Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy

NCT04721587 | Completed DMC

• 1 other identifier: IIBSP-VIR-2019-75
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Pain, Acute; Anxiety

Keywords

Hysteroscopy; Pain; Virtual Reality; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain score

  Decrease of 1 point or more in the level of pain measured by an 11-point visual analog scale, a validity scale that comprises 11 consecutive values from 0 to 10, with "0" corresponding to no pain and "10" to worst pain imaginable.

  Intraprocedure

Secondary Outcomes (3)

• Heart Rate

  Intraprocedure

• Blood Pressure

  Intraprocedure

• Skin conductace

  Intraprocedure

Study Arms (2)

Standard of care

NO INTERVENTION

Office hysteroscopy performed as the standard of care of our Hospital

Virtual Reality

EXPERIMENTAL

Office hysteroscopy with the use of VR environment (preprocedure and during procedure)

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

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

Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years
• Understand and accept the study procedures
• Sign the informed consent.
• Indication of outpatient hysteroscopy according to the care protocols of the center
• Not taking drugs for the treatment of anxiety.

You may not qualify if:

• Not being able to understand the nature of the study and / or the procedures to be followed
• Not signing the informed consent
• Be under the age of 18
• Pregnancy
• Being diagnosed with anxiety disorder or being treated with anxiolytics
• Patients suffering from vertigo
• Patients with epilepsy
• Active ear infection
• Patients with diagnosed hypertension
• Patients with cardiovascular disease
• Patients with psychosis or severe mental illness

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Psious: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Josep Estadella Tarriel

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 22, 2021
• Study Start: February 18, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 20, 2023

Record last verified: 2021-01

Locations

ES (1)