- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07667959
The Effect of Benson Relaxation Exercise Applied to Cancer Patients on Sleep Quality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A sleep hygiene booklet aimed at improving sleep quality in cancer patients was prepared for the control group based on a literature review. The sleep hygiene booklet included the information necessary for achieving quality sleep. An informational booklet on the Benson relaxation exercise was also developed. Care was taken to ensure that both booklets were engaging, easy to read, and written in clear and understandable language. Before printing, a pilot test was conducted by having patients with different educational backgrounds read the booklets. Finally, the booklets were printed and prepared for use during the data collection process.
Patients in both groups were first informed about the study, and written informed consent was obtained. Patients in the control group were initially asked to complete the Patient Identification Form and the PSQI. Following data collection, the control group received education through the sleep hygiene booklet. No further intervention was applied. The data collection process took approximately 5-15 minutes. After 15 days, the PSQI was administered again.
For the experimental group, after completing the Patient Identification Form and the PSQI, patients were given the Benson relaxation exercise booklet, and the exercise was performed together with them. Patients in the experimental group were instructed to practice the Benson relaxation exercise twice daily for 15 days. Accordingly, daily reminders were provided to encourage adherence to the exercise regimen. At the end of the 15-day period, the PSQI was administered again to the intervention group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34450
- Sadi Konuk Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years old
- Given cancer disease
- Don't have any communication problems
Exclusion Criteria:
- Having an illness other than a cancer diagnosis
- Using any narcotic agent that causes sedation
- Using any farmacologic agent for sleep problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Benson relaxation exercise
Benson Relaxation Exercises were developed by Dr. Herbert Benson.
It is a non-pharmacological, non-invasive, and easy-to-learn method that relaxes all muscles.
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Relaxation exercises, developed by Dr. Herbert Benson, are a non-pharmacological, non-invasive, and simple method of learning that relaxes all muscles.
It is emphasized as being the most suitable method in terms of ease of application and learning compared to other relaxation exercises.
This method is used as an effective and reliable way to solve various problems such as controlling stress, relieving pain, improving mood disorders, and enhancing sleep quality.
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Placebo Comparator: Sleep hygiene
A sleep hygiene booklet has been created and provides information about sleep hygiene.
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A booklet on sleep hygiene was created, and training was provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality
Time Frame: 6 months
|
Pittsburgh Sleep Quality Index: The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality and sleep disturbances over the previous month.
It consists of 19 self-rated items that generate seven component scores and a global score, with higher scores indicating poorer sleep quality.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Atlas Uni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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