Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03827824 |
| Other study ID # |
12.18 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 30, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
July 2022 |
| Source |
Universidad Francisco de Vitoria |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 ...
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.
