Back to resultsVirtual Reality During Ultrasound Examination of Women With Endometriosis
Primary Purpose
Chronic Pain, Pelvic Pain, Endometriosis
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SootheVR: AppliedVR, Los Angeles, California a head-mounted displa
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.
Exclusion Criteria:
- women who reported the use of analgesia 6 hours prior to the procedure
Sites / Locations
- Lis Maternity Hospital, Tel Aviv Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality
Standart care
Arm Description
women allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System
women allocated to undergo ultrasound for the diagnosis of endometriosis without VR
Outcomes
Primary Outcome Measures
Assessments of pain through pain score parameter
Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety.
Assessments of pain through physiological parameters
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.
Secondary Outcome Measures
Full Information
NCT ID
NCT04711408
First Posted
January 3, 2021
Last Updated
June 13, 2022
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04711408
Brief Title
Virtual Reality During Ultrasound Examination of Women With Endometriosis
Official Title
Virtual Reality During Ultrasound Examination of Women With Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.
Detailed Description
A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pelvic Pain, Endometriosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
women allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System
Arm Title
Standart care
Arm Type
No Intervention
Arm Description
women allocated to undergo ultrasound for the diagnosis of endometriosis without VR
Intervention Type
Device
Intervention Name(s)
SootheVR: AppliedVR, Los Angeles, California a head-mounted displa
Intervention Description
For the study group, virtual reality content will be administered to the participant for the duration of the examination through a head-mounted display, RelieVRTM. The VR content for the trial will be "swimming with dolphins".
Primary Outcome Measure Information:
Title
Assessments of pain through pain score parameter
Description
Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety.
Time Frame
20 minutes
Title
Assessments of pain through physiological parameters
Description
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.
Time Frame
10 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.
Exclusion Criteria:
women who reported the use of analgesia 6 hours prior to the procedure
Facility Information:
Facility Name
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aviad Cohen, MD
Phone
972-547333450
Email
co.aviad@gmail.com
First Name & Middle Initial & Last Name & Degree
eli shprecher, prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality During Ultrasound Examination of Women With Endometriosis
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