Heart Centre

Early prenatal diagnosis has been identified as a significant step in reducing mortality and morbidity in infants with major Congenital Heart Defect(s) Requiring Neonatal Intervention (CHDRNI). The objectives of this study are to examine; (1) what health care provider characteristics, health care system characteristics and family characteristics are related to the prenatal diagnosis process; (2) what factors are involved in the prenatal diagnosis process of CHDRNI, and (3) the current rates of prenatal diagnosis of CHDRNI in Ontario. This study will be a retrospective, descriptive, cross-sectional examination of the prenatal care processes leading to the diagnosis, or lack thereof, of a CHDRNI. For a one year period, all families of fetuses and newborns with CHDRNI will be approached to participate in the study. The study format will be a survey, using a structured questionnaire, containing a mix of closed and open-ended questions. This survey of will be conducted through interviews, preferably in-person, in the clinical setting (SickKids’ NICU, CCCU, 4D, Fetal Echo Lab), or alternately, by phone (when in-person not possible), in order to collect data on each family’s prenatal diagnostic experience.

This study is currently ongoing.

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SELAN (STRUCTURED EARLY LABOUR ASSESSMENT AND CARE BY NURSES) TRIAL

Principal Investigator: E. Hodnett
Co-Investigators: W. Fraser, A. Willan, R. Stremler, A. Gafni
Funding: CIHR

The objective of this multicentre randomized controlled trial was to determine if a complex nursing and midwifery intervention in hospital labour assessment units would increase the likelihood of spontaneous vaginal birth and improve other maternal and neonatal outcomes. Participants in this trial were 5002 nulliparous women from 20 North American and UK hospitals who were experiencing contractions but were not in active labour. Particpants were allocated into either a structured care group (minimum of one hour of care by a nurse or midwife trained in structured care, consisting of a formalised approach to assessment of and interventions for maternal emotional state, pain, and fetal position) or a usual care group. Results suggest that a structured approach to care in hospital labour assessment units increased satisfaction with care and were suggestive of a modest increase in the likelihood of spontaneous vaginal birth although this increase was not statistically significant.

This trial is complete and has been published. For a link to the abstract, click here .

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THE PLACE (PREGNANT AND LABORING IN AN AMBIENT CLINICAL ENVIRONMENT) PILOT TRIAL

Principal Investigator: E. Hodnett
Co-Investigators: R. Stremler, P. McKeever

The objective of this pilot trial was to examine the feasibility, and acceptability to patients and health care providers, of a randomized trial of a modified labour room. Sixty-two women at two Toronto teaching hospitals were randomly allocated to either the standard labor room or the "ambient room." The ambient room featured the removal of the standard hospital bed and the addition of equipment to promote relaxation, mobility, and calm. Participants and their nurses and physicians completed questionnaires to elicit their views of their experiences with the labour rooms. Responses from participants and practitioners were generally very positive. Participants in the ‘ambient room’ spent less time in the hospital labour bed and fewer participants required artificial oxytocin infusions.

This pilot trial is complete and has been published. For a link to the abstract, click here .

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SLEEP AND FATIGUE AND THE RELATIONSHIP
TO PAIN, DISEASE ACTIVITY AND QUALITY OF LIFE IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) AND JUVENILE DERMATOMYOSITIS (JDM).

Principal Investigator: Y. Butbul
Co-Investigators: R. Stremler, S.M. Benseler, B. Cameron, R.M. Laxer, S. Ota, R. Schneider, E.D. Silverman, L. Spiegel, J. Stinson, B.M. Feldman
Funding: Medical Fellow Project

Objective: To determine the prevalence of disturbed sleep in juvenile idiopathic arthritis (JIA) and juvenile dermatomyositis (JDM) and its relationship to pain, function, disease activity and medications.

Materials and Methods: Patients were randomly sampled and were mailed questionnaires. Sleep disturbance was assessed by Sleep Self-Report (SSR) and Children’s Sleep Habits Questionnaires (CSHQ). Fatigue, pain and function were assessed by the Pediatric Quality of Life Inventory (PedsQL) and disease activity by visual analog scales (VAS). Joint counts were self reported.

This study is currently being written up for publication.

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