Educational Intervention for Sleep Hygiene Nursing in Adolescents
ENISHA-ST
1 other identifier
interventional
200
1 country
1
Brief Summary
There is an urgent need to influence the knowledge and beliefs associated with sleep (TV viewing, use of electronic devices, sedentary activity...) of school children through holistic interventions involving students, parents, teachers and other professionals in the education sector that can positively influence education. The project's main objective is to determine the acceptability and effectiveness of a school intervention consisting of counselling by family and community nurses. The methodological approach is Participatory Action Research (PAR), developed in three phases: exploratory, intervention, and evaluation. In the exploratory phase, which corresponds to a research study with a qualitative (focus groups and content analysis) and quantitative (questionnaires) approach, the study subjects will be students in the second year of secondary education in five schools in southern Spain (city and province), as well as parents and teachers. Sampling will be probabilistic. Following the action research cycle, the results of the exploration phase will be shared with all participants and will be considered for the intervention phase. This phase will aim to conceptualise/implement a sleep hygiene programme. It will take into account key aspects such as (i) health education, (ii) sleep hygiene, (iii) breathing control to facilitate sleep, (iv) sleep restriction, and (v) stimulus control. The programme will be implemented during 12 sessions of 30 minutes (intensive phase: 1 session/week for 3 weeks; maintenance phase: 1 session every 2 weeks) and will focus on cognitive-behavioural counselling. The intervention will be applied to the referred students from the participating schools. For this phase, the data analysis will be quantitative (pre-post intervention). The evaluation phase will occur 6 and 12 months after the intervention, with the same methodological approach as in the exploratory phase (quantitative and qualitative).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedFirst Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedFebruary 3, 2025
January 1, 2025
1.2 years
January 17, 2025
January 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sleep hygiene (Adolescent Sleep Hygiene Scale)
The ASHS is a 32-item self-report measure used to assess adolescent sleep hygiene (LeBourgeois et al., 2005). The ASHS includes four qualitative items to ascertain usual bedtime and wake time on weekdays and weekends and 28 quantitative items that are used to calculate nine subscale scores: physiological (5 items), cognitive (6 items), emotional (3 items), sleep environment (4 items), daytime sleep (1 item), substances (2 items), sleep stability (4 items), bedtime routine (1 item) and bed sharing (2 items). Response choices are on a 6-point ordinal scale: 1 = Never (0%); 2 = Once in a while (20%); 3 = sometimes (40%); 4 = quite often (60%); 5 = frequently, if not always (80%); 6 = always (100%). Scoring: Each subscale score is calculated by taking the average of the items comprising that subscale.
From enrollment to through study completion, an average of 1 academic year
Sleep quality (Pittsburgh Sleep Quality Index)
The questionnaire consists of a combination of Likert-type and open-ended questions. Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.
From enrollment to through study completion, an average of 1 academic year
Sleep duration (sleep diaries)
Sleep diary includes entries for bedtimes, wake-up times, the number and duration of awakenings during the night, overall sleep duration, perceived quality of sleep, and daily activities that might affect sleep, such as caffeine or alcohol intake, exercise, and naps.
From enrollment to through study completion, an average of 1 academic year
Secondary Outcomes (2)
Socio-cognitive determinants
From enrollment to through study completion, an average of 1 academic year
Sociodemographic, family, and lifestyle and habits
From enrollment to through study completion, an average of 1 academic year
Study Arms (1)
Sleep hygiene training programme
EXPERIMENTALA programme focusing on cognitive-behavioural counselling. The programme will be delivered in 12 sessions of 30 minutes each (intensive phase: 1 session per week for 3 weeks; maintenance phase: 1 session every 2 weeks). The discussion topics will be the management of sleep hygiene in schoolchildren, families and teachers, and educational elements.
Interventions
A programme focusing on cognitive-behavioural counselling. The programme will be delivered in 12 sessions of 30 minutes each (intensive phase: 1 session per week for 3 weeks; maintenance phase: 1 session every 2 weeks). After each meeting, the research group members will provide a short-written report reflecting the main discussion topics, the degree of participation, and the group's position in the participatory action research cycle. The discussion topics will be: 1. Management of sleep hygiene in schoolchildren, families and teachers: * Surveys (quantitative approach) * Focus groups (qualitative approach) * The study will identify the health assets 2. Educational elements
Eligibility Criteria
You may qualify if:
- All schoolchildren aged between 13-16 years who provide signed consent and participation by their parents/legal guardian.
- Schoolchildren taking medication that interferes with the sleep/wakefulness pattern or presenting pathologies that alter the sleep pattern (respiratory, digestive...) will also be considered.
- Family members of schoolchildren and teaching staff who agree to participate in the study will be included.
You may not qualify if:
- Failure to sign the informed consent and participation form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Maimónides de Investigación Biomedica de Cordoba
Córdoba, Cordoba, 14005, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
February 3, 2025
Study Start
October 15, 2022
Primary Completion
December 31, 2023
Study Completion
July 31, 2024
Last Updated
February 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL