NCT03827824: Hysteroscopy

Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy

Terminated NA Last updated 19 May 2023

What this trial tests

NA trial testing Hysteroscopy & virtual reality glasses in Uterine Diseases in 154 participants. Terminated before completion.

Timeline

30 March 2019

Primary endpoint
30 October 2019

31 December 2020

Quick facts

Lead sponsor	Universidad Francisco de Vitoria
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	154
Start date	30 March 2019
Primary completion	30 October 2019
Estimated completion	31 December 2020
Sites	1 location across Spain

Drugs / interventions tested

• Hysteroscopy & virtual reality glasses
• Hysteroscopy

Conditions studied

• Uterine Diseases — all drugs for Uterine Diseases →

Sponsor

Universidad Francisco de Vitoria — full company profile →

Who can join

Adults 18 to 75, female only, with Uterine Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized intervention trial with a calculated sample size of 90 women aged between 18 and 75 years and medical criteria for performing a diagnostic hysteroscopy according to the Gynecology and Obstetrics Spanish Society (SEGO).

Nowadays the investigators known that acute pain requires cognitive attention for its perception, a patient's state of anxiety depends on the subjective capacity to cope with the process and that environments created with virtual reality can cause a cognitive distraction that diminishes the perception of pain as well as a subjective psychological illusion that diminishes the anxiety that motivates the procedure.

For all the above, the investigators will study as a main objective the differences between the use of virtual reality through the use of virtual reality glasses "Oculus go model", to reduce the perception of pain and anxiety motivated by the performance of a outpatient hysteroscopy versus clinical practice. It is usual not to use analgesia, using the VAS pain scale and the STAI (State-Trait Anxiety Inventory) questionnaire to assess the state of anxiety before and after the test. In addition, as secondary objectives, the investigators will compare different aspects such as surgical time used, determination of vital signs, satisfaction studies ...

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effect of Virtual Reality on the Reduction of Pain in Women with an Indication for Outpatient Diagnostic Hysteroscopy: A Randomized Controlled Trial.
   Pelazas-Hernández JA, Varillas-Delgado D, González-Casado T, Cristóbal-Quevedo I, et al · · 2023 · cited 16× · PMID 37297840 · DOI 10.3390/jcm12113645