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

NCT06920121 | Completed

• 1 other identifier: 2023/08
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (3)

Virtual reality glasses

EXPERIMENTAL

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

Stress ball

EXPERIMENTAL

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

Control grups

NO INTERVENTION

Routine maintenance will be applied

Interventions

Virtual reality glasses OTHER

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.

Virtual reality glasses

Stress ball OTHER

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.

Stress ball

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Küçükçekmece, Istanbul, 340340, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38418943 RESULT

Study Officials

• Zülfünaz Özer

  İstanbul Sabahattin Zaim Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: August 5, 2024
• Primary Completion: August 7, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)