Effect of Virtual Reality on Cannulation-Related Procedural Pain, Distress and Comfort Level in Hemodialysis Patients (Hemodialysis)

Effect of Virtual Reality on Cannulation-Related Procedural Pain, Distress and Comfort Level in Hemodialysis Patients: A Randomized Controlled Study

This study aimed to determine the effects of virtual reality on procedural pain, distress and comfort levels during cannulation in hemodialysis patients.

Study Overview

• Status: Completed
• Conditions: Hemodialysis, Virtual Reality
• Intervention / Treatment: Device: Virtual Reality

Detailed Description

Background Virtual reality is a non-pharmacological method that reduces pain and distress and increases comfort by diverting a patient's attention. This allows individuals to gain self-control and relax during medical procedures.

Purpose: This study aimed to determine the effects of virtual reality on procedural pain, distress and comfort levels during cannulation in hemodialysis patients.

Methods: This randomized controlled study included a total of 52 patients, who were randomly assigned to either the intervention group (n=26) or the control group (n=26). Patients in the intervention group received virtual reality glasses during the procedure in addition to standard routine care, while the control group received standard routine care only. Data were collected using a Descriptive Information Form, the Visual Analogue Scale (VAS), the Distress Thermometer (DT), and the Hemodialysis Comfort Scale. Statistical analysis was performed with the level of significance set at p<0.05.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Health Sciences Faculty , Tarsus University, Mersin, Turkey
    • Mersin, Health Sciences Faculty , Tarsus University, Mersin, Turkey, Turkey (Türkiye), 33400
      • School
  • Tarsus
    • Tarsus, Tarsus, Turkey (Türkiye), 33400
      • Tarsus U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients aged 18 years and older
• who had been receiving hemodialysis treatment via AVF for four-hour sessions three times per week for at least six months
• had a pain score of 0 according to the VAS before the procedure
• were not using any psychiatric medicatio
• voluntarily agreed to participate in the study

Exclusion Criteria:

• Patients were excluded if they had a diagnosed mental health disability,
• language barriers
• were using analgesic drugs within eight hours prior to the hemodialysis session
• a history of epilepsy, vertigo, anxiety, active nausea, vomiting, or headaches
• regular use of painkillers
• chronic pain disorders
• previous experience with virtual reality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; The routine cannulation procedure was applied to the patients in the control group. Apart from this, no additional intervention was implemented. Each patient's pain was evaluated and recorded by a nurse independent of the study during the procedure (1st measurements) with VAS and after the procedure (2st measurements). Similarly, the patient's distress was evaluated with Distress Thermometer and recorded before (1st measurements) and after the procedure (2st measurements) by a nurse independent of the study. HDCS of the patients were evaluated and recorded and immediately after the procedure was completed.
Experimental: Virtual Reality; The intervention utilized VR-SHINECON and headsets, which were cleaned with alcohol-based disinfectant wipes before use for each patient. Patients in the intervention group were offered a choice of various nature, forest, and seaside walk videos with thematic music. The VR intervention commenced approximately three minutes before the cannulation procedure and continued until the procedure was complete. During the procedure, the patient's pain was evaluated and recorded by an independent nurse (referred to as the 1st measurement).Immediately after the procedure was completed, the patient removed the VR glasses. The Visual analogue scale, DT and Hemodialysis Comfort Scale were then assessed and recorded by the independent nurse (referred to as the 2nd measurements).	Device: Virtual Reality; The intervention utilized VR-SHINECON and headsets, which were cleaned with alcohol-based disinfectant wipes before use for each patient (Figure 1). Patients in the intervention group were offered a choice of various nature, forest, and seaside walk videos with thematic music. The VR intervention commenced approximately three minutes before the cannulation procedure (immediately following the baseline assessment) and continued until the procedure was complete (approx. 5-10 minutes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The data were collected by the researcher by using "Descriptive Information Form"	Descriptive information form This form prepared by the researchers after reviewing relevant literature (18,21), this semi-structured form includes 12 questions focusing on the socio-demographic and medical information of the participants.	The descriptive information form was completed in the patient's room 15-20 minutes before the cannulation procedure.
Visual Analogue Scale	This scale (VAS), originally developed by Price et al.22 and validated in Turkish for postoperative pain assessment by Eti Aslan 23, was used to quantify pain intensity. The scale consists of a 10-cm horizontal line anchored by the descriptors "no pain" and "worst imaginable pain". Participants marked their perceived pain level on the line, and the score was recorded in centimeters. Written permission for the Turkish version was secured from Eti Aslan. All VAS measurements were recorded by an independent nurse who was not involved in the intervention.	During the procedure, the patient's pain was evaluated and recorded by an independent nurse (referred to as the 1st measurement). Immediately after the procedure was completed, after an average of 1-2 minutes (VAS were then assessed (2st measurement).
Distress Thermometer	The Distress Thermometer was first developed by Roth and colleagues for use in identifying non-pathological distress in patients undergoing cancer treatment after answering the necessary questions. The distress level is rated from 0 to 10. The practitioner expresses the distress experienced using the numbers on the thermometer. A score of zero indicates no distress, while a score of 10 indicates the highest level of distress. The green zone encompasses scores from 0 to 3. Individuals experiencing distress within this range are capable of managing their distress. The yellow zone encompasses scores from 4 to 6. A distress score in this range indicates that the individual is unable to manage their distress and requires intervention to return them to the green zone. The red zone encompasses scores from 7 to 10. Individuals experiencing distress within this range require urgent and comprehensive intervention.	Before the Procedure and baseline, after the procedure was completed an average of 5-10 minutes(2st measurement)
Hemodialysis Comfort Scale	This scale developed by Şahin Orak et al., is a reliable, nine-item, five-point Likert-type instrument used to assess comfort in patients receiving hemodialysis for at least six months.29 It consists of two subscales: 'Relaxation' and 'Coping.' Items are scored from 1 to 5 with Item 4 being reverse-scored. Total scores range from 9.00 to 45.00, where higher scores indicate greater comfort. Subscale ranges are 3.00-15.00 for Relaxation and 7.00-30.00 for Coping. The scale demonstrated strong reliability, with a Cronbach's alpha of 0.87 in the original Turkish validation study, and 0.80 in the present study.	after the procedure was completed an average of 5-10 minutes

Collaborators and Investigators

• Sponsor: Tarsus University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): December 25, 2025
• Study Completion (Actual): December 25, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Arteriovenous fistula; Virtual reality; Hemodialysis; Distress; Cannulation; Procedural pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Arteriovenous Fistula
• Other Study ID Numbers: 2024/106

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