Back to resultsRelaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
Primary Purpose
Chronic Kidney Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Relaxation with virtual reality
Attention match
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Diseases
Eligibility Criteria
Inclusion Criteria: Receiving hemodialysis treatment for the last 6 months Receiving four-hour hemodialysis treatment three times a week 18 years or older Deaf and visually impaired Without cognitive and psychiatric diagnosis Open to communication and cooperation Patients who agreed to participate in the study Exclusion Criteria: Kidney transplant Discomfort due to virtual reality glasses Suspected/diagnosed COVID-19 Patients who want to leave the study voluntarily Death
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
The patient will relax with virtual reality in the hemodialysis center with the researcher.
The patients in the control group will be given a training on the functions of the kidneys.
Outcomes
Primary Outcome Measures
Fatigue
In the study, fatigue symptom will be measured with the fatigue severity scale.
Comfort
In the study, hemodialysis comfort will be measured with the hemodialysis comfort scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05814679
Brief Title
Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
Official Title
The Effect of Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 17, 2023 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Based on the task of providing the comfort of the patient, which is an indispensable part of the nursing profession, which many nurse theorists emphasize, there has been no study in the literature on the determination of the effect of virtual relaxation, which can be effective on the fatigue and comfort levels of patients receiving hemodialysis treatment. Therefore, the aim of this study is to examine the effect of virtual reality and relaxation on fatigue and comfort in hemodialysis patients.
Detailed Description
The patient will be prepared for relaxation with virtual reality and will be given a comfortable sitting position.
The patient will watch the relaxation practice with virtual reality once during the hemodialysis treatment.
The application will be terminated with the expiration of the virtual reality relaxation video.
Fatigue and comfort score will be measured after the application.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The patient will relax with virtual reality in the hemodialysis center with the researcher.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The patients in the control group will be given a training on the functions of the kidneys.
Intervention Type
Other
Intervention Name(s)
Relaxation with virtual reality
Intervention Description
In this research, a virtual reality relaxation video will be used in which the natural wonders are presented to the audience in an immersive environment.
Intervention Type
Other
Intervention Name(s)
Attention match
Intervention Description
kidney function instruction
Primary Outcome Measure Information:
Title
Fatigue
Description
In the study, fatigue symptom will be measured with the fatigue severity scale.
Time Frame
Assessing change of fatigue severity scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and fatigue severity scale score will measure fifth week.
Title
Comfort
Description
In the study, hemodialysis comfort will be measured with the hemodialysis comfort scale.
Time Frame
Assessing change of fatigue comfort scale scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and comfort scale score will measure fifth week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving hemodialysis treatment for the last 6 months
Receiving four-hour hemodialysis treatment three times a week
18 years or older
Deaf and visually impaired
Without cognitive and psychiatric diagnosis
Open to communication and cooperation
Patients who agreed to participate in the study
Exclusion Criteria:
Kidney transplant
Discomfort due to virtual reality glasses
Suspected/diagnosed COVID-19
Patients who want to leave the study voluntarily
Death
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
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