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Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy

NCT04721587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-12-20

No results posted yet for this study

Summary

Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. The "see and treat" strategy allows diagnosis and treatment in the same surgical act, and gives the technique a high resolution capacity, reducing the number of procedures the patient must undergo. The technological development of instruments has made it possible to have small-caliber endoscopic systems that have made this technique possible in an outpatient setting. Outpatient management allows patients to avoid the possible risks and inconveniences associated with the surgical environment, such as the waiting list and the need for anesthesia, as well as an earlier return to their activities of daily life. Despite the high resolution rates, a not inconsiderable percentage of women experience anxiety or pain during outpatient hysteroscopy, and this is the leading cause of treatment failure. In order to improve the tolerance and comfort of the patient, the usefulness of various strategies, both pharmacological and non-pharmacological, has been evaluated for pain reduction, with different results.

Virtual Reality (VR) has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental processes, chronic pruritus or venipuncture. There is no published study to our knowledge that evaluates the usefulness of VR in reducing the levels of anxiety and pain perceived during a hysteroscopic procedure.

The working hypothesis to be evaluated with this study is that the use of a VR device with reproduction of relaxing and distraction environments reduces the perception of pain and anxiety of the patient during an outpatient hysteroscopy.

Conditions

Interventions

DEVICE

Virtual Reality

The patients of the VR Group will be subjected to the same hysteroscopy technique as the Standard of Care Group, but additionally a VR device will be applied where a distraction VR environment ("Underwater Game") will be reproduced during the exploration

Sponsors & Collaborators

  • Psious

    collaborator UNKNOWN

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Josep Estadella Tarriel · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04721587 on ClinicalTrials.gov