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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05399199
Other study ID # mansU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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