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Completed

NCT Number: NCT06920121

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. The research was conducted as a randomized experimental study with a pre-test - post-test control group.

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Key information

Conditions

Hemodialysis Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Küçükçekmece, Istanbul, 340340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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,

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale

    Time frame: Baseline, pre-intervention (Before AVF cannulation procedure)

    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.

  2. Visual Analog Scale

    Time frame: Immediately after the intervention (After AVF cannulation procedure)

    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.

  3. The Distress Thermometer (DT

    Time frame: Baseline, pre-intervention (Before AVF cannulation procedure)

    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.

  4. The Distress Thermometer (DT

    Time frame: Immediately after the intervention (After AVF cannulation procedure)

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Sabahattin Zaim University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

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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