Endocare® (Single Care) in Pain-related Endometriosis

Lucine45 enrolled

Overview

Endocare® treatment is a stand-alone software medical device, which is composed of a mobile application and an accessory VR headset, intended to mitigate the pain for patients prone to endometriosis. Mitigation of pain is realized through sequences of treatments via audio and visual stimulations. The Endocare® treatment's main functionality, which addressed the intended purpose, is conducting sequences for treatment to mitigate the pain sensed by the patient. The software will allow mitigating the sensed pain through 3D Virtual Reality via sequences of environments. The software will emit through sequences of 3D environments, auditory and visual stimulations. The medical device is a CE marked Class I device. Women suffering from endometriosis present recurrent pelvic pain impairing their quality of life. The endometriosis-related pain has pejorative repercussions on sexual, family and professional life. Currently, the physician armamentarium is limited to analgesics and non-steroid anti-inflammatory drugs to treat endometriosis-related pain. Endocare® treatment intends to relieve pain thanks to its action on central nervous system. This study will describe the evolution of pain in patients experiencing endometriosis-related pain after a single treatment of Endocare® or a digital control. The use of a digital control as a comparator is the only way to show a specific effect of the Endocare® treatment. Therefore, a digital control displaying visual and auditive sequences with no expected effect will be used for the study. This digital control, for which only a placebo effect may occur, will be displayed on a tablet instead of VR (Colloca et al., 2020). The main analysis will be performed on an intent-to-treat basis. The statistical analysis will be performed using the SAS 9.4 (or higher) software (SAS Institute, Cary, NC, USA). Continuous variables will be described by the number of observations, mean, standard deviation, minimum, maximum and median. Categorical variables will be described by the number and percentage of each modality. Percentages will be calculated on the number of observed data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometriosis Pain

Interventions

Virtual realityDEVICE

20 minutes treatment in virtual reality

Digital controlDEVICE

20 minutes digital control movie on tablet without virtual reality

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Woman ≥ 18 years old * With a diagnosis of endometriosis * Willing to participate in the study and having signed the informed consent form * Suffering from a moderate-to-severe endometriosis-related pain ≥ 4 on numerical rating scale (NRS) at the time of inclusion Exclusion Criteria: * Pregnant or breastfeeding woman * Woman having consumed painkillers within 8h prior inclusion * Woman participating in an interventional study or having participated in an interventional study within the 30 days before enrolment * Contraindication to Endocare® or digital control: patients with severe visual, hearing and/or cognitive impairments, patients with colour blindness, patients who are photo-sensitive or suffering from epilepsy or motion sickness * Woman being an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

Locations (1)

Clinique Tivoli Ducos

Bordeaux, Gironde, France

Outcomes

Primary Outcomes

Mean pain intensity 60 minutes after the beginning of treatment

Pain assessment evaluated with numerical rating scale (NRS): Pain assessed by 11-point numerical rating scale (NRS): 0=no pain; 10=unbearable pain

Time frame: 60 minutes after treatment

Secondary Outcomes

Evaluate the pain evolution after Endocare® compared to the digital control

Pain assessment evaluated with numerical rating scale (NRS): 11-point numerical scale (0=no pain; 10=unbearable pain)

Time frame: baseline (before treatment), 15 minutes, 30 minutes, 45 minutes, and 240 minutes after treatment

Evaluate the pain relief after Endocare ® compared to the digital control

The time to reach and maintain pain relief as assessed by the pain relief score ≥ 3 PRS is a 5-point categorical scale (0: no relief, 1: slight relief, 2: moderate relief, 3: lots of relief and 4: complete relief) The event will be defined by the first occurrence of PRS ≥ 3

Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment

Evaluate the maximum reduction in pain after Endocare® compared to the digital control

The time to reach and maintain pain reduction ≥30% and ≥50% evaluated with NRS 11-point numerical scale (0=no pain; 10=unbearable pain)

Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment

Describe the women satisfaction toward Endocare® or the digital control

Satisfaction after using Endocare® compared to the digital control, will be self-rated by the patient on a 7-point Likert scale: 1: extremely dissatisfied, 2: very dissatisfied, 3: rather dissatisfied, 4: neutral, 5: rather satisfied, 6: very satisfied, 7: extremely satisfied

Time frame: 240 minutes after treatment

Data from ClinicalTrials.gov

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