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

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Procedure: Standard Procedure Thyroid Biopsy; Device: Virtual Reality; Procedure: Standard Procedure PICC Placement

• Registration Number: NCT06150963
• Lead Sponsor: Temple University

Brief 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.

Study Timeline

• Study Start: 2021-06-10
• Primary Completion: 2022-08-02
• Study Completion: 2022-08-02
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Age over 18
• Scheduled to receive Fine-Needle Aspiration (FNA) Thyroid Biopsy
• Scheduled to receive Peripherally Inserted Central Catheters (PICC)

Exclusion Criteria

• Declining to participate
• Inability to provide consent
• Emergency procedures
• Administration of general anesthesia/moderate sedation
• Visual or hearing deficits
• Pregnancy
• Current prisoner status
• Nerve or sensory deficits over area of procedure
• COVID-19 positive status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thyroid Biopsy (Control)	Standard Procedure Thyroid Biopsy	Patients within this arm received standard procedure thyroid biopsies without virtual reality.
Thyroid Biopsy (Virtual Reality)	Virtual Reality	Patients within this arm received standard procedure thyroid biopsies with virtual reality for the length of the procedure.
Thyroid Biopsy (Virtual Reality)	Standard Procedure Thyroid Biopsy	Patients within this arm received standard procedure thyroid biopsies with virtual reality for the length of the procedure.
PICC (Virtual Reality)	Virtual Reality	Patients within this arm received standard procedure PICC placements with virtual reality for the length of the procedure.
PICC (Virtual Reality)	Standard Procedure PICC Placement	Patients within this arm received standard procedure PICC placements with virtual reality for the length of the procedure.
PICC (Control)	Standard Procedure PICC Placement	Patients within this arm received standard procedure PICC placements without virtual reality.

Primary Outcome Measures

Name	Time	Method
Pain (VAS)	Immediately prior to and after procedure	Pre-procedure pain assessments were obtained using a Visual Analog Scale (VAS) corresponding to the patient's expected level of pain during each procedure prior to randomization to treatment or control. VAS scale was measured in mm, 0mm indicating "no pain", 100mm indicating "worst pain." Following each procedure, participants completed a self-reported survey indicating actual pain felt during procedure on VAS scale.
Anxiety (VAS)	Immediately prior to and after procedure	Pre-procedure anxiety assessments were administered using a VAS scale to indicate the patient's level of anxiety prior to randomization to treatment or control. Similar to pain, VAS anxiety scale was measured in mm, 0mm indicating "no anxiety", 100mm indicating "worst anxiety." Following each procedure, participants completed a self-reported survey indicating actual level anxiety experienced during the procedure on VAS scale.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure (mmHg)	Three times during procedure	Diastolic blood pressure was collected at three points during each trial: immediately after headset placement, six minutes into each procedure, and immediately following completion of the procedure.
Lidocaine Administered	Immediately after procedure	Quantity of subcutaneous lidocaine administered recorded in milliliters (mL).
Procedure Length	Duration of procedure	Procedure length recorded in minutes
Systolic Blood Pressure (mmHg)	Three times during procedure	Systolic blood pressure was collected at three points during each trial: immediately after headset placement, six minutes into each procedure, and immediately following completion of the procedure.
Pulse Rate (bpm)	Three times during procedure	Pulse rate was monitored and collected at three points during each trial: immediately after headset placement, six minutes into the procedure, and immediately following completion of the procedure.

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States