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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04711408
Other study ID # 0602-20-TLV
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 14, 2022
Est. completion date December 1, 2023

Study information

Verified date June 2022
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SootheVR: AppliedVR, Los Angeles, California a head-mounted displa
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".

Locations

Country Name City State
Israel Lis Maternity Hospital, Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 20 minutes
Primary 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. 10 minutes
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