The Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients

NCT05807906 | Completed

• 1 other identifier: E1-22-2882
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Pain-VAS Scale

  VAS Scale is scored from 1 to 10. As the score increases, the severity of pain increases.

  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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.

Other: virtual reality application

Control Group

NO INTERVENTION

Routine nursing care and diet compliance narration

Interventions

virtual reality application OTHER

The patient will continue to monitor the virtual reality application during the fistula puncture procedure.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 11, 2023
• Study Start: April 17, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)