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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Device: Virtual Reality
* Procedure: Standard Procedure Thyroid Biopsy
* Procedure: Standard Procedure PICC Placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thyroid Biopsy (Control)<br>Patients within this arm received standard procedure thyroid biopsies without virtual reality. | Procedure: Standard Procedure Thyroid Biopsy<br>* 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.<br>|
| Experimental: Thyroid Biopsy (Virtual Reality)<br>Patients within this arm received standard procedure thyroid biopsies with virtual reality for the length of the procedure. | Device: Virtual Reality<br>* 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.<br>Procedure: Standard Procedure Thyroid Biopsy<br>* 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.<br>|
| Active Comparator: PICC (Control)<br>Patients within this arm received standard procedure PICC placements without virtual reality. | Procedure: Standard Procedure PICC Placement<br>* 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.<br>|
| Experimental: PICC (Virtual Reality)<br>Patients within this arm received standard procedure PICC placements with virtual reality for the length of the procedure. | Device: Virtual Reality<br>* 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.<br>Procedure: Standard Procedure PICC Placement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Procedure Length | Procedure length recorded in minutes | Duration of procedure | 
| Lidocaine Administered | Quantity of subcutaneous lidocaine administered recorded in milliliters (mL). | Immediately after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interventional Radiology, Thyroid Biopsy, Peripherally Inserted Central Catheter, Virtual Reality, Pain, Anxiety, Visual Analog Scale