PainNCT06150963
Virtual Reality for the Management of Pain and Anxiety for Outpatient Interventional Radiology Procedures
A study testing Virtual Reality, Standard Procedure Thyroid Biopsy and Standard Procedure PICC Placement in people with Pain and Anxiety, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Virtual Reality, Standard Procedure Thyroid Biopsy and Standard Procedure PICC Placement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18
- Scheduled to receive Fine-Needle Aspiration (FNA) Thyroid Biopsy
- Scheduled to receive Peripherally Inserted Central Catheters (PICC)
Who cannot join
- Declining to participate
- Inability to provide consent
- Emergency procedures
- Administration of general anesthesia/moderate sedation
- Visual or hearing deficits
- Pregnancy
Show all 9Show fewer
- Current prisoner status
- Nerve or sensory deficits over area of procedure
- COVID-19 positive status
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
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
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.
Read the 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.
- Being tested
- Virtual Reality, Standard Procedure Thyroid Biopsy, Standard Procedure PICC Placement
- Keywords
- Interventional Radiology, Thyroid Biopsy, Peripherally Inserted Central Catheter, Virtual Reality, Pain, Anxiety, Visual Analog Scale
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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 BiopsyProcedure or surgery
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 PlacementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Biopsy (Control) | Active comparator | Patients within this arm received standard procedure thyroid biopsies without virtual reality. Receives: 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. Receives: Device: Virtual Reality; Procedure: Standard Procedure Thyroid Biopsy |
| PICC (Control) | Active comparator | Patients within this arm received standard procedure PICC placements without virtual reality. Receives: 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. Receives: Device: Virtual Reality; Procedure: Standard Procedure PICC Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately prior to and after procedure
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Three times during procedure
Procedure Length
Procedure length recorded in minutes
Measured: Duration of procedure
Lidocaine Administered
Quantity of subcutaneous lidocaine administered recorded in milliliters (mL).
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start10 Jun 2021
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hillel Maresky, M.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150963
- Sponsor's protocol ID
- 27238
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie the results reported in the main publication, including demographics, outcomes, and adverse events, will be shared.
Publications
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.
PubMed 31308733Gold 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.
PubMed 16640481
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06150963
- Acronym / sponsor ID
- 27238
- Keywords
- Interventional Radiology, Thyroid Biopsy, Peripherally Inserted Central Catheter, Virtual Reality, Pain, Anxiety, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Thyroid Biopsy (Control) | Active comparator | Procedure: Standard Procedure Thyroid BiopsyPatients within this arm received standard procedure thyroid biopsies without virtual reality. |
| Thyroid Biopsy (Virtual Reality) | Experimental | Device: Virtual Reality, Procedure: Standard Procedure Thyroid BiopsyPatients within this arm received standard procedure thyroid biopsies with virtual reality for the length of the procedure. |
| PICC (Control) | Active comparator | Procedure: Standard Procedure PICC PlacementPatients within this arm received standard procedure PICC placements without virtual reality. |
| PICC (Virtual Reality) | Experimental | Device: Virtual Reality, Procedure: Standard Procedure PICC PlacementPatients within this arm received standard procedure PICC placements with virtual reality for the length of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18
- Scheduled to receive Fine-Needle Aspiration (FNA) Thyroid Biopsy
- Scheduled to receive Peripherally Inserted Central Catheters (PICC)
Key exclusion criteria (9 listed)
- Declining to participate
- Inability to provide consent
- Emergency procedures
- Administration of general anesthesia/moderate sedation
- Visual or hearing deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityStudy 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. | Device | PICC (Virtual Reality), Thyroid Biopsy (Virtual Reality) |
| Standard Procedure Thyroid BiopsyIn 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. | Procedure or surgery | Thyroid Biopsy (Control), Thyroid Biopsy (Virtual Reality) |
| Standard Procedure PICC PlacementIn 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. | Procedure or surgery | PICC (Control), PICC (Virtual Reality) |
Primary outcome
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.
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.
5 secondary outcomes
Pulse Rate (bpm)
Time frame: Three times during procedure
Systolic Blood Pressure (mmHg)
Time frame: Three times during procedure
Diastolic Blood Pressure (mmHg)
Time frame: Three times during procedure
Procedure Length
Time frame: Duration of procedure
Lidocaine Administered
Time frame: Immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Results publication: PubMed 31308733Mallari 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.
- Results publication: PubMed 16640481Gold 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie the results reported in the main publication, including demographics, outcomes, and adverse events, will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillel Maresky, M.D. principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality, Standard Procedure Thyroid Biopsy and Standard Procedure PICC Placement in people with Pain and Anxiety, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VAS) (time frame: Immediately prior to and after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06150963, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.