Virtual Reality for the Management of Pain and Anxiety for Outpatient Interventional Radiology Procedures
NCT ID: NCT06150963
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2021-06-10
2022-08-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Thyroid Biopsy (Control)
Patients within this arm received standard procedure thyroid biopsies without virtual reality.
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.
Thyroid Biopsy (Virtual Reality)
Patients within this arm received standard procedure thyroid biopsies with virtual reality for the length of the procedure.
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.
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.
PICC (Control)
Patients within this arm received standard procedure PICC placements without virtual reality.
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.
PICC (Virtual Reality)
Patients within this arm received standard procedure PICC placements with virtual reality for the length of the procedure.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to receive Fine-Needle Aspiration (FNA) Thyroid Biopsy
* Scheduled to receive Peripherally Inserted Central Catheters (PICC)
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Temple University
OTHER
Responsible Party
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Principal Investigators
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Hillel Maresky, M.D.
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
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Temple University Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
Other Identifiers
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27238
Identifier Type: -
Identifier Source: org_study_id