Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655584
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
ENDOREV A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ENDOREV A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDOREV
Brief Summary:
The aim of the research is to evaluate the effectiveness of virtual reality on the anxiety of patients with suspected endometriosis in gynecological consultation
Indeed several studies prove that patients in this situation are anxious We would like to offer help in reducing anxiety in this case by means of digital therapy
As part of this study the equipment used will be Bliss DTX This is a non-drug digital therapy digital therapeutics already used in various hospital departments
Bliss DTX immerses patients in sound and image programs scientifically developed for their effect on pain and anxiety mobilizing their abilities and placing them in an altered state of consciousness Bliss DTX software is delivered to patients via a dedicated video headset virtual reality and audio headset as part of an integrated solution
Conduct of the study
The patient will be taken care of on the day of the consultation by a clinical research nurse It will be installed in a reception room in the consultation room The nurse will give him a questionnaire on anxiety to complete before the consultation
A draw will be carried out with two options
1 Bliss DTX digital therapy via audio and video headphones lasting 13 minutes
2 Installation in the reception room while waiting for the doctor to arrive After the consultation the patient will complete a new questionnaire on her state of anxiety and her feelings during the consultation
A telephone call will be made 6 months after the consultation to collect post-consultation information
Duration
Duration of 6 months on 46 patients followed for 18 months Expected benefits
Reduction of anxiety after consultation by diversion of attention
Strengthening the bond of trust between the patient and the care team
Better monitoring and better compliance with treatment and medical examinations
Better pain management
Improved quality of life
Possible side effects
No particular risks or constraints however a virtual reality headset can cause symptoms such as nausea dizziness sweating paleness balance disorders grouped under the term cybernetosis as well as epileptic seizures in people subjects predisposed to convulsions
Indeed several studies prove that patients in this situation are anxious We would like to offer help in reducing anxiety in this case by means of digital therapy
As part of this study the equipment used will be Bliss DTX This is a non-drug digital therapy digital therapeutics already used in various hospital departments
Bliss DTX immerses patients in sound and image programs scientifically developed for their effect on pain and anxiety mobilizing their abilities and placing them in an altered state of consciousness Bliss DTX software is delivered to patients via a dedicated video headset virtual reality and audio headset as part of an integrated solution
Conduct of the study
The patient will be taken care of on the day of the consultation by a clinical research nurse It will be installed in a reception room in the consultation room The nurse will give him a questionnaire on anxiety to complete before the consultation
A draw will be carried out with two options
1 Bliss DTX digital therapy via audio and video headphones lasting 13 minutes
2 Installation in the reception room while waiting for the doctor to arrive After the consultation the patient will complete a new questionnaire on her state of anxiety and her feelings during the consultation
A telephone call will be made 6 months after the consultation to collect post-consultation information
Duration
Duration of 6 months on 46 patients followed for 18 months Expected benefits
Reduction of anxiety after consultation by diversion of attention
Strengthening the bond of trust between the patient and the care team
Better monitoring and better compliance with treatment and medical examinations
Better pain management
Improved quality of life
Possible side effects
No particular risks or constraints however a virtual reality headset can cause symptoms such as nausea dizziness sweating paleness balance disorders grouped under the term cybernetosis as well as epileptic seizures in people subjects predisposed to convulsions
Detailed Description:
Title
ENDOREV A solution to reduce anxiety during gynecological consultations in patients with suspected endometriosis
Description of the study
Single-center randomized controlled open-label interventional study on two parallel groups Study composed of 46 patients randomized into two groups A and B with a ratio of 11 Experimental Group A The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes Group B control The patient will be seated and wait for the doctor to arrive no material The duration of inclusion is 18 months and individual participation is 6 months that is to say 24 months for the entire study
Completion of the questionnaire IASTA Y-1 for both groups before the consultation and data collection
Filling of the CRF in consultation by the doctor Completion of the questionnaire IASTA Y-1 for both arms after the consultation and data collection Telephone call at 6 months with data collection on compliance with endometriosis monitoring
Objectives
Primary objectives
Evaluate the effectiveness of virtual reality on anxiety in women with suspected endometriosis during the gynecological consultation
Secondary objectives
Study the effect of virtual reality on compliance with endometriosis monitoring following the gynecological consultation
Evaluate the effect of virtual reality on the pain felt during the gynecological examination
Evaluate the level of satisfaction with the device during the session
Hypothesis
Null hypothesis H0 No significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores
Alternative hypothesis H1 There is a significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores
Inclusion criteria
Patient between 18 and 45 years old
Patient referred for suspected endometriosis
Patient consulting for the first time in the hospital
Patient with first-line or second-line imaging documenting endometriosis ultrasound or MRI
Patient agreeing to participate in the study and having signed informed consent
Patient affiliated to a social security scheme
Patient able to read and write French
Exclusion criteria
Patient with a history of major pelvic surgery for endometriosis
Patient undergoing hysterectomy
Virgin patient
Pregnant woman
Patient with psychiatric pathology
Patient suffering from proven epilepsy
Patient under judicial protection
Patient under guardianship or curatorship
Patient with visual or hearing impairment
Patient with a progressive pathology responsible for chronic pain
Place of the study
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
Contact details
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye Address 10 rue du Champ Gaillard 78300 Poissy Tel 33139274581 Email eliselunellight-yvelinesnordfr
Speakers
Promoter Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
Coordinating investigator Ms Elise LUNELLI registered nurse
Funding
GIRCI IDF and ARS IDF funding as part of the call for projects Appel à projets recherche en soins APRESO 2024
Calendar
Primary submission 110924 Secondary submission 260924
ENDOREV A solution to reduce anxiety during gynecological consultations in patients with suspected endometriosis
Description of the study
Single-center randomized controlled open-label interventional study on two parallel groups Study composed of 46 patients randomized into two groups A and B with a ratio of 11 Experimental Group A The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes Group B control The patient will be seated and wait for the doctor to arrive no material The duration of inclusion is 18 months and individual participation is 6 months that is to say 24 months for the entire study
Completion of the questionnaire IASTA Y-1 for both groups before the consultation and data collection
Filling of the CRF in consultation by the doctor Completion of the questionnaire IASTA Y-1 for both arms after the consultation and data collection Telephone call at 6 months with data collection on compliance with endometriosis monitoring
Objectives
Primary objectives
Evaluate the effectiveness of virtual reality on anxiety in women with suspected endometriosis during the gynecological consultation
Secondary objectives
Study the effect of virtual reality on compliance with endometriosis monitoring following the gynecological consultation
Evaluate the effect of virtual reality on the pain felt during the gynecological examination
Evaluate the level of satisfaction with the device during the session
Hypothesis
Null hypothesis H0 No significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores
Alternative hypothesis H1 There is a significant difference between groups on post-consultation anxiety scores after adjustment for pre-consultation anxiety scores
Inclusion criteria
Patient between 18 and 45 years old
Patient referred for suspected endometriosis
Patient consulting for the first time in the hospital
Patient with first-line or second-line imaging documenting endometriosis ultrasound or MRI
Patient agreeing to participate in the study and having signed informed consent
Patient affiliated to a social security scheme
Patient able to read and write French
Exclusion criteria
Patient with a history of major pelvic surgery for endometriosis
Patient undergoing hysterectomy
Virgin patient
Pregnant woman
Patient with psychiatric pathology
Patient suffering from proven epilepsy
Patient under judicial protection
Patient under guardianship or curatorship
Patient with visual or hearing impairment
Patient with a progressive pathology responsible for chronic pain
Place of the study
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
Contact details
Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye Address 10 rue du Champ Gaillard 78300 Poissy Tel 33139274581 Email eliselunellight-yvelinesnordfr
Speakers
Promoter Intercommunal Hospital Center of Poissy Saint-Germain-En-Laye
Coordinating investigator Ms Elise LUNELLI registered nurse
Funding
GIRCI IDF and ARS IDF funding as part of the call for projects Appel à projets recherche en soins APRESO 2024
Calendar
Primary submission 110924 Secondary submission 260924
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?:
None