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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Endocare will be administred through a virtual reality headseat used one to twice a day.
Digital control will be administred through a virtual reality headseat used one to twice a day.
Clinique Tivoli Ducos
Bordeaux, Gironde, France
RECRUITINGPain intensity change
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).
Time frame: 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)
Change in pain intensity
Change in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).
Time frame: at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5)
Change in pain relief
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)
Time frame: 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)
Weighted average change in pain intensity
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).
Time frame: 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)
Change in stress value
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'.
Time frame: at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)
Change in fatigue value
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)
Time frame: at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)
Change in endometriosis-related quality of life
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"
Time frame: At inclusion visit Day 0 and at through study completion (Day 6), an average of one week
Assessment of the predictive value of dramatization and catastrophizing thoughts
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).
Time frame: At the inclusion visit Day 0
Pain relief treatments
Number, frequency and dosage of pain relief treatments assessed by patient diary
Time frame: during the five days of treatment (Day 1 to Day 5) at bedtime
Assessment of satisfaction
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).
Time frame: through study completion (Day 6), an average of one week
Assessment of Clinical Global Impression of Improvement
Assessment of Clinical Global Impression of Improvement by CGI scale. It is a 7-point scale (1=very much improved; 7=very much worse)
Time frame: through study completion (Day 6), an average of one week
Incidence of adverse events and treatment adherence
Incidence of adverse events and treatment adherence collected by patients diary and phone
Time frame: during the five days of treatment (Day 1 to Day 5)
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