NCT07190872

Brief Summary

This study looks at sleep hygiene-the daily habits and environment that help people sleep well-among 2nd-year students at the Health Services Vocational School of Bilecik Şeyh Edebali University (Türkiye). Many health sciences students have busy schedules, clinical practice, and exam stress, which may reduce sleep quality. Good sleep is important for learning, attention, mood, and overall health. Purpose: The aim is to assess the current sleep hygiene and quality of students, and determine whether a brief, in-person education program can enhance their knowledge, habits, and sleep quality in the upcoming weeks. Who can take part: The program is designed for daytime (normal education) 2nd-year students in programs such as Operating Room Services, Paramedic, Opticianry, Pharmacy Services, Medical Laboratory Techniques, Medical Documentation and Secretariat, and Child Development who volunteer and give written consent. Participation is voluntary, and you may leave the study at any time without any penalty. What will happen if you join: You will complete short forms before the education session to measure sleep habits and sleep quality (for example, bedtime, caffeine use, and screen time). You will attend four classroom sessions (each about 40 minutes). These sessions explain practical sleep tips (regular bed/wake times, reducing evening caffeine and screen time, preparing a quiet/dark room, simple relaxation after clinical shifts) and help you create a personal sleep plan. You will fill out the same forms again 2 weeks and 4 weeks after the education to see changes over time. What we measure: Sleep hygiene behaviors (how often helpful/unhelpful habits are used) Sleep quality refers to how restful sleep feels, the time it takes to fall asleep, the frequency of night awakenings, and overall daytime functioning. Knowledge about sleep hygiene (a short quiz) We will also look at factors like stress level, evening screen use, and caffeine intake. Possible benefits: You may learn practical ways to improve sleep, which can help with attention, mood, and daily performance. Possible risks/discomforts: This is an educational program. Risks are minimal (for example, brief discomfort when answering personal questions about sleep). You can skip any question you do not want to answer. Privacy: All information will be kept confidential and used only for research. Reports will not include names or identifying details. Costs and payment: There is no cost to taking part, and there is no payment for participation. Withdrawal: Participation is voluntary. You may stop at any time without affecting your courses or grades.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 17, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

sleep hygienesleep qualitybehavior changetranstheoretical model

Outcome Measures

Primary Outcomes (1)

  • Total score on the Sleep Hygiene Index

    The Sleep Hygiene Index is a 13-item, 5-point Likert scale; the total score is 13-65, with a higher score indicating poorer sleep hygiene. Turkish validity and reliability have been reported. The primary outcome is the within-participant total UHI score change (T2-T0) and the between-group mean change difference (intervention - control; negative values indicate improvement). The scale is administered in the classroom setting using standard instructions and in self-report format.

    Baseline (T0) → Week 4 (T2). Interim analysis: Week 2 (T1); optional long-term: Month 3 (T3). The primary analysis is on T2.

Study Arms (2)

Sleep Hygiene Education (Experimental Intervention Arm)

EXPERIMENTAL

Students in the intervention group will receive face-to-face sleep hygiene education in a total of 4 sessions, once a week for 40 minutes over a period of four weeks. The education is designed within the framework of the Transtheoretical Model and focuses on topics such as the concept of sleep hygiene, regular sleep hours, limiting caffeine and screen use, organizing the sleep environment, and stress management. The training will be provided by a nurse experienced in sleep health.

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.

Interventions

Students in the intervention group will receive face-to-face sleep hygiene training in a total of 4 sessions, once a week for 40 minutes over a period of four weeks. The education is designed within the framework of the Transtheoretical Model and focuses on topics such as the concept of sleep hygiene, regular sleep hours, limiting caffeine and screen use, organizing the sleep environment, and stress management. The training will be provided by a nurse experienced in sleep health.

Sleep Hygiene Education (Experimental Intervention Arm)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being an associate degree student at Bilecik Şeyh Edebali University School of Health Services.
  • Being a student who has started clinical practice and is actively doing an internship in the clinic.
  • Being between the ages of 18 and 25
  • Scoring ≥ 30 on the Sleep Hygiene Index (UHI) (poor sleep hygiene score)
  • Agreeing to volunteer for the study and signing the informed consent form
  • Not having received any sleep hygiene training in the last 3 months.
  • Being able to participate regularly in the research process (pre-test, training intervention, and post-tests).

You may not qualify if:

  • Having been diagnosed with a sleep disorder (e.g., insomnia, sleep apnea, narcolepsy, etc.).
  • Receiving a diagnosis of a psychiatric illness that can affect mental health and/or taking psychiatric medication regularly.
  • Having a chronic illness and taking regular medication (e.g., diabetes, epilepsy, cardiovascular diseases).
  • Working nite shifts or having irregular sleep schedules (e.g., students on duty).
  • Declaring that they will be unable to regularly participate in the study process or failing to comply with interventions during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep HygieneSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Dilek Gümüş, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Since this study is a single-arm design based on an educational intervention, blinding is not applied to participants or researchers. All students participate in the same training session and fill in their own data. However, during the statistical analysis phase, an independent expert outside of the researcher will work on de-identified (anonymous) data. Thus, the participants' identities will be kept confidential, and the evaluation will be based solely on coded data. No individual names or identifying information will be included in the research reports.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study has a single-arm, pre-post design (allocation: N/A, masking: none). Participants will be selected from among volunteer students in the 2nd-year day programs of the SHMYO. All participants receive two sessions of in-class training (each \~40 minutes; total 80 minutes). The intervention consists of the following components: providing information, increasing awareness, creating an individual sleep plan, and supporting maintenance with short assignments, all within the framework of the Transtheoretical Model. Assessments are performed at T0 (baseline), T1 (2 weeks), and T2 (4 weeks). Primary outcomes: Change in Sleep Hygiene Index and PSQI scores; secondary outcomes: Relationships with Sleep Hygiene Information Test score and lifestyle variables (caffeine, screen time, perceived stress). The analysis is conducted using within-participant comparisons (e.g., paired tests/repeated measures). The aim is to demonstrate the effect of a brief, structured educational model on sleep hygie
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 24, 2025

Study Start

October 30, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share