Clinical trial NCT06805708: Educational Intervention for Sleep Hygiene Nursing in Adolescents
Official title: Educational Intervention for Sleep Hygiene Nursing in Adolescents: Translation to the School Nurse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School-based Intervention
Sleep
Keywords: School setting
Sleep pattern
Physical activity
Nursing
Health Promotion
Prevention and monitoring
Participatory action research
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participatory Action Research (PAR) focusing on cognitive-behavioural counselling
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Sleep hygiene (Adolescent Sleep Hygiene Scale)
timeFrame: From enrollment to through study completion, an average of 1 academic year
measure: Sleep quality (Pittsburgh Sleep Quality Index)
timeFrame: From enrollment to through study completion, an average of 1 academic year
measure: Sleep duration (sleep diaries)
timeFrame: From enrollment to through study completion, an average of 1 academic year
Secondary outcomes:
measure: Socio-cognitive determinants
timeFrame: From enrollment to through study completion, an average of 1 academic year
measure: Sociodemographic, family, and lifestyle and habits
timeFrame: From enrollment to through study completion, an average of 1 academic year
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Instituto Maimónides de Investigación Biomedica de Cordoba
Study officials:
References: