Ignite Creation Date:
2025-12-18 @ 8:14 AM
Ignite Modification Date:
2025-12-18 @ 8:14 AM
Study NCT ID:
NCT03827824
Status:
None
Last Update Posted:
2023-05-19 00:00:00
First Post:
2019-01-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality on Perception of Pain and Anxiety by Hysteroscopy
Sponsor:
None
Organization:
Study Overview
Official Title:
Intervention Study to Measure the Effect on Perception of Pain and Anxiety in Women With Indication for Diagnostic Hysteroscopy Through the Use of Virtual Reality
Status:
None
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Complete collection of study patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hysteroscopy
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: