Virtual Reality's Role in See&Treat Hysteroscopy

NCT ID: NCT06524934

Last Updated: 2024-07-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-16

Study Completion Date

2024-07-15

Brief Summary

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The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \& treat philosophy.

Detailed Description

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Conditions

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Endometrial Cancer Endometrial Diseases Myoma;Uterus Endometrial Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Case group

The patients in this group undergo the procedure using virtual reality.

Group Type EXPERIMENTAL

Use of virtual reality during the hysteroscopic procedure

Intervention Type DEVICE

In VR group patients underwent hysteroscopy with standard care but the addition of VRT provided by a VR headset and headphones with the use of a Hypno VR software.

Control group

The patients in this group undergo the procedure without the use of virtual reality.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of virtual reality during the hysteroscopic procedure

In VR group patients underwent hysteroscopy with standard care but the addition of VRT provided by a VR headset and headphones with the use of a Hypno VR software.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Brunella Zizolfi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brunella Ms Zizolfi, AssProfessor

Role: PRINCIPAL_INVESTIGATOR

University Federico II of Naples - Italy

Locations

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University of Naples Federico II

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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112/24

Identifier Type: -

Identifier Source: org_study_id

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