NCT04711408

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 14, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

January 3, 2021

Last Update Submit

June 13, 2022

Conditions

Chronic PainPelvic PainEndometriosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Virtual reality

EXPERIMENTAL

women allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System

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

Standart care

NO INTERVENTION

women allocated to undergo ultrasound for the diagnosis of endometriosis without VR

Interventions

SootheVR: AppliedVR, Los Angeles, California a head-mounted displaDEVICE

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".

Virtual reality

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.

You may not qualify if:

  • women who reported the use of analgesia 6 hours prior to the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Chronic PainPelvic PainEndometriosis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 15, 2021

Study Start

June 14, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)