Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicenter Italian Validation of EHP-30

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350413
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
University of Siena
University of Foggia
University of Padova
University of Pisa
Santa Chiara Hospital
Information provided by (Responsible Party):
Stefano Angioni, University of Cagliari

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.


Condition or disease Intervention/treatment
Endometriosis Quality of Life Other: The Endometriosis Health Profile EPH-30

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Multicenter Italian Validation of EHP-30 at Centres Located in the Territory
Actual Study Start Date : May 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Endometriosis
Women referred to five Obstetrics and Gynecological Department for the treatment of endometriosis
Other: The Endometriosis Health Profile EPH-30
Self-reported questionnaires
Other Names:
  • Sf 36
  • HADS
  • BAT
  • FSFI
  • Biberglou's scale
  • VAS Pain




Primary Outcome Measures :
  1. EHP- 30 The Endometriosis Health Profile [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks ]
    The EHP is the only condition-specific PRO designed from the patient's perspective to assess health related quality of life in endometriosis.The core questionnaire is composed of 30 items grouped into five scales: pain (11 items), control & powerlessness (6 items), emotional well-being (6 items), social support (4 items), and self-image (3 items). The modular questionnaire is composed of 23 items grouped into 6 scales: work life (5 items), relationship with children (2 items), sexual inter- course (5 items), medical profession (4 items), treatment (3 items), and infertility (4 items). The modular question- naire is characterized by the possibility of responding only to scales which the patient deems relevant to her. All scales can achieve a minimum score of 0, indicating low disabil- ity, and a maximum score of 100, indicating high disabil- ity. All items of a scale must be answered to be able to calculate a scale score.

  2. SF-36 BPS Short Form 36 Bodily Pain Scale [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks ]

    The SF-36 BPS assesses bodily pain intensity and interference of pain with normal activities The SF-36 BPS is a 2-item scale.Responses for each of the 2 SF-36 BPS items are recoded into final item values . The raw scale score is computed as a simple algebraic sum of the recoded item values. The raw scale score is then transformed to a 0-100 scale. Norm-based scores may be calculated for SF-36v2 by including population normative data in the scoring algorithms. The BPS score is only calculated if both items are completed.

    Score interpretation. SF-36v1 BPS scores range from 0-100. A higher score indicates lack of bodily pain. SF-36v2 uses norm-based scoring, where 50 is the "average" for the population. Therefore, scores above or below 50 can be considered above or below, respectively, the population average health status for bodily pain, and scores can be interpreted based on deviance from the mean (10 points = 1 SD). Population normative data are available for the US and UK


  3. HADS Hospital Anxiety and Depression Scale [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks ]
    It is commonly used by doctors to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.This, it was hoped, would create a tool for the detection of anxiety and depression in people with physical health problems.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Do Higher scores represent a worse outcome and is noted that the patient suffers from depression and anxiety

  4. BAT Body Attitude Test [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks ]
    is a self-report questionnaire composed of 20 items and is aimed at measuring the participant's attitude toward their body, while effectively detecting cases of negative body perception even when not associated with eating disorders. This ques- tionnaire is thought to measure three areas of body experience mainly: (a) negative apprecia- tion of body size (Fact 1); (b) lack of familiarity with one's own body (Fact 2); and (c) general body dissatisfaction (Fact 3). High scores (maxi- mum is 100) correspond to a higher degree of body dissatisfaction

  5. FSFI Female Sexual Function Index [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks ]
    self-reporting questionnaire made up of 19 items evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The full-scale score is a minimum of 2.0 and a maximum of 36.0 and is obtained by adding the scores of each of the domains. A low score is significant for decreased sexual function, but for the pain domain, low scores indicate greater pain.

  6. VAS PAIN Visual Analog Scale for Pain [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks ]
    The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients ( hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)

  7. Biberoglu and Behrman scale [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4 weeks ]
    The Biberoglu and Behrman scale consists of three patient-reported symptoms (dysmenorrhea, dyspareunia, and pelvic pain not related to menses) and two signs assessed during pelvic examination (pelvic tenderness and induration). Each of which are graded on a scale from 0 to 3 (or 4), with higher numbers indicating more severe symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women referred to five Obstetrics and Gynecological Department for the treatment of endometriosis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350413


Locations
Layout table for location information
Italy
University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, Italy, 09042
Sponsors and Collaborators
University of Cagliari
University of Siena
University of Foggia
University of Padova
University of Pisa
Santa Chiara Hospital
Investigators
Layout table for investigator information
Principal Investigator: Stefano Angioni, MD, PhD University of Cagliari
Additional Information:

Layout table for additonal information
Responsible Party: Stefano Angioni, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT02350413    
Other Study ID Numbers: ENDOCA1415
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis