Virtual Reality Glasses and Stress Ball on Distress and Pain Arteriovenous Fistula Cannulation

Effects of Virtual Reality Glasses and Stress Ball on Distress and Pain During Arteriovenous Fistula Cannulation

Effects of Virtual Reality Glasses and Stress Ball on Distress and Pain During Arteriovenous Fistula Cannulation. The research was conducted as a randomized experimental study with a pre-test - post-test control group.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Other: Virtual reality glasses; Other: Stress ball

Detailed Description

Beginning 1-2 minute before the start of the procedure, the patients will be watched (5 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.

A stress ball will be applied to the patient 1-2 minutes before the start of the procedure.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Küçükçekmece, İstanbul, Turkey, 340340
      • Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Be over 18 years old,
• Be able to speak and understand Turkish,
• Have the cognitive ability to answer the data collection tools,
• Be willing to participate in the study,
• Participate in a hemodialysis program three days a week,

Exclusion Criteria:

• Having a communication problem (hearing, language, understanding, etc.),
• Having a psychiatric diagnosis (To be checked from medical records),
• Having failed AVF cannulation at the first attempt,
• Having any signs of infection such as redness, swelling, open wound in the area where the procedure will be performed,
• Having used a sedative within the last 8 hours,
• Having used any painkillers before the procedure on the same day,

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control grups; Routine maintenance will be applied
Experimental: Virtual reality glasses; Virtual reality glasses Beginning 2-3 minute before the start of the procedure, the patients will be watched (5 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product.	Other: Virtual reality glasses; Virtual reality glasses Beginning 2-3 minute before the start of the procedure, the patients will be watched (5 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product.
Experimental: Stress ball; Before AVF cannulation, patients will be given a round, colored, medium-hard, high-quality silicone squeezable ball (the arm without vascular access will be used). In order to avoid implying that the procedure is inherently stressful, patients will be given the name squeeze ball when they are given information about the stress ball application. Patients will be instructed to continue squeezing and relaxing the stress ball (squeezing and relaxing once, counting from one to three) for 5 minutes before and throughout the AVF cannulation procedure. Patients will be instructed to focus their attention on the stress ball and focus on squeezing the stress ball.	Other: Stress ball; Patients will be instructed to continue squeezing and relaxing the stress ball (squeezing and relaxing once, counting from one to three) for 5 minutes before and throughout the AVF cannulation procedure. Patients will be instructed to focus their attention on the stress ball and focus on squeezing the stress ball.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. VAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	Baseline, pre-intervention (Before AVF cannulation procedure)
Visual Analog Scale	The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. VAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.	Immediately after the intervention (After AVF cannulation procedure)
The Distress Thermometer (DT	The Distress Thermometer is a scale developed by Roth et al. (1998) for determining psychological distress in cancer patients. The thermometer is a Likert-type scale with scores from 0 (no stress) to 10 (excessive stress). In a short and easy-tounderstand scale, patients can easily mark their distress levels in ranges indicated on the thermometer. The Turkish validity-reliability study of the Distress Thermometer for cancer patients was performed by Özalp et al. and the recommended cut-off score for the thermometer in this study was set at four and above.	Baseline, pre-intervention (Before AVF cannulation procedure)
The Distress Thermometer (DT	The Distress Thermometer is a scale developed by Roth et al. (1998) for determining psychological distress in cancer patients. The thermometer is a Likert-type scale with scores from 0 (no stress) to 10 (excessive stress). In a short and easy-tounderstand scale, patients can easily mark their distress levels in ranges indicated on the thermometer. The Turkish validity-reliability study of the Distress Thermometer for cancer patients was performed by Özalp et al. and the recommended cut-off score for the thermometer in this study was set at four and above.	Immediately after the intervention (After AVF cannulation procedure)

Collaborators and Investigators

• Sponsor: Istanbul Sabahattin Zaim University
• Investigators: Principal Investigator: Zülfünaz Özer, İstanbul Sabahattin Zaim Üniversitesi

Publications and helpful links

General Publications

• Toraman RL, Eskici Ilgin V. Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial. Biol Res Nurs. 2024 Oct;26(4):485-497. doi: 10.1177/10998004241236154. Epub 2024 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): August 7, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2023/08

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