Virtual Reality Distraction During Arteriovenous Fistula Puncture

The Effect of Virtual Reality Distraction on Pain and Anxiety During Arteriovenous Fistula Puncture Among Hemodialysis Patients: Randomized Controlled Trial

The cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients. Previous studies have shown the effectiveness of virtual reality in reducing pain during needle-related procedures

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Pain Management; Virtual Reality
• Intervention / Treatment: Procedure: virtual reality distraction

Detailed Description

Patients undergoing hemodialysis experience anxiety and pain related to the insertion of hemodialysis needles, estimated 320 times in total per year. The pain experienced is mostly caused by needle insertion into a fistula. Pain control is one of the main nursing tasks. Pain relief leads to the acceptance of the procedure and ultimately enhances the patients' quality of life. The use of virtual reality to reduce pain and anxiety during the arteriovenous fistula cannulation procedure is based on the concept that the perception of pain can be controlled because an individual is able to process only a limited amount of information at once. As such, the use of virtual reality during painful procedures may serve as a distraction.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • faculty of nursing Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who are under- going conventional hemodialysis three times a week
• hemodialysis period of one month or more
• having a healthy AVF access with good function
• welling to participate in study

Exclusion Criteria:

• patients who have psychiatric diseases
• panic disorder, anxiety disorder
• dysfunctional fistula
• vertigo, issues with sight, hearing, or perception
• or use painkillers within three hours before hemodialysis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: study group	Procedure: virtual reality distraction; study group patients will view VR scene for 6 minutes before puncture .It involves a soothing nature experience and calming background music. Patients in intervention group will not able to see the puncture procedure due to the VR glasses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in patients pain scores	visual analogue scale which consists of a vertical line 100 mm long, one end of the line reads "No pain" and at the other is "Unbearable pain	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients anxiety scores	STAI includes two subscales with 20 items each that assess state and trait anxiety .The State Anxiety Scale requires individuals to describe their feelings at a specific moment under specific circumstances, while the Trait Anxiety Scale requires them to describe the way they feel in general.	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in patients satisfaction score	. The patients will be asked to rate procedure satisfaction placing a mark on a 100-mm vertical visual analogue scale	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients heart rate	checklist will be used to assess heart rate after puncture	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients respiratory rate	checklist will be used to assess respiratory rate after puncture	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients systolic blood pressure	checklist will be used to assess systolic blood pressure after puncture	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients diastolic blood pressure	checklist will be used to assess diastolic blood pressure after puncture	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
change in patients Oxygen saturation (SpO2)	checklist will be used to assess Oxygen saturation after puncture	will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

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

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