Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy (VRPAD)

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

Status

Completed

Conditions

Pain, Acute

Anxiety

Treatments

Device: Virtual Reality

Study type

Interventional

Funder types

Other

Identifiers

NCT04721587

IIBSP-VIR-2019-75

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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