- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07798661
Laughter Yoga- Integrated Virtual Reality Nature Exploration in Early Stage of Chemotherapy
August 28, 2026 updated by: Yasemin Ciraci Yasar, Ataturk University
The Effect of Laughter Yoga- Integrated Virtual Reality Nature Exploration on Anxiety and Insomnia of Patients in Early Stage of Chemotherapy
After obtaining informed consent, pre-test applications will be performed on participants in the experimental and control groups following randomization, and information regarding treatment plans will be recorded.
Patients in the experimental group will receive laughter yoga practice integrated with virtual reality videos during chemotherapy infusion.
The practice is planned to be once a week for four weeks.
High-resolution, adjustable virtual reality glasses with head and hand tracking features will be used for the virtual reality application.
The videos will consist of relaxing content such as nature walks, beach and sea views, and will be prepared in three-dimensional, 360-degree viewing angles integrated with laughter yoga exercises.
Personalized video content will be created according to the participants' preferences, and the viewing time will be limited to 10 minutes for each application.
After the completion of the fourth course, data collection tools will be re-administered for post-testing purposes.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yasemin Ciraci, Assist. Prof.
- Phone Number: 00904422311448
- Email: yaseminciraci90@gmail.com
Study Locations
-
-
YAKUTİYE
-
Erzurum, YAKUTİYE, Turkey (Türkiye), 25240
- Atatürk University Faculty of Nursing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
≥18 years of age, being in the early stage of chemotherapy, no surgical treatment plan, voluntary participation.
Exclusion Criteria:
psychiatric disorder, treatments other than chemotherapy, not in the early stage of chemotherapy vision and hearing problems, planned surgical procedure, skin/eye infections that would prevent the use of virtual reality, previous laughter yoga experience.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
|
|
|
Experimental: interviention
laughter yoga-integrated Vİrtual Reality
|
A digital-based behavioral approach for symptom control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Time Frame: 4 week
|
This self-report scale, used to assess sleep quality and sleep-related problems, consists of seven components.
The scale was first developed by Buysse et al. in 1989, and studies have shown that it has sufficient internal consistency (Cronbach's alpha=0.80),
test-retest reliability, and construct validity.
The Turkish validity and reliability study of the scale was carried out by Ağargün et al., and it was shown that it can be used in the Turkish population.
|
4 week
|
|
State-Trait Anxiety Inventory (STAI)
Time Frame: 4 week
|
Developed by Spielberger et al. and adapted into Turkish by Öner and Le Compte, this inventory assesses anxiety levels.
It includes two subscales, each consisting of 20 items, measuring the individual's immediate anxiety level and general anxiety tendency separately.
The scale is evaluated on a four-point Likert scale, with scores ranging from 20 to 80, indicating a higher level of anxiety.
|
4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
March 30, 2027
Study Registration Dates
First Submitted
August 28, 2026
First Submitted That Met QC Criteria
August 28, 2026
First Posted (Actual)
September 1, 2026
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 28, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATATURKU-NRS-16884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.