Educational Intervention for Sleep Hygiene Nursing in Adolescents

NCT ID: NCT06805708

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

School-based Intervention Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participatory Action Research (PAR) focusing on cognitive-behavioural counselling
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sleep hygiene training programme

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Maimónides de Investigación Biomedica de Cordoba

Córdoba, Cordoba, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5481

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Step-by-Step: Evaluation of a Stepped Care Model
NCT06902649 NOT_YET_RECRUITING NA
Pathways 2 Success
NCT06831123 RECRUITING PHASE1/PHASE2