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OpenTrials
Completed

NCT Number: NCT05399199

Virtual Reality Distraction During Arteriovenous Fistula Puncture

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

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Key information

Conditions

Pain Management Agnosia Hemodialysis Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Virtual Reality

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing Mansoura University

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

virtual reality distraction

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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