Sleep HygieneNCT07190872
Sleep Hygiene Education in Associate Degree Health Sciences Students: A Randomized Controlled Trial
A study testing sleep hygiene education in people with Sleep Hygiene, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effect of a Transtheoretical Model-guided sleep hygiene education program on sleep hygiene behaviors, sleep quality, and sleep hygiene knowledge among associate degree health sciences students participating in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Sleep Hygiene
- What is being tested?
- sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2025to 28 Nov 2025
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being an associate degree student at the School of Health Services - Participating in hospital clinical practice - Being between 18 and 25 years of age - Scoring 30 or higher on the Sleep Hygiene Index (SHI) - Voluntarily agreeing to participate in the study - Providing written informed consent - Not having received any sleep hygiene education within the previous 3 months - Being able to participate regularly throughout the study process
Who cannot join
- Having a diagnosed sleep disorder - Having a diagnosed psychiatric condition that could affect mental health and/or regularly taking psychiatric medication - Having a chronic illness and regularly taking medication - Working night shifts or having an irregular sleep schedule - Being unable to participate regularly throughout the study process - Failing to comply with the study intervention
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University, School of Health Services
Bilecik, Bilecik, 11100
About this study
Official title: The Effect of Sleep Hygiene Education on Sleep Hygiene Behaviors and Sleep Quality Among Associate Degree Students in the Health Sciences Participating in Clinical Practice: A Randomized Controlled Trial
This randomized controlled trial evaluated the effect of a Transtheoretical Model-guided sleep hygiene education program on sleep hygiene behaviors, sleep quality, and sleep hygiene knowledge among associate degree health sciences students participating in clinical practice.
A total of 100 students enrolled in Operating Room Services, Dialysis, and Emergency Medical Services programs were randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group received four weekly, face-to-face sleep hygiene education sessions, each lasting approximately 40 minutes, together with brief one-way WhatsApp reminders three times per week. The control group received no sleep-related educational intervention during the study period.
Assessments were conducted before randomization and after completion of the four-week intervention. Sleep hygiene behaviors were assessed using the Sleep Hygiene Index, sleep quality using the Pittsburgh Sleep Quality Index, and sleep hygiene knowledge using a researcher-developed Sleep Hygiene Knowledge Test. The study aimed to determine whether the structured educational intervention improved sleep hygiene behaviors and sleep quality compared with no intervention.
Read the detailed description
This study was conducted as a pre-test-post-test, parallel-group randomized controlled trial to evaluate the effect of a Transtheoretical Model-guided sleep hygiene education program on sleep hygiene behaviors, sleep quality, and sleep hygiene knowledge among associate degree health sciences students participating in clinical practice.
The study included 100 students enrolled in the Operating Room Services, Dialysis, and Emergency Medical Services programs at a School of Health Services affiliated with a state university in northwestern Türkiye. Eligible participants provided written informed consent and completed baseline assessments before randomization. Participants were randomly allocated in a 1:1 ratio to an intervention group (n=50) or a control group (n=50) using a pre-generated simple randomization sequence.
The intervention group received a four-week, face-to-face sleep hygiene education program guided by the Transtheoretical Model. Four sessions were conducted on December 3, 10, 17, and 24, 2025. Each session lasted approximately 40 minutes. The sessions progressed from awareness and reflection on current sleep-related behaviors to preparation, goal setting, implementation of behavior-change strategies, and maintenance-oriented planning. The educational content included sleep hygiene principles, regular sleep schedules, caffeine and screen use, sleep environment, physical activity, stress management, relaxation strategies, and preparation of an individual sleep plan. Brief one-way WhatsApp reminders related to sleep hygiene were also sent to intervention-group participants three times per week during daytime hours. The control group received no sleep-related educational intervention during the study period.
Data were collected using the Student Life and Sleep Factors Questionnaire, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, and a researcher-developed 10-item Sleep Hygiene Knowledge Test. The Sleep Hygiene Index was used to assess sleep hygiene behaviors, with higher scores indicating poorer sleep hygiene. The Pittsburgh Sleep Quality Index was used to assess sleep quality, with higher scores indicating poorer sleep quality. The Sleep Hygiene Knowledge Test was used as an intervention-specific measure of sleep hygiene knowledge.
The study procedure consisted of eligibility screening, informed consent, baseline assessment, randomization, intervention, and post-intervention assessment. After completion of the fourth educational session on November 28, 2025, post-test assessments were completed in both groups using the same outcome measures. Sleep hygiene behaviors and sleep quality were considered the main study outcomes, while sleep hygiene knowledge was evaluated as an additional outcome.
- Conditions
- Sleep Hygiene
- Being tested
- sleep hygiene education
- Keywords
- sleep hygiene, sleep quality, behavior change, transtheoretical model
- Medical subject headings
- Sleep Hygiene, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep hygiene educationBehavioural
The intervention consisted of a four-session, face-to-face sleep hygiene education program guided by the Transtheoretical Model. Sessions were delivered once weekly for approximately 40 minutes by a nurse with at least five years of professional experience in sleep health. The educational content included sleep hygiene principles, regular sleep schedules, caffeine and screen use, sleep environment, physical activity, stress management, relaxation strategies, individual goal setting, preparation of a personal sleep plan, and strategies for maintaining healthy sleep behaviors. Brief one-way WhatsApp reminders were sent three times per week during daytime hours to support the educational content.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Education (Experimental Intervention Arm) | Experimental | Participants randomized to the intervention group received four weekly face-to-face sleep hygiene education sessions in December 2025. Each session lasted approximately 40 minutes. The education was guided by the Transtheoretical Model and was supported by brief one-way WhatsApp reminders sent three times per week during daytime hours. Receives: Behavioral: sleep hygiene education |
| Control Group | No intervention | Students in the control group will not receive any educational intervention or message support during the study period; they will continue with their daily routines. Assessments are conducted at the same time points as the intervention group. After the study is completed, the same training materials will be made available to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Hygiene Index (SHI) Total Score
Sleep hygiene behaviors were assessed using the Sleep Hygiene Index (SHI), a 13-item instrument scored on a 5-point Likert scale. Total scores range from 13 to 65, with higher scores indicating poorer sleep hygiene behaviors. The outcome was evaluated by comparing the change in SHI total score from baseline to the post-intervention assessment between the intervention and control groups.
Measured: Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The outcome was evaluated by comparing the change in PSQI total score from baseline to the post-intervention assessment between the intervention and control groups.
Measured: Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)
Secondary outcomes (1)
Change in Sleep Hygiene Knowledge Test Score
Sleep hygiene knowledge was assessed using a researcher-developed 10-item multiple-choice Sleep Hygiene Knowledge Test. Correct responses were scored as 1 and incorrect responses as 0, yielding a total score ranging from 0 to 10. Higher scores indicate greater sleep hygiene knowledge. The outcome was evaluated by comparing the change in total score from baseline to the post-intervention assessment between the intervention and control groups.
Measured: Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start30 Oct 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HygieneStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to an intervention group or a control group using a pre-generated simple randomization sequence. The intervention group received four weekly face-to-face sleep hygiene education sessions guided by the Transtheoretical Model, while the control group received no educational intervention during the study period. Baseline assessments were completed before randomization, and post-intervention assessments were completed after the four-week intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Gümüş, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190872
- Sponsor's protocol ID
- BilecikSeyhEU-CH-DG-01
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Hygiene Education on Sleep Hygiene Behaviors and Sleep Quality Among Associate Degree Students in the Health Sciences Participating in Clinical Practice: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07190872
- Acronym / sponsor ID
- BilecikSeyhEU-CH-DG-01
- Conditions
- Sleep Hygiene
- Keywords
- sleep hygiene, sleep quality, behavior change, transtheoretical model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 24 Sep 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.
This randomized controlled trial evaluated the effect of a Transtheoretical Model-guided sleep hygiene education program on sleep hygiene behaviors, sleep quality, and sleep hygiene knowledge among associate degree health sciences students participating in clinical practice.
A total of 100 students enrolled in Operating Room Services, Dialysis, and Emergency Medical Services programs were randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group received four weekly, face-to-face sleep hygiene education sessions, each lasting approximately 40 minutes, together with brief one-way WhatsApp reminders three times per week. The control group received no sleep-related educational intervention during the study period.
Assessments were conducted before randomization and after completion of the four-week intervention. Sleep hygiene behaviors were assessed using the Sleep Hygiene Index, sleep quality using the Pittsburgh Sleep Quality Index, and sleep hygiene knowledge using a researcher-developed Sleep Hygiene Knowledge Test. The study aimed to determine whether the structured educational intervention improved sleep hygiene behaviors and sleep quality compared with no intervention.
Detailed description
This study was conducted as a pre-test-post-test, parallel-group randomized controlled trial to evaluate the effect of a Transtheoretical Model-guided sleep hygiene education program on sleep hygiene behaviors, sleep quality, and sleep hygiene knowledge among associate degree health sciences students participating in clinical practice.
The study included 100 students enrolled in the Operating Room Services, Dialysis, and Emergency Medical Services programs at a School of Health Services affiliated with a state university in northwestern Türkiye. Eligible participants provided written informed consent and completed baseline assessments before randomization. Participants were randomly allocated in a 1:1 ratio to an intervention group (n=50) or a control group (n=50) using a pre-generated simple randomization sequence.
The intervention group received a four-week, face-to-face sleep hygiene education program guided by the Transtheoretical Model. Four sessions were conducted on December 3, 10, 17, and 24, 2025. Each session lasted approximately 40 minutes. The sessions progressed from awareness and reflection on current sleep-related behaviors to preparation, goal setting, implementation of behavior-change strategies, and maintenance-oriented planning. The educational content included sleep hygiene principles, regular sleep schedules, caffeine and screen use, sleep environment, physical activity, stress management, relaxation strategies, and preparation of an individual sleep plan. Brief one-way WhatsApp reminders related to sleep hygiene were also sent to intervention-group participants three times per week during daytime hours. The control group received no sleep-related educational intervention during the study period.
Data were collected using the Student Life and Sleep Factors Questionnaire, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, and a researcher-developed 10-item Sleep Hygiene Knowledge Test. The Sleep Hygiene Index was used to assess sleep hygiene behaviors, with higher scores indicating poorer sleep hygiene. The Pittsburgh Sleep Quality Index was used to assess sleep quality, with higher scores indicating poorer sleep quality. The Sleep Hygiene Knowledge Test was used as an intervention-specific measure of sleep hygiene knowledge.
The study procedure consisted of eligibility screening, informed consent, baseline assessment, randomization, intervention, and post-intervention assessment. After completion of the fourth educational session on November 28, 2025, post-test assessments were completed in both groups using the same outcome measures. Sleep hygiene behaviors and sleep quality were considered the main study outcomes, while sleep hygiene knowledge was evaluated as an additional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to an intervention group or a control group using a pre-generated simple randomization sequence. The intervention group received four weekly face-to-face sleep hygiene education sessions guided by the Transtheoretical Model, while the control group received no educational intervention during the study period. Baseline assessments were completed before randomization, and post-intervention assessments were completed after the four-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Education (Experimental Intervention Arm) | Experimental | Behavioral: sleep hygiene educationParticipants randomized to the intervention group received four weekly face-to-face sleep hygiene education sessions in December 2025. Each session lasted approximately 40 minutes. The education was guided by the Transtheoretical Model and was supported by brief one-way WhatsApp reminders sent three times per week during daytime hours. |
| Control Group | No intervention | –Students in the control group will not receive any educational intervention or message support during the study period; they will continue with their daily routines. Assessments are conducted at the same time points as the intervention group. After the study is completed, the same training materials will be made available to the control group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being an associate degree student at the School of Health Services - Participating in hospital clinical practice - Being between 18 and 25 years of age - Scoring 30 or higher on the Sleep Hygiene Index (SHI) - Voluntarily agreeing to participate in the study - Providing written informed consent - Not having received any sleep hygiene education within the previous 3 months - Being able to participate regularly throughout the study process
Key exclusion criteria (1 listed)
- Having a diagnosed sleep disorder - Having a diagnosed psychiatric condition that could affect mental health and/or regularly taking psychiatric medication - Having a chronic illness and regularly taking medication - Working night shifts or having an irregular sleep schedule - Being unable to participate regularly throughout the study process - Failing to comply with the study intervention
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 educationThe intervention consisted of a four-session, face-to-face sleep hygiene education program guided by the Transtheoretical Model. Sessions were delivered once weekly for approximately 40 minutes by a nurse with at least five years of professional experience in sleep health. The educational content included sleep hygiene principles, regular sleep schedules, caffeine and screen use, sleep environment, physical activity, stress management, relaxation strategies, individual goal setting, preparation of a personal sleep plan, and strategies for maintaining healthy sleep behaviors. Brief one-way WhatsApp reminders were sent three times per week during daytime hours to support the educational content. | Behavioural | Sleep Hygiene Education (Experimental Intervention Arm) |
Primary outcome
Change in Sleep Hygiene Index (SHI) Total Score
Time frame: Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)
Sleep hygiene behaviors were assessed using the Sleep Hygiene Index (SHI), a 13-item instrument scored on a 5-point Likert scale. Total scores range from 13 to 65, with higher scores indicating poorer sleep hygiene behaviors. The outcome was evaluated by comparing the change in SHI total score from baseline to the post-intervention assessment between the intervention and control groups.
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
Time frame: Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The outcome was evaluated by comparing the change in PSQI total score from baseline to the post-intervention assessment between the intervention and control groups.
1 secondary outcome
Change in Sleep Hygiene Knowledge Test Score
Time frame: Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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 education in people with Sleep Hygiene, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
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 1 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 21 Sep 2026. 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 Turkey (Türkiye). 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?
Change in Sleep Hygiene Index (SHI) Total Score (time frame: Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)). The study lists 2 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 21 Sep 2026.