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

NCT06150963 | Completed

• 1 other identifier: 27238
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Interventional Radiology; Thyroid Biopsy; Peripherally Inserted Central Catheter; Virtual Reality; Pain; Anxiety; Visual Analog Scale

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Pulse Rate (bpm)

  Three times during procedure

• Systolic Blood Pressure (mmHg)

  Three times during procedure

• Diastolic Blood Pressure (mmHg)

  Three times during procedure

• Procedure Length

  Duration of procedure

• Lidocaine Administered

  Immediately after procedure

Study Arms (4)

Thyroid Biopsy (Control)

ACTIVE COMPARATOR

Patients within this arm received standard procedure thyroid biopsies without virtual reality.

Procedure: Standard Procedure Thyroid Biopsy

Thyroid Biopsy (Virtual Reality)

EXPERIMENTAL

Patients within this arm received standard procedure thyroid biopsies with virtual reality for the length of the procedure.

Device: Virtual Reality; Procedure: Standard Procedure Thyroid Biopsy

PICC (Control)

ACTIVE COMPARATOR

Patients within this arm received standard procedure PICC placements without virtual reality.

Procedure: Standard Procedure PICC Placement

PICC (Virtual Reality)

EXPERIMENTAL

Patients within this arm received standard procedure PICC placements with virtual reality for the length of the procedure.

Device: Virtual Reality; Procedure: Standard Procedure PICC Placement

Interventions

Virtual Reality DEVICE

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.

PICC (Virtual Reality); Thyroid Biopsy (Virtual Reality)

Standard Procedure Thyroid Biopsy PROCEDURE

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.

Thyroid Biopsy (Control); Thyroid Biopsy (Virtual Reality)

Standard Procedure PICC Placement PROCEDURE

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.

PICC (Control); PICC (Virtual Reality)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (2)

• 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.

  PMID: 31308733 RESULT

• 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.

  PMID: 16640481 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Hillel Maresky, M.D.

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 30, 2023
• Study Start: June 10, 2021
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 5 years.
• Access Criteria: Access to trial IPD can be requested by qualified research engaging in independent scientific research, and will be provided following review and approval of a research proposal and a data sharing agreement.

Locations

US (1)