Clinical trial NCT05399199: Virtual Reality Distraction During Arteriovenous Fistula Puncture
Official title: The Effect of Virtual Reality Distraction on Pain and Anxiety During Arteriovenous Fistula Puncture Among Hemodialysis Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Hemodialysis
Virtual Reality
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in patients pain scores
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
measure: change in patients anxiety scores
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Secondary outcomes:
measure: change in patients satisfaction score
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
measure: change in patients heart rate
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
measure: change in patients respiratory rate
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
measure: change in patients systolic blood pressure
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
measure: change in patients diastolic blood pressure
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
measure: change in patients Oxygen saturation (SpO2)
timeFrame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Nursing Mansoura University
Study officials:
References: