Back to resultsA Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
Primary Purpose
Infertility, Vaginal Blood Loss
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SootheVR: AppliedVR, Los Angeles, California
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Hysteroscopy, VR, Vurtual reality
Eligibility Criteria
Inclusion Criteria:
- . Women with suspected infection
- women considered not suitable to undergo an office hysteroscopy
- women who reported the use of analgesia 6 hours prior to the procedure.
Exclusion Criteria:
- patient needed office hysteroscopy
Sites / Locations
- Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
- Souraski MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Virtual reality
Standart care
Arm Description
women allocated to undergo hysteroscopy with Vr System
women allocated to undergo hysteroscopy without VR
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04625920
First Posted
October 27, 2020
Last Updated
November 8, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04625920
Brief Title
A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
Official Title
A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
5. Study Description
Brief Summary
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy 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 operative hysteroscopy 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
Infertility, Vaginal Blood Loss
Keywords
Hysteroscopy, VR, Vurtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
women allocated to undergo hysteroscopy with Vr System
Arm Title
Standart care
Arm Type
Experimental
Arm Description
women allocated to undergo hysteroscopy without VR
Intervention Type
Device
Intervention Name(s)
SootheVR: AppliedVR, Los Angeles, California
Intervention Description
a head-mounted display
Primary Outcome Measure Information:
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
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
10 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
. Women with suspected infection
women considered not suitable to undergo an office hysteroscopy
women who reported the use of analgesia 6 hours prior to the procedure.
Exclusion Criteria:
patient needed office hysteroscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eli shprecher, Prof
Organizational Affiliation
souraski MC
Official's Role
Study Chair
Facility Information:
Facility Name
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Souraski MC
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
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