- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07809386
The Effect of Gamified Sleep Hygiene Education on Sleep Quality and Fatigue Levels in Chemotherapy Patients
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Esra Türker, Assoc. Prof.
- Telefonnummer: +905074521224
- E-post: esra.turker@lokmanhekim.edu.tr
Studieorter
-
-
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Ankara, Turkiet (Türkiye)
- Lokman Hekim University Ankara Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Standard Sleep Hygiene Education Group
Participants 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.
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Standard sleep hygiene education will be provided through verbal instruction and educational brochures in two sessions.
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Experimentell: Gamified Sleep Hygiene Education Group
Participants 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
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Richards-Campbell Sleep Questionnaire Total Score
Tidsram: Baseline and immediately after completion of the 2-week intervention
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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.
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Baseline and immediately after completion of the 2-week intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Hirai Cancer Fatigue Scale Total Score
Tidsram: Baseline and immediately after completion of the 2-week intervention
|
Cancer-related fatigue will be measured using the Hirai Cancer Fatigue Scale.
The scale consists of 15 items and yields a total score ranging from 15 to 75, with higher scores indicating greater cancer-related fatigue.
The outcome will be the change in the total score from baseline to the end of the 2-week intervention.
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Baseline and immediately after completion of the 2-week intervention
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025327
- 1919B012551162 (Annat bidrag/finansieringsnummer: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
Plan för individuella deltagardata (IPD)
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