Educational Intervention for Sleep Hygiene Nursing in Adolescents (ENISHA-ST)

January 28, 2025 updated by: Maimónides Biomedical Research Institute of Córdoba

Educational Intervention for Sleep Hygiene Nursing in Adolescents: Translation to the School Nurse

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cordoba, Spain, 14005
        • Instituto Maimónides de Investigación Biomedica de Cordoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Failure to sign the informed consent and participation form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep hygiene training programme
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). The discussion topics will be the management of sleep hygiene in schoolchildren, families and teachers, and educational elements.
Behavioral: Sleep hygiene training programme

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep hygiene (Adolescent Sleep Hygiene Scale)
Time Frame: From enrollment to through study completion, an average of 1 academic year
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)
Time Frame: From enrollment to through study completion, an average of 1 academic year
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)
Time Frame: From enrollment to through study completion, an average of 1 academic year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-cognitive determinants
Time Frame: From enrollment to through study completion, an average of 1 academic year
Knowledge, attitude, subjective norm, perceived behavioural control and intention. The Sleep Knowledge Questionnaire (SKQ) scores from 0 to 20, where higher points reflect sleep knowledge. The Sleep Attitudes Questionnaire uses a 5-point Likert scale (10 to 50 points), with higher scores indicating favourable attitudes toward sleep. The Subjective Norm Scale typically has a 7-point scale (7 to 49 points) reflecting perceived social pressure. The Self-Efficacy for Sleep Scale is scored on a 10-point scale (10 to 100 points), where higher scores show more confidence in sleep management. Finally, the Sleep Intention Scale employs a 5-point scale (5 to 25 points), with higher scores signifying greater intentions to adopt positive sleep behaviours.
From enrollment to through study completion, an average of 1 academic year
Sociodemographic, family, and lifestyle and habits
Time Frame: From enrollment to through study completion, an average of 1 academic year
The research team will create a questionnaire to capture relevant variables. Participants will report sociodemographic factors like age (age ranges), sex (male, female, other), and perceived social class (lower, middle, upper). Family variables will include cohabitation status (living alone, with family, with friends) and the number of family members (1, 2-3, 4 or more). Lifestyle questions will cover physical activity levels (sedentary, moderate, active), eating habits (balanced, unhealthy, irregular), hygiene practices (daily, weekly), and substance use (none, occasional, regular tobacco, alcohol, or other drugs).
From enrollment to through study completion, an average of 1 academic year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Clinical Trials on Sleep hygiene training programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe