Virtual Reality Distraction During Arteriovenous Fistula Puncture

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399199
• Other study ID #: mansU
• Status: Completed
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: October 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 15, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Hemodialysis
• Pain Management
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Nursing Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)