Effect of Virtual Reality on Cannulatio… | Clinical Trial

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

The data were collected by the researcher by using "Descriptive Information Form"

Time frame: The descriptive information form was completed in the patient's room 15-20 minutes before the cannulation procedure.

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.
Visual Analogue Scale

Time frame: 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).

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.
Distress Thermometer

Time frame: Before the Procedure and baseline, after the procedure was completed an average of 5-10 minutes(2st measurement)

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.
Hemodialysis Comfort Scale

Time frame: after the procedure was completed an average of 5-10 minutes

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.

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Official study title

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

Acronym: Hemodialysis

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 15, 2025
Registry last updated: Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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