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

NCT07281144 | Completed DMC

• 1 other identifier: 2024/106
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hemodialysis, Virtual Reality

Keywords

Arteriovenous fistula; Cannulation; Distress; Hemodialysis; Procedural pain; Virtual reality

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

control group

NO INTERVENTION

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.

Virtual Reality

EXPERIMENTAL

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

Interventions

Virtual Reality DEVICE

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).

Virtual Reality

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (2)

School

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

Location

Tarsus U

Tarsus, Tarsus, 33400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Pain, Procedural

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 15, 2025
• Study Start: November 1, 2024
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)