The Effect of Gamified Sleep Hygiene Education on Sleep Quality and Fatigue Levels in Chemotherapy Patients
2026年9月2日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
56
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Esra Türker, Assoc. Prof.
- 电话号码：+905074521224
- 邮箱：esra.turker@lokmanhekim.edu.tr
学习地点
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Ankara、土耳其（türkiye）
- Lokman Hekim University Ankara Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Richards-Campbell Sleep Questionnaire Total Score
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Hirai Cancer Fatigue Scale Total Score
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月30日
初级完成 (估计的)
2026年11月1日
研究完成 (估计的)
2026年11月30日
研究注册日期
首次提交
2026年5月29日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 2025327
- 1919B012551162 (其他赠款/资助编号：The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.