- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05814679
Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
February 27, 2024 updated by: Neşe Altinok Ersoy, Hacettepe University
The Effect of Relaxation With Virtual Reality on Fatigue and Comfort in Hemodialysis Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
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 Locations
-
-
-
Ankara, Turkey, 06100
- Ankara Cit Hospital
-
-
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:
- 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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
The patient will relax with virtual reality in the hemodialysis center with the researcher.
|
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.
|
Placebo Comparator: Control Group
The patients in the control group will be given a training on the functions of the kidneys.
|
kidney function instruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
In the study, fatigue symptom will be measured with the fatigue severity scale.
|
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.
|
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.
|
In the study, hemodialysis comfort will be measured with the hemodialysis comfort scale.
|
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.
|
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 (Actual)
May 31, 2023
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
March 7, 2023
First Submitted That Met QC Criteria
April 3, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1-22-3047
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.
Clinical Trials on Chronic Kidney Diseases
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
Clinical Trials on Relaxation with virtual reality
-
Istituto Auxologico ItalianoCompletedGeneralized Anxiety DisorderItaly
-
Assistance Publique Hopitaux De MarseilleCompletedGeneralized Anxiety DisordersFrance
-
King's College LondonCompletedStress, Psychological | Psychological Burnout | Mental Health BurdenUnited Kingdom
-
University of TurkuCity of Helsinki; University of Dundee; University of St AndrewsCompleted
-
State Budgetary Healthcare Institution, National...CompletedThe Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.Aphasia | Virtual Reality | Emotional DisturbancesRussian Federation
-
Thomas More University of Applied SciencesUniversitair Ziekenhuis Brussel; Algemeen Ziekenhuis Sint_MaartenCompletedPain | Stress | AnxietyBelgium
-
University of Missouri-ColumbiaCompletedPain, Chronic | Insomnia ChronicUnited States
-
Spaulding Rehabilitation HospitalCompletedChronic Low Back PainUnited States
-
Rennes University HospitalEquipe Hybrid, INRIA - Campus Universitaire de Beaulieu - F-35042 Rennes...Recruiting
-
Ataturk UniversityCompletedVirtual Reality | Bronchoscopy | Relaxation Program | GlassesTurkey