Clinical trial NCT02350413: Multicenter Italian Validation of EHP-30
Official title: Multicenter Italian Validation of EHP-30 at Centres Located in the Territory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Quality of Life
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: University of Siena
name: University of Foggia
name: University of Padova
name: University of Pisa
name: Santa Chiara Hospital
First posted: 2015-01-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred to five Obstetrics and Gynecological Department for the treatment of endometriosis.

Brief summary: The experience of the chronic illness negatively engraves on the quality of life of patients. Endometriosis is a disease that affects millions of women of childbearing age; it has repercussions on psychological health, as shown by numerous recent studies.

The aim of the present study is to validate the italian version of EPH 30, a self reported questionnaire, already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.


Eligibility criteria: Inclusion Criteria:

* Previous surgical and histological diagnosis of endometriosis

Exclusion Criteria:

* Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
* Psychiatric diseases
* Refusal or inability to sign the informed consent

Primary outcomes:
measure: EHP- 30 The Endometriosis Health Profile
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks
measure: SF-36 BPS Short Form 36 Bodily Pain Scale
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks
measure: HADS Hospital Anxiety and Depression Scale
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks
measure: BAT Body Attitude Test
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks
measure: FSFI Female Sexual Function Index
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks
measure: VAS PAIN Visual Analog Scale for Pain
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks
measure: Biberoglu and Behrman scale
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: University of Cagliari,Obstetrics and Gynecological Department,
state: Cagliari
Study officials:
affiliation: University of Cagliari
name: Stefano Angioni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: