Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy

Summary

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 ...

Conditions

• Uterine Diseases

Interventions

DEVICE

Hysteroscopy & virtual reality glasses

Hysteroscopy. Virtual reality glasses. VAS. STAI scale.

DEVICE

Hysteroscopy

Hysteroscopy. VAS. STAI scale.

Sponsors & Collaborators

• Jesús Pelazas Hernández

  collaborator UNKNOWN

• David Varillas Delgado

  collaborator UNKNOWN

• Ignacio Cristóbal García

  collaborator UNKNOWN

• Teresa González Casado

  collaborator UNKNOWN

• Ignacio Cristóbal Quevedo

  collaborator UNKNOWN

• Agustina Alonso Bermejo

  collaborator UNKNOWN

• Marina Ronchas Martínez

  collaborator UNKNOWN

• Universidad Francisco de Vitoria

  lead OTHER

Principal Investigators

• Jesús V Pelazas Hernández, MD · Hospital El Escorial

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-30

Primary Completion

2019-10-30

Completion

2020-12-31

Countries

• Spain

Study Locations