<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01734148</url>
  </required_header>
  <id_info>
    <org_study_id>10000 26217</org_study_id>
    <nct_id>NCT01734148</nct_id>
  </id_info>
  <brief_title>The RELAX TO SLEEP Study</brief_title>
  <official_title>The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep is a biological process essential for health. Being hospitalized can exacerbate common&#xD;
      sleep difficulties in children. Factors that contribute to sleep disturbances during&#xD;
      hospitalization include environmental, physiological, and psychological factors. Although&#xD;
      sleep interventions exist for healthy children in the community, interventions aimed at&#xD;
      hospitalized children need to be developed and piloted with rigorous evaluative methods. The&#xD;
      primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO&#xD;
      SLEEP program on hospitalized children. Although this study is a pilot study, comparisons&#xD;
      will be made to examine sleep outcomes between the intervention group and the control group&#xD;
      including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of&#xD;
      nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety&#xD;
      levels and the development of post-hospital maladaptive behaviours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total nocturnal sleep at hospital</measure>
    <time_frame>total measured over 3 days and 3 nights</time_frame>
    <description>Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Baseline, Day 5</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-hospital maladaptive behaviours</measure>
    <time_frame>Follow-up (5-7 days post discharge)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Experimental group (RELAX TO SLEEP program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group (Usual Care)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relax To Sleep Program</intervention_name>
    <description>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.</description>
    <arm_group_label>Experimental group (RELAX TO SLEEP program)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children between the ages of 4 and 10.&#xD;
&#xD;
          2. Children expected to stay for 3 nights.&#xD;
&#xD;
          3. Children must have a parent present that plans to stay overnight with the child and&#xD;
             must understand English (parent must read English).&#xD;
&#xD;
          4. Child must be in a single private room.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children who are receiving palliative care only during their hospital admission.&#xD;
&#xD;
          2. Children diagnosed with a sleep disorder or a clinical anxiety disorder.&#xD;
&#xD;
          3. Children with limited or abnormal movements of both upper and lower extremities (e.g.&#xD;
             paralysis, brain injury, cerebral palsy, use of drugs to induce paralysis,&#xD;
             musculoskeletal impairments, use of restraints, under heavy sedation), thereby&#xD;
             impairing sleep wake activity recording and the inability to use the relaxation&#xD;
             breathing exercise.&#xD;
&#xD;
          4. Children who are too acutely ill to participate in the study.&#xD;
&#xD;
          5. Children who have major cognitive impairments that may impact their ability to&#xD;
             understand and carry out the intervention.&#xD;
&#xD;
          6. Children who are heavily sedated or receiving benzodiazepines or chloral hydrate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robyn Stremler</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5V1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>27633943</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Robyn Stremler</investigator_full_name>
    <investigator_title>Nursing Research Associate</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>sleep difficulties in children</keyword>
  <keyword>Sleep Education</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01734148
org study id: 10000 26217
nct id: NCT01734148
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Total nocturnal sleep at hospital
time frame: total measured over 3 days and 3 nights
description: Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.
measure: Anxiety
time frame: Baseline, Day 5
description: 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
measure: Post-hospital maladaptive behaviours
time frame: Follow-up (5-7 days post discharge)
description: 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
arm group label: Experimental group (RELAX TO SLEEP program)
arm group type: Experimental
arm group label: Control group (Usual Care)
arm group type: No Intervention
intervention type: Behavioral
intervention name: Relax To Sleep Program
description: 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.
arm group label: Experimental group (RELAX TO SLEEP program)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: No
last name: Robyn Stremler
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
citation: 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.
PMID: 27633943
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Robyn Stremler
investigator title: Nursing Research Associate