Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy

NCT ID: NCT03827824

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-30
• Study Completion Date: 2020-12-31

Brief 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 ...

Detailed Description

A Cochrane review (included 32 clinical trials and 3304 patients) concluded that there was no effective and safe treatment for pain relief in patients undergoing outpatient hysteroscopy. In the same way, The Gynecology and Obstetrics Spanish Society (SEGO) discourages the routine use of analgesics prior to the test or the use of local anesthesia or sedation, since neither improves the pain nor the satisfaction of the patients in this type of test.

Nowadays, is knowed 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.

With all this, the investigators intend to assess through this study if patients with medical indication for diagnostic hysteroscopy can benefit from the use of Virtual Reality for the decrease in their perception of pain, anxiety or increase in the degree of satisfaction with their performance.

1. - Design: Randomized intervention clinical trial

2. - Sample: by contrast of hypothesis, a sample size of 90 women with an established medical indication for outpatient hysteroscopy was determined. They were randomized using excel software. As criteria of inclusion, those of SEGO with ages between 18 and 75 years were used. Criteria of exclusion those of the test, presenting some type of illness or disability that contraindicate the use of Virtual Reality (blindness, deafness, epilepsy, etc), voluntary wish of no inclusion or inability to understand the study.

3. - Methodology:

• parameters to analyze:

• the average decrease in the perception of pain in both groups using the Visual Analogue Scale (VAS) with determinations at the end, at 15 and 30 minutes.
• the average decrease in the perception of the state of anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire prior to the performance of the test and after it.
• Modifications in the degree of satisfaction with the test by means of a STAI questionnaire included in the protocol of the Gynecology Service of El Escorial University Hospital.
• Changes in parameters such as blood pressure, heart rate and oxygen saturation before, during and after hysteroscopy.
• The influence of different circumstances such as age, parity, on the painful perception, state of anxiety or degree of satisfaction in both arms of the study.
• A 5 mm Bettocchi hysteroscope model will be used as a physiological serum distension medium and initial irrigation pressures of 75 mm Hg.
• Semi-rigid 5 Charr instruments (scissors, grasping forceps and biopsy).
• Oculus Go virtual reality glasses.
• The recruitment time will be that necessary to obtain the sample size.
• The patients will be given the STAI anxiety scale that will be completed prior to accessing the room. Once sitting on the examination table, a pulse oximeter will be placed on the left index finger, a cuff for measuring blood pressure on the right arm, and in the selected group virtual reality glasses, the first determination of blood pressure, heart rate and oxygen saturation is made at this time and will be repeated when accessing the endometrial cavity and immediately after removing the hysteroscope. After completing the test, still sitting and removed the virtual reality components will be given VAS for pain determination during the test. After dressing, the pain will be assessed using VAS at 15 and 30 minutes after the end of the test. Before leaving, a new STAI anxiety state will be delivered that will complete as well as respond to the two questions of the satisfaction protocol.

Conditions

Uterine Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hysteroscopy & Virtual reality glasses

Hysteroscopy with use of virtual reality glasses

Group Type: EXPERIMENTAL

Hysteroscopy & virtual reality glasses

Intervention Type: DEVICE

Hysteroscopy. Virtual reality glasses. VAS. STAI scale.

Hysteroscopy

Intervention Type: DEVICE

Hysteroscopy. VAS. STAI scale.

Hysteroscopy

Hysteroscopy without use of virtual reality glasses

Group Type: ACTIVE_COMPARATOR

Hysteroscopy

Intervention Type: DEVICE

Hysteroscopy. VAS. STAI scale.

Interventions

Hysteroscopy & virtual reality glasses

Hysteroscopy. Virtual reality glasses. VAS. STAI scale.

Intervention Type: DEVICE

Hysteroscopy

Hysteroscopy. VAS. STAI scale.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women with an established indication for diagnostic hysteroscopy according to the Spanish Society of Gynecology and Obstetrics (SEGO) criteria collected in its document of consensus, updated in 2013, with the title of "Hysteroscopy in consultation".
• Age between 18 and 75 years.
• Suitable cultural level for the understanding of the characteristics of the study.
• Signature of informed consent.

Exclusion Criteria

• Not be within the criteria established by SEGO for the realization of a hysteroscopy diagnostic.
• Existence of contraindication for hysteroscopy.
• Present some type of disease or disability that can intervene in the object of the study: visual deficit, auditory or sensory severe, illnesses or mental syndromes.
• Having suffered seizures, loss of knowledge, or other symptoms related to epileptic disorders that discourages the use of virtual reality glasses.
• Women who cannot tolerate the pain at the beginning and during hysteroscopy.
• Not signature of informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jesús Pelazas Hernández

UNKNOWN

Sponsor Role: collaborator

David Varillas Delgado

UNKNOWN

Sponsor Role: collaborator

Ignacio Cristóbal García

UNKNOWN

Sponsor Role: collaborator

Teresa González Casado

UNKNOWN

Sponsor Role: collaborator

Ignacio Cristóbal Quevedo

UNKNOWN

Sponsor Role: collaborator

Agustina Alonso Bermejo

UNKNOWN

Sponsor Role: collaborator

Marina Ronchas Martínez

UNKNOWN

Sponsor Role: collaborator

Universidad Francisco de Vitoria

OTHER

Sponsor Role: lead

Responsible Party

David Varillas Delgado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesús V Pelazas Hernández, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital El Escorial

Locations

David Varillas Delgado

Pozuelo de Alarcón, Madrid, Spain

Countries

Spain

Other Identifiers

12.18

Identifier Type: -

Identifier Source: org_study_id