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Virtual Reality Distraction During Arteriovenous Fistula Puncture

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ClinicalTrials.gov Identifier: NCT05399199
Recruitment Status : Completed
First Posted : June 1, 2022
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
mohamed elsayed hamed elzeky, Mansoura University

Study Description
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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

Condition or disease Intervention/treatment Phase
Pain Management Hemodialysis Virtual Reality Procedure: virtual reality distraction Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Virtual Reality Distraction on Pain and Anxiety During Arteriovenous Fistula Puncture Among Hemodialysis Patients: Randomized Controlled Trial
Actual Study Start Date : June 5, 2022
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Fistulas

Arms and Interventions
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Arm Intervention/treatment
Experimental: study group 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.
No Intervention: control group


Outcome Measures
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Primary Outcome Measures :
  1. change in patients pain scores [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    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

  2. change in patients anxiety scores [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    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 :
  1. change in patients satisfaction score [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    . The patients will be asked to rate procedure satisfaction placing a mark on a 100-mm vertical visual analogue scale

  2. change in patients heart rate [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    checklist will be used to assess heart rate after puncture

  3. change in patients respiratory rate [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    checklist will be used to assess respiratory rate after puncture

  4. change in patients systolic blood pressure [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    checklist will be used to assess systolic blood pressure after puncture

  5. change in patients diastolic blood pressure [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    checklist will be used to assess diastolic blood pressure after puncture

  6. change in patients Oxygen saturation (SpO2) [ Time Frame: will be measured at baseline and immediately after intervention (after 6 minutes of VR distraction) ]
    checklist will be used to assess Oxygen saturation after puncture


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05399199


Locations
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Egypt
Faculty of Nursing Mansoura University
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
More Information
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Responsible Party: mohamed elsayed hamed elzeky, lecturer, medical surgical nursing department, faculty of nursing, Mansoura university, Mansoura University
ClinicalTrials.gov Identifier: NCT05399199    
Other Study ID Numbers: mansU
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities