The Effect of Gamified Sleep Hygiene Education on Sleep Quality and Fatigue Levels in Chemotherapy Patients
2 other identifiers
interventional
56
1 country
1
Brief Summary
Sleep disturbances and fatigue are common problems among patients receiving chemotherapy and may negatively affect their quality of life. This randomized controlled trial aims to evaluate the effect of gamified sleep hygiene education on sleep quality and cancer-related fatigue in patients receiving chemotherapy. A total of 56 patients will be randomly assigned to two groups, with 28 participants in each group. The intervention group will receive gamified sleep hygiene education through the web-based "Sleep Hunter" program, while the active comparator group will receive standard sleep hygiene education through verbal instruction and educational brochures. The intervention will be delivered in two sessions over a two-week period. Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire, and cancer-related fatigue will be assessed using the Hirai Cancer Fatigue Scale. Outcomes will be assessed at baseline and after completion of the two-week intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Sep 2026
Shorter than P25 for not_applicable cancer
1 active site
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
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
September 9, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
September 9, 2026
September 1, 2026
1 month
May 29, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Richards-Campbell Sleep Questionnaire Total Score
Sleep quality will be measured using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ yields a total score ranging from 0 to 100, with higher scores indicating better perceived sleep quality. The outcome will be the change in the RCSQ total score from baseline to the end of the 2-week intervention.
Baseline and immediately after completion of the 2-week intervention
Secondary Outcomes (1)
Change in Hirai Cancer Fatigue Scale Total Score
Baseline and immediately after completion of the 2-week intervention
Study Arms (2)
Standard Sleep Hygiene Education Group
ACTIVE COMPARATORParticipants in the control group will receive standard sleep hygiene education through verbal instruction and educational brochures in two sessions. Post-intervention assessments will be performed following completion of the education.
Gamified Sleep Hygiene Education Group
EXPERIMENTALParticipants in the intervention group will receive gamified sleep hygiene education using the web-based "Sleep Hunter" educational material. The intervention will be delivered over a two-week period. The gamified education includes sleep hygiene content presented through an online escape-room format incorporating educational videos, audio narrations, visuals, animations, matching activities, fill-in-the-blank activities, and true/false questions
Interventions
Standard sleep hygiene education will be provided through verbal instruction and educational brochures in two sessions.
Gamified sleep hygiene education will be delivered using the web-based "Sleep Hunter" educational material developed in an online escape-room format. The educational content includes sleep hygiene, stimulus control, caffeine use, screen light exposure, regulation of the sleep environment, relaxation exercises, breathing techniques, and establishment of a sleep routine. The program incorporates gamification elements including badges, levels, rewards, educational videos, audio narrations, visuals, animations, matching activities, fill-in-the-blank activities, and true/false questions. The intervention will be delivered using smartphones or tablets in two sessions over a two-week period. Each session will last no longer than 10 minutes, with a total education duration of approximately 20 minutes.
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
- Currently receiving chemotherapy
- Able to read and write in Turkish
- Able to communicate effectively
- Able to use a smartphone or tablet and access the web-based educational intervention
- No previous diagnosis of a sleep disorder
- No previous treatment for a sleep disorder
- Voluntary participation in the study
You may not qualify if:
- Presence of a major mental disorder that may interfere with participation in the study
- Presence of a major visual, hearing, or communication impairment that may interfere with participation in the study
- Unable to read or write in Turkish
- Unable to use a smartphone or tablet or access the web-based educational intervention
- Previous diagnosis of a sleep disorder
- Previous treatment for a sleep disorder
- Unwilling to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lokman Hekim University Ankara Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 29, 2026
First Posted
September 9, 2026
Study Start
September 30, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
September 9, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be publicly shared to protect participant confidentiality and privacy. Aggregated study results will be reported in scientific publications and presentations.