Skip to main content
OpenTrials
Completed

NCT Number: NCT06150963

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pain (VAS)

    Time frame: 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.

  2. Anxiety (VAS)

    Time frame: 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 outcomes

  1. Pulse Rate (bpm)

    Time frame: 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.

  2. Systolic Blood Pressure (mmHg)

    Time frame: 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.

  3. Diastolic Blood Pressure (mmHg)

    Time frame: 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.

  4. Procedure Length

    Time frame: Duration of procedure

    Procedure length recorded in minutes

  5. Lidocaine Administered

    Time frame: Immediately after procedure

    Quantity of subcutaneous lidocaine administered recorded in milliliters (mL).

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.