Virtual Reality During Ultrasound Examination of Women With Endometriosis

Chronic Pain Clinical Trial

Official title:

Virtual Reality During Ultrasound Examination of Women With Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711408
• Other study ID #: 0602-20-TLV
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Endometriosis
• Pelvic Pain

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