Virtual Reality Distraction During Arteriovenous Fistula Puncture

• Sponsor: Mansoura University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05399199
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.3
• Patients Per Site Per Month: 14.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Management; Hemodialysis; Virtual Reality	Procedure: virtual reality distraction	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Virtual Reality Distraction on Pain and Anxiety During Arteriovenous Fistula Puncture Among Hemodialysis Patients: Randomized Controlled Trial
• Actual Study Start Date: Jun 5, 2022
• Anticipated Primary Completion Date: Sep 15, 2022
• Anticipated Study Completion Date: Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group	Procedure: virtual reality distraction; study group patients will view VR scene for 15 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.
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. change in patients pain scores [will be measured at baseline and immediately after intervention (after 15 minutes of VR distraction)]

   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

2. change in patients anxiety scores [will be measured at baseline and immediately after intervention (after 15 minutes of VR distraction)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Nursing Mansoura University	Mansoura		Egypt

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mohamed elsayed hamed elzeky, lecturer, medical surgical nursing department, faculty of nursing, Mansoura university, Mansoura University
• ClinicalTrials.gov Identifier: NCT05399199
• Other Study ID Numbers: mansU
• First Posted: Jun 1, 2022
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arteriovenous Fistula; Fistula

Study Results

No Results Posted as of Jun 8, 2022