Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home
Study Details
Study Description
Brief Summary
Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life.
Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.
Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.
Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.
The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endocare
|
Device: Endocare
Endocare will be administred through a virtual reality headseat used one to twice a day.
|
| Active Comparator: Digital control
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Device: Digital control
Digital control will be administred through a virtual reality headseat used one to twice a day.
|
Outcome Measures
Primary Outcome Measures
- Pain intensity change [Time points are before treatment (Time 0) and one hour after treatment (Time 1) during t five days (Day 1, Day 2, Day 3, Day 4, Day 5)]
The mean change in pain intensity assessed by a numeric rating scale (pain intensity numerical scale) between the pre-treatment measurement and one hour after the use of Endocare treatment, compared to the digital control during the five days of treatment.The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).
Secondary Outcome Measures
- Change in pain intensity [at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5)]
Change in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).
- Change in pain relief [At 1 hour (Time 1), 2 hours (Time 2) and 3 hours (Time 3) after treatment during the 5 days of treatment (Day 1 to Day 5)]
Change in pain relief assessed by Likert pain relief scale. Its a 5-point categorical scale (0: no relief, 1: slight relief, 2: moderate relief, 3: lots of relief and 4: complete relief)
- Weighted average change in pain intensity [from pre-treatment (Time 0) to 2 hours (Time 2) and 3 hours (Time 3) post-treatment during the 5 days of treatment (Day 1 to Day 5)]
Weighted average change (based on number of treatments Endocare or control uses) in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).
- Change in stress value [at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)]
Change in stress assessed by Visual Analogue Scale (VAS). Visual Analogue Scale (VAS) consists of a small unmarked 100 mm ruler with ends labelled 'none' and 'as bad as possible'.
- Change in fatigue value [at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)]
Change in stress assessed by Visual Analogue Scale (VAS) and fatigue assessed by Pichot Scale. The Pichot scale evaluates 8 fatigue items ranging from 0 to 4 (0: not at all; 1: a little; 2: moderately; 3: a lot; 4: extremely)
- Change in endometriosis-related quality of life [At inclusion visit Day 0 and at through study completion (Day 6), an average of one week]
Change in endometriosis-related quality of life assessed by Endometriosis Health Profile (EHP-5). The EHP-5 consists of 11 items ranging from "never" to "always"
- Assessment of the predictive value of dramatization and catastrophizing thoughts [At the inclusion visit Day 0]
Assessment of the predictive value of dramatization and catastrophizing thoughts assessed by Patient catastrophizing scale (PCS) coonsisting of 13 items ranging from 0 to 4 (0= not at all; 1= to a slight degree; 2= to a moderate degree; 3= to a great degree; 4 = all the time).
- Pain relief treatments [during the five days of treatment (Day 1 to Day 5) at bedtime]
Number, frequency and dosage of pain relief treatments assessed by patient diary
- Assessment of satisfaction [through study completion (Day 6), an average of one week]
Assessment of satisfaction by Likert scale. It is a 7-point Likert scale (1: extremely dissatisfied, 2: very dissatisfied, 3: dissatisfied, 4: neutral, 5: satisfied, 6: very satisfied, 7: extremely satisfied).
- Assessment of Clinical Global Impression of Improvement [through study completion (Day 6), an average of one week]
Assessment of Clinical Global Impression of Improvement by CGI scale. It is a 7-point scale (1=very much improved; 7=very much worse)
- Incidence of adverse events and treatment adherence [during the five days of treatment (Day 1 to Day 5)]
Incidence of adverse events and treatment adherence collected by patients diary and phone
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women over 18 years of age with diagnosed endometriosis (histology, imaging, clinical symptomatology) and/or adenomyosis.
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Women with at least 2 consecutive days per month of endometriosis-related pelvic-perineal pain of moderate to severe intensity (NS ≥ 4):
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Women without amenorrhea: pain around the onset of menstruation.
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Women with amenorrhea: most intense pain of the month.
Exclusion Criteria:
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Pregnant or nursing women.
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Women participating, or who have participated, in a clinical interventional study within 30 days prior to inclusion.
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Women with severe visual, auditory or cognitive impairment, color blindness, photosensitivity, epilepsy or motion sickness.
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Women whose pain is occasional and not present at each menstrual period.
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Women who have previously received virtual reality treatments.
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Women under judicial protection, guardianship, curatorship, protective mandate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Tivoli Ducos | Bordeaux | Gironde | France | 33000 |
Sponsors and Collaborators
- Lucine
- Biotrial
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-A02358-33