- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06458608
Hemodiasis Patients Using Virtual Reality Video
Determining the Effect of Virtual Reality-Based Videos on Hemodialysis Symptoms, Vital Signs and Comfort in Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hemodialysis (HD) is one of the treatment options used to regulate renal functions in the treatment of chronic renal failure. In hemodialysis, patients have to cope with many problems during the treatment process as well as the disease. In addition, patients require HD treatment, which lasts three to four hours, three times a week on average. Factors such as having to go to a dialysis center for these treatments, patients having to continue their lives depending on the machine, restriction of movements during the session, increased dependency of the patient, deterioration in their adaptation to professional and social relationships affect the patients' daily life activities and reduce their comfort. With the developing technology, virtual reality, a new technique in the healthcare industry, has begun to be used in nursing care in order to reduce the symptoms experienced by patients and to comfort the patient.
The virtual reality device removes the patient from the environment with the glasses and headphones attached to the person's head, along with the image on the screen and simultaneous sounds, and focuses his/her attention on the virtual video images. This study was planned as a randomized controlled study to evaluate the effect of virtual reality-based videos on hemodialysis symptoms and comfort in hemodialysis patients. The research was planned to be conducted with 50 hemodialysis patients. "Patient Introduction Form", "Dialysis Symptom Index (DSI)", "Vital Signs Monitoring Form", "Hemodialysis Comfort Scale Version II" will be used to collect data. After the scales were applied, patients in the experimental group were exposed to virtual reality glasses for 30 minutes, twice a week for 8 weeks. The video will be watched. At the end of 8 weeks, the scales will be applied again and compared with the initial scale results.
As a result, in line with the findings obtained from the research, the effect of virtual reality application on dialysis symptoms, vital signs and comfort during hemodialysis treatment will be determined and suggestions will be made to encourage patients to use virtual reality methods in the environments where they are treated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kelkit
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Gümüşhane, Kelkit, Turkey, 2900
- Gümüşhane Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Voluntarily over 18 years
Exclusion Criteria:
- reluctant
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: group that watched virtual reality videos
Pre-test data for all participants before treatment in the waiting room of the hemodialysis unit, "Structured Patient Introduction Form" (Annex-1), "Dialysis Symptom Index (DSI)" (Appendix 2), "Vital Signs Monitoring Form" (Appendix).
3),''Hemodialysis Comfort Scale Version II'' (Appendix 4) face to face interview for approximately 15 minutes is run as learning pre-test data.
The intervention group was also given information about the use of virtual reality and the video content to be watched.
Videos are transferred to virtual reality glasses and presented with the headset.
After the hemodialysis treatment starts, the intervention psychologist researcher will watch 30 scan videos of approximately half an hour during the dialysis period, 2 sessions a week for 8 weeks, and a Turkey promotional short film presented by the researchers visually and audibly in VR (VR Shineco 3d).
|
virtual reality glasses
|
|
Experimental: The group that is not allowed to watch virtual reality videos
The hemodialysis patients in this group were not shown anything.
Only data collection forms were administered to the patients before the study (pretest) and at the end of the study.
|
virtual reality glasses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodialysis Comfort Scale Version II (HDCS Version II)
Time Frame: 8 week
|
The scale consists of a total of 26 items and a 5-point Likert type.
HDCS Version II has six subscales (physical relaxation, physical comfort, psychospiritual comfort, psychospiritual transcendence, environmental transcendence, and sociocultural comfort).
|
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dialysis Symptom Index (DSI) (Appendix 2)
Time Frame: 8 week
|
It consists of a total of 30 items that evaluate the emotional and physical symptoms of dialysis patients and the severity of these symptoms.
|
8 week
|
|
Vital Signs Monitoring Form
Time Frame: 8 week
|
It is a form in which patients' BP, respiratory rate, pulse, temperature and oxygen saturation values are measured and recorded once a week before and after the HD procedure.
|
8 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilan aktepe coşar, Gümüşhane Universıty
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
Other Study ID Numbers
- Hm20240001
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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