NCT06150963

Virtual Reality for the Management of Pain and Anxiety for Outpatient Interventional Radiology Procedures

Virtual Reality for the Management of Pain and Anxiety for Outpatient Interventional Radiology Procedures Performed With Local Anesthesia: A Randomized Pilot Study in Digital Sedation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study explores the use of virtual reality (VR) to reduce pain and anxiety during thyroid biopsies and PICC line insertions under local anesthesia. One group experienced the procedure with VR, while the other group did not. Participants completed questionnaires before and after the surgery to measure pain and anxiety levels. The main goal is to observe if VR can significantly decrease pain and anxiety during these procedures.

Detailed description

This prospective, randomized, controlled study investigates the efficacy of virtual reality (VR) as a means to alleviate pain and anxiety in individuals receiving thyroid biopsies and PICC placements with local anesthesia. This study was conducted at Temple University Hospital between June 2021 and August 2022. A total of 107 patients were randomized into treatment and control groups. The VR experience involved wearing a headset with an immersive 3D visual display and accompanying music, simulating a calming environment. Patients completed Visual Analog Scales for pain and anxiety both before and after the intervention, reflecting their pain and anxiety levels prior to and during the procedure. The primary endpoints were to observe the effect of VR on pain and anxiety in both groups.

Conditions

• Pain
• Anxiety

Interventions

Type	Name	Description
DEVICE	Virtual Reality	Study participants assigned to the VR intervention group were fitted with an HP Reverb G2 Head Mounted Display (HMD) and a wireless mouse prior to preparation for procedure. One virtual environment was utilized, integrating passive and active participant input via gyroscopic motion detection and computer mouse input.
PROCEDURE	Standard Procedure Thyroid Biopsy	In this procedure the patient lies down on a bed with their neck tilted back to reveal the thyroid gland. The doctor cleans the skin over the nodule and numbs it with a local anesthetic. The doctor will then use an ultrasound device to visualize the nodule and guide a needle to obtain cells through the syringe. This process may be repeated several times to retrieve adequate tissue for analysis.
PROCEDURE	Standard Procedure PICC Placement	In this procedure the patient lies down on a bed and has their arm cleaned and then numbed with a local anesthetic. The doctor then uses an ultrasound to locate a suitable vein in the arm, typically above the elbow. The physician then makes a small incision in the skin and inserts a needle into the vein, followed by guidance of the Peripherally Inserted Central Catheter (PICC) through the needle until it reaches a large vein near the heart. The final position is confirmed by X-ray and the PICC line is secured at the site of insertion.

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2023-11-30
• Last updated: 2023-11-30

Locations

1 site across 1 country: United States