The Effect of Gamified Sleep Hygiene Education on Sleep Quality and Fatigue Levels in Chemotherapy Patients
2. september 2026 oppdatert av: Esra Turker, Lokman Hekim University
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
56
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Esra Türker, Assoc. Prof.
- Telefonnummer: +905074521224
- E-post: esra.turker@lokmanhekim.edu.tr
Studiesteder
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Ankara, Tyrkia (Türkiye)
- Lokman Hekim University Ankara Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Richards-Campbell Sleep Questionnaire Total Score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Hirai Cancer Fatigue Scale Total Score
Tidsramme: Baseline and immediately after completion of the 2-week intervention
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
1. november 2026
Studiet fullført (Antatt)
30. november 2026
Datoer for studieregistrering
Først innsendt
29. mai 2026
Først innsendt som oppfylte QC-kriteriene
2. september 2026
Først lagt ut (Faktiske)
9. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025327
- 1919B012551162 (Annet stipend/finansieringsnummer: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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