Clinical trial NCT06150963: Virtual Reality for the Management of Pain and Anxiety for Outpatient Interventional Radiology Procedures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Interventional Radiology
Thyroid Biopsy
Peripherally Inserted Central Catheter
Virtual Reality
Pain
Anxiety
Visual Analog Scale
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain (VAS)
timeFrame: Immediately prior to and after procedure
measure: Anxiety (VAS)
timeFrame: Immediately prior to and after procedure
Secondary outcomes:
measure: Pulse Rate (bpm)
timeFrame: Three times during procedure
measure: Systolic Blood Pressure (mmHg)
timeFrame: Three times during procedure
measure: Diastolic Blood Pressure (mmHg)
timeFrame: Three times during procedure
measure: Procedure Length
timeFrame: Duration of procedure
measure: Lidocaine Administered
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Hillel Maresky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.