- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06863623
The Effect of Immersive Virtual Reality and Relaxing Videos on Lung Cancer Patients
The Effect of Immersive Virtual Reality and Relaxing Videos on Symptom Severity, Distress and Quality of Life in Patients With Lung Cancer Undergoing Chemotherapy
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kadir BAYSOY, PhD (c)
- Phone Number: +905073045536
- Email: kadir.baysoy@gmail.com
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06230
- Recruiting
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- are over 18 years old,
- diagnosed with lung cancer,
- will receive chemotherapy for the first time,
- will receive at least 2 cycles of chemotherapy treatment
- agree to participate in the study,
Exclusion Criteria:
- Having a cognitive and psychiatric disorder and diagnosis,
- Having brain metastasis or chronic disease related to the head-brain region,
- Having vision-hearing problems,
- Having epilepsy, vertigo, chronic severe headache, dizziness problems,
- Having a history of virtual reality, simulator or motion sickness,
- Having/declaring that he/she has open area, underwater, specific animal phobia,
- Do not agree to participate in the study
Study Plan
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 |
|---|---|
|
Experimental: Virtual Reality Group
Immersive Virtual Reality Group: Immersive virtual reality will be applied to this group 2 times during chemotherapy infusion (total of 2 chemotherapy cures) to reduce the symptom severity and distress level and improve the quality of life. For Immersive Virtual Reality interventions; The Meta Quest 2 device will be used and the virtual scenarios/contents were selected from "Nature Treks" app bought by the researcher. (Initially, a total of 6 VR contents and 6 similar videos were created for patients who received cisplatin+etoposide treatment consisting of three sessions of one chemotherapy cure (4 cure, 12 sessions). Due to the limited number of patients and regular attendance to treatment, other similar drug treatments were also included and finally, a total of 2 cures, 2 VR contents and 2 videos were selected and these 2 contents will be used.) These:
|
To apply immersive virtual reality applications (Scenarios)
|
|
Experimental: Relaxing Video Group
Relaxing Video Group: Participants in this group will watch relaxing videos 2 times for 20 min during chemotherapy infusion (total of 2 chemotherapy cures) to reduce the symptom severity and distress level and improve the quality of life. The videos are slideshow-type videos consisting of various images and relaxing music prepared by the researcher. The videos were created by selecting images/sounds similar with the themes/scenarios in the virtual reality application. (Initially, a total of 6 VR contents and 6 similar videos were created for patients who received cisplatin+etoposide treatment consisting of three sessions of one chemotherapy cure (4 cure, 12 sessions). Due to the limited number of patients and regular attendance to treatment, other similar drug treatments were also included and finally, a total of 2 cures, 2 VR contents and 2 videos were selected and these 2 contents will be used.) These:Walking in the Fores and Similar Video Sitting on the Beaach and Similar Video |
To watch relaxing videos including pictures and sounds prepared by researcher
|
|
No Intervention: Control Group
Patients in the control group will receive standard nursing care applied in the chemotherapy unit.
Standard nursing care; Training patients on the method of chemotherapy administration, its duration, content, side effects, and coping, preparing the drugs for administration, preparing the patients for treatment, starting the infusion, monitoring the patients during the infusion for side effects, infusion complications, changes in vital signs, etc. Includes applications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edmonton Symptom Assessment Scale (ESAS)
Time Frame: First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
|
Changes on overall score of Edmonton Symptom Assessment Scale. The scale is a numerical scale between 0 and 10 developed to measure each symptom level (total 12 symptoms). Lower scores indicate lower symptom levels. |
First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
National Comprehensive Cancer Network Distress Thermometer (NCCN-DT)
Time Frame: (Before and after the interventios/for control groups same time -20 mins.-) First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
|
Changes on overall score of Distress Scale. The scale is a numerical scale between 0 and 10 developed to measure stress levels. Lower scores indicate lower stress levels. |
(Before and after the interventios/for control groups same time -20 mins.-) First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
|
|
The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-30)
Time Frame: First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
|
Changes on overall score of Quality of Life Scale. The scale is a multi-dimesion scale including total 30 questios to measure quality of life level. Minimum score is 0, and maximum score is 100. |
First day of each chemotherapy cycle (totally 2 cycles) (2 times in about 21 days, totally 4 times in about 42 days or more)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- KA-22070 (Hacettepe Un.)
- 21-AKD-31 (Registry Identifier: Republic of Turkey Ministry of Health Turkish Medicines and Medical Devices Agency (TİTCK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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