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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06150963
• Other study ID #: 27238
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: August 2, 2022

Study information

• Verified date: November 2023
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 2, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207. — View Citation

Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VAS)	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.	Immediately prior to and after procedure
Primary	Anxiety (VAS)	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.	Immediately prior to and after procedure
Secondary	Pulse Rate (bpm)	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.	Three times during procedure
Secondary	Systolic Blood Pressure (mmHg)	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.	Three times during procedure
Secondary	Diastolic Blood Pressure (mmHg)	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.	Three times during procedure
Secondary	Procedure Length	Procedure length recorded in minutes	Duration of procedure
Secondary	Lidocaine Administered	Quantity of subcutaneous lidocaine administered recorded in milliliters (mL).	Immediately after procedure