School-based InterventionENISHA-STNCT06805708
Educational Intervention for Sleep Hygiene Nursing in Adolescents
A study testing Sleep hygiene training programme in people with School-based Intervention and Sleep, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- School-based Intervention, Sleep
- What is being tested?
- Sleep hygiene training programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Failure to sign the informed consent and participation form
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Maimónides de Investigación Biomedica de Cordoba
Córdoba, Cordoba, 14005
About this study
Official title: 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).
- Conditions
- School-based Intervention, Sleep
- Being tested
- Sleep hygiene training programme
- Keywords
- School setting, Sleep pattern, Physical activity, Nursing, Health Promotion, Prevention and monitoring, Participatory action research
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene training programmeBehavioural
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:
- Management of sleep hygiene in schoolchildren, families and teachers:
- Surveys (quantitative approach)
- Focus groups (qualitative approach)
- The study will identify the health assets
- Educational elements
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep hygiene training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to through study completion, an average of 1 academic year
Secondary outcomes (2)
Socio-cognitive determinants
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.
Measured: From enrollment to through study completion, an average of 1 academic year
Sociodemographic, family, and lifestyle and habits
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).
Measured: From enrollment to through study completion, an average of 1 academic year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start15 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School-based InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participatory Action Research (PAR) focusing on cognitive-behavioural counselling
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805708
- Sponsor's protocol ID
- 5481
- Acronym
- ENISHA-ST
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention for Sleep Hygiene Nursing in Adolescents: Translation to the School Nurse
- ClinicalTrials.gov ID
- NCT06805708
- Acronym / sponsor ID
- ENISHA-ST / 5481
- Conditions
- School-based Intervention, Sleep
- Keywords
- School setting, Sleep pattern, Physical activity, Nursing, Health Promotion, Prevention and monitoring, Participatory action research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participatory Action Research (PAR) focusing on cognitive-behavioural counselling
| Arm | Type | Receives |
|---|---|---|
| Sleep hygiene training programme | Experimental | Behavioral: Sleep hygiene training programmeA 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. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Failure to sign the informed consent and participation form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep hygiene training programmeA 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 | Behavioural | Sleep hygiene training programme |
Primary outcome
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.
2 secondary outcomes
Socio-cognitive determinants
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene training programme in people with School-based Intervention and Sleep, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep hygiene (Adolescent Sleep Hygiene Scale) (time frame: From enrollment to through study completion, an average of 1 academic year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.