Back to resultsThe Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients
Primary Purpose
Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality application
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Diseases
Eligibility Criteria
Inclusion Criteria: No diagnosis of neuropathic pain No sedatives, analgesics and sedatives are applied 3 hours before the application. Not taking recently taken antipsychotic drugs and tranquilizers, Deaf and visually impaired (to mark VAS pain) 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 Multiple fistula puncture attempts
Sites / Locations
- Ankara City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.
Routine nursing care and diet compliance narration
Outcomes
Primary Outcome Measures
Pain-VAS Scale
VAS Scale is scored from 1 to 10. As the score increases, the severity of pain increases.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05807906
Brief Title
The Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients
Official Title
The Effect of Virtual Reality Application on Fistula Puncture Associated Pain in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 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
The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients.
Hypotheses of the Research:
H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients.
H1-2: Virtual reality application has no effect on fistula puncture-related pain in HD patients.
In the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.
Detailed Description
Demographic/medical data will initially be recorded prior to fistula puncture.
The patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position.
Virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started.
The patient will continue to monitor the virtual reality application during the fistula puncture procedure. It will be ensured that no communication with the patient is made until the application is finished.
The application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine nursing care and diet compliance narration
Intervention Type
Other
Intervention Name(s)
virtual reality application
Intervention Description
The patient will continue to monitor the virtual reality application during the fistula puncture procedure.
Primary Outcome Measure Information:
Title
Pain-VAS Scale
Description
VAS Scale is scored from 1 to 10. As the score increases, the severity of pain increases.
Time Frame
Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain 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:
No diagnosis of neuropathic pain
No sedatives, analgesics and sedatives are applied 3 hours before the application.
Not taking recently taken antipsychotic drugs and tranquilizers,
Deaf and visually impaired (to mark VAS pain)
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
Multiple fistula puncture attempts
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nese Altinok Ersoy, PhD
Phone
+9003125526000
Email
altinokn@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients
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