SleepNCT01734148
The RELAX TO SLEEP Study
A study testing Relax To Sleep Program in people with Sleep, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Sleep is a biological process essential for health. Being hospitalized can exacerbate common sleep difficulties in children. Factors that contribute to sleep disturbances during hospitalization include environmental, physiological, and psychological factors. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Sleep
- What is being tested?
- Relax To Sleep Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 4 and 10.
- Children expected to stay for 3 nights.
- Children must have a parent present that plans to stay overnight with the child and must understand English (parent must read English).
- Child must be in a single private room.
Who cannot join
- Children who are receiving palliative care only during their hospital admission.
- Children diagnosed with a sleep disorder or a clinical anxiety disorder.
- Children with limited or abnormal movements of both upper and lower extremities (e.g. paralysis, brain injury, cerebral palsy, use of drugs to induce paralysis, musculoskeletal impairments, use of restraints, under heavy sedation), thereby impairing sleep wake activity recording and the inability to use the relaxation breathing exercise.
- Children who are too acutely ill to participate in the study.
- Children who have major cognitive impairments that may impact their ability to understand and carry out the intervention.
- Children who are heavily sedated or receiving benzodiazepines or chloral hydrate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial
Sleep is a biological process essential for health. Being hospitalized can exacerbate common sleep difficulties in children. Factors that contribute to sleep disturbances during hospitalization include environmental, physiological, and psychological factors. Although sleep interventions exist for healthy children in the community, interventions aimed at hospitalized children need to be developed and piloted with rigorous evaluative methods. The primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO SLEEP program on hospitalized children. Although this study is a pilot study, comparisons will be made to examine sleep outcomes between the intervention group and the control group including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety levels and the development of post-hospital maladaptive behaviours.
- Conditions
- Sleep
- Being tested
- Relax To Sleep Program
- Keywords
- pediatric, sleep difficulties in children, Sleep Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relax To Sleep ProgramBehavioural
The educational portion of the program will consist of a standardized educational booklet and a discussion with the PI and provides a brief overview will be given on normal sleep and sleep patterns, children's sleep needs, and the signs and consequences of sleep disturbance. Second, the educational booklet provides sleep hygiene info. The second component consists of of good sleep habits such as having a regular sleep-wake schedule, avoiding caffeine intake prior to sleep, avoiding stimulating activities near nighttime sleep, avoidance of naps during the day, ensuring that the child is exposed to natural light during the day, providing the child with opportunities to socialize during the day. Finally, the program consists of a relaxation breathing technique for the child.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (RELAX TO SLEEP program) | Experimental | Not described Receives: Behavioral: Relax To Sleep Program |
| Control group (Usual Care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nocturnal sleep at hospital
Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.
Measured: total measured over 3 days and 3 nights
Secondary outcomes (2)
Anxiety
Anxiety will be measured using the Spence Pre-school anxiety scale for children 4 to 5 years of age , and the Spence Children's Anxiety Scale (SCAS) for children ages 6-10
Measured: Baseline, Day 5
Post-hospital maladaptive behaviours
member of the research team will make contact within 5-7 days post-discharge by telephone and ask them to complete the Post-Hospital Behaviour Questionnaire (PHBQ), a self-report questionnaire for parents most commonly used for assessing children's post-hospital behaviour
Measured: Follow-up (5-7 days post discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startSep 2011
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robyn Stremler, The Hospital for Sick Children
- Investigators
- Robyn Stremler, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734148
- Sponsor's protocol ID
- 10000 26217
- Status last verified
- Sep 2019
- First submitted
- 21 Nov 2012
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Papaconstantinou EA, Hodnett E, Stremler R. A Behavioral-Educational Intervention to Promote Pediatric Sleep During Hospitalization: A Pilot Randomized Controlled Trial. Behav Sleep Med. 2018 Jul-Aug;16(4):356-370. doi: 10.1080/15402002.2016.1228639. Epub 2016 Sep 15.
PubMed 27633943
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01734148
- Acronym / sponsor ID
- 10000 26217
- Conditions
- Sleep
- Keywords
- pediatric, sleep difficulties in children, Sleep Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep is a biological process essential for health. Being hospitalized can exacerbate common sleep difficulties in children. Factors that contribute to sleep disturbances during hospitalization include environmental, physiological, and psychological factors. Although sleep interventions exist for healthy children in the community, interventions aimed at hospitalized children need to be developed and piloted with rigorous evaluative methods. The primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO SLEEP program on hospitalized children. Although this study is a pilot study, comparisons will be made to examine sleep outcomes between the intervention group and the control group including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety levels and the development of post-hospital maladaptive behaviours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (RELAX TO SLEEP program) | Experimental | Behavioral: Relax To Sleep Program |
| Control group (Usual Care) | No intervention | – |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 4 and 10.
- Children expected to stay for 3 nights.
- Children must have a parent present that plans to stay overnight with the child and must understand English (parent must read English).
- Child must be in a single private room.
Key exclusion criteria (6 listed)
- Children who are receiving palliative care only during their hospital admission.
- Children diagnosed with a sleep disorder or a clinical anxiety disorder.
- Children with limited or abnormal movements of both upper and lower extremities (e.g. paralysis, brain injury, cerebral palsy, use of drugs to induce paralysis, musculoskeletal impairments, use of restraints, under heavy sedation), thereby impairing sleep wake activity recording and the inability to use the relaxation breathing exercise.
- Children who are too acutely ill to participate in the study.
- Children who have major cognitive impairments that may impact their ability to understand and carry out the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relax To Sleep ProgramThe educational portion of the program will consist of a standardized educational booklet and a discussion with the PI and provides a brief overview will be given on normal sleep and sleep patterns, children's sleep needs, and the signs and consequences of sleep disturbance. Second, the educational booklet provides sleep hygiene info. The second component consists of of good sleep habits such as having a regular sleep-wake schedule, avoiding caffeine intake prior to sleep, avoiding stimulating activities near nighttime sleep, avoidance of naps during the day, ensuring that the child is exposed to natural light during the day, providing the child with opportunities to socialize during the day. Finally, the program consists of a relaxation breathing technique for the child. | Behavioural | Experimental group (RELAX TO SLEEP program) |
Primary outcome
Total nocturnal sleep at hospital
Time frame: total measured over 3 days and 3 nights
Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.
2 secondary outcomes
Anxiety
Time frame: Baseline, Day 5
Post-hospital maladaptive behaviours
Time frame: Follow-up (5-7 days post discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Results publication: PubMed 27633943Papaconstantinou EA, Hodnett E, Stremler R. A Behavioral-Educational Intervention to Promote Pediatric Sleep During Hospitalization: A Pilot Randomized Controlled Trial. Behav Sleep Med. 2018 Jul-Aug;16(4):356-370. doi: 10.1080/15402002.2016.1228639. Epub 2016 Sep 15.
Related trials for Sleep
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
Enrolling by invitationObservational study
Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
Cardiometabolic Health
Not yet recruitingObservational study
Heart and Brain Blood Flow in Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
Psychological Distress, Insomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Stremler principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relax To Sleep Program in people with Sleep, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total nocturnal sleep at hospital (time frame: total measured over 3 days and 3 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.