Virtual Reality Distraction During Arteriovenous Fistula Puncture

NCT05399199 | Completed

• 1 other identifier: mansU
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Pain Management; Hemodialysis; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• change in patients satisfaction score

  will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

• change in patients heart rate

  will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

• change in patients respiratory rate

  will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

• change in patients systolic blood pressure

  will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

• change in patients diastolic blood pressure

  will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

Study Arms (2)

study group

EXPERIMENTAL

Procedure: virtual reality distraction

control group

NO INTERVENTION

Interventions

virtual reality distraction PROCEDURE

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.

study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Nursing Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, medical surgical nursing department, faculty of nursing, Mansoura university

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: June 1, 2022
• Study Start: June 5, 2022
• Primary Completion: November 30, 2022
• Study Completion: February 15, 2023
• Last Updated: February 21, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)