MedDataX Logo

A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy

NCT ID: NCT04625920

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility Vaginal Blood Loss

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hysteroscopy VR Vurtual reality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual reality

women allocated to undergo hysteroscopy with Vr System

Group Type EXPERIMENTAL

SootheVR: AppliedVR, Los Angeles, California

Intervention Type DEVICE

a head-mounted display

Standart care

women allocated to undergo hysteroscopy without VR

Group Type EXPERIMENTAL

SootheVR: AppliedVR, Los Angeles, California

Intervention Type DEVICE

a head-mounted display

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SootheVR: AppliedVR, Los Angeles, California

a head-mounted display

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

michal roll

Director, Head of Clinical Trails Department, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

eli shprecher, Prof

Role: STUDY_CHAIR

souraski MC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Souraski MC

Tel Aviv, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0793-19

Identifier Type: -

Identifier Source: org_study_id