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Virtual Reality Distraction During Arteriovenous Fistula Puncture

Primary Purpose

Pain Management, Hemodialysis, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
virtual reality distraction
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain Management

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Nursing Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

study group

control group

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
change in patients heart rate
checklist will be used to assess heart rate after puncture
change in patients respiratory rate
checklist will be used to assess respiratory rate after puncture
change in patients systolic blood pressure
checklist will be used to assess systolic blood pressure after puncture
change in patients diastolic blood pressure
checklist will be used to assess diastolic blood pressure after puncture
change in patients Oxygen saturation (SpO2)
checklist will be used to assess Oxygen saturation after puncture

Full Information

First Posted
May 22, 2022
Last Updated
February 17, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05399199
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management, Hemodialysis, Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
virtual reality distraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in patients pain scores
Description
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
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Title
change in patients anxiety scores
Description
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.
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Secondary Outcome Measure Information:
Title
change in patients satisfaction score
Description
. The patients will be asked to rate procedure satisfaction placing a mark on a 100-mm vertical visual analogue scale
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Title
change in patients heart rate
Description
checklist will be used to assess heart rate after puncture
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Title
change in patients respiratory rate
Description
checklist will be used to assess respiratory rate after puncture
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Title
change in patients systolic blood pressure
Description
checklist will be used to assess systolic blood pressure after puncture
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Title
change in patients diastolic blood pressure
Description
checklist will be used to assess diastolic blood pressure after puncture
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)
Title
change in patients Oxygen saturation (SpO2)
Description
checklist will be used to assess Oxygen saturation after puncture
Time Frame
will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Faculty of Nursing Mansoura University
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Reality Distraction During Arteriovenous Fistula Puncture

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