NCT07190872

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

29 days

First QC Date

September 17, 2025

Last Update Submit

September 16, 2026

Conditions

Keywords

sleep hygienesleep qualitybehavior changetranstheoretical model

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    Baseline to post-intervention assessment after completion of the fourth weekly session (December 24, 2025)

Study Arms (2)

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.

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

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.

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 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilecik Seyh Edebali University, School of Health Services

Bilecik, Bilecik, 11100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep HygieneSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and the researcher delivering the educational intervention were not blinded to group allocation because of the nature of the intervention. Before statistical analysis, the groups were coded as Group 1 and Group 2, and the statistician performed the analyses without knowledge of which coded group represented the intervention or control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
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

November 28, 2025

Study Completion

November 28, 2025

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations