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Clinical Trials/NCT06805708
NCT06805708CompletedNot Applicable

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

Maimónides Biomedical Research Institute of Córdoba1 site in 1 country200 target enrollmentStarted: October 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Sleep hygiene (Adolescent Sleep Hygiene Scale)

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
13 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Sleep hygiene training programme

Experimental

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.

Intervention: Sleep hygiene training programme (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Sociodemographic, family, and lifestyle and habits(From enrollment to through study completion, an average of 1 academic year)
  • Socio-cognitive determinants(From enrollment to through study completion, an average of 1 academic year)

Investigators

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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