Clinical trial NCT04721587: Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy
Official title: Effectiveness of Virtual Reality as a Pain and Anxiety Distraction Strategy on Office Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anxiety
Keywords: Hysteroscopy
Pain
Virtual Reality
Anxiety
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Psious
First posted: 2021-01-22
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: Intraprocedure
Secondary outcomes:
measure: Heart Rate
timeFrame: Intraprocedure
measure: Blood Pressure
timeFrame: Intraprocedure
measure: Skin conductace
timeFrame: Intraprocedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Josep Estadella Tarriel
role: PRINCIPAL_INVESTIGATOR
References: