Effect of Mediterranean Diet and Physical Activity in Patients With Endometriosis (PHAMEDENDO)
|ClinicalTrials.gov Identifier: NCT03994432|
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Behavioral: intervention group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Mediterranean Diet and Physical Activity in Patients With Symptomatic Endometriosis in Therapy With Estrogen-progestins or Progestins: a Randomized Controlled Trial|
|Actual Study Start Date :||January 10, 2019|
|Estimated Primary Completion Date :||July 20, 2020|
|Estimated Study Completion Date :||July 20, 2020|
Experimental: Intervention group
patients with symptomatic endometriosis in therapy with estro-progestins or progestins, who will be asked to follow a mediterranean diet and to practice an aerobic physical exercise according to the "7-minutes workout" model
Behavioral: intervention group
follow a mediterranean diet and practice a regular aerobic exercise according to the "7-minutes workout" model.
No Intervention: Control group
patients with symptomatic endometriosis in therapy with estro-progestins or progestins.
- Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]The presence and severity of dysmenorrhea, deep dyspareunia, and non-menstrual pelvic pain will be assessed using an 11-point numeric rating scale (NRS), with 0 indicating absence of pain and 10 pain as bad as it could be. Scores 1 to 4 will be considered mild pain, 5 to 7 moderate pain, and 8 to 10 severe pain. Patients will be considered for enrollment if they complained of at least moderate or severe pelvic pain (NRS score ≥ 4).
- The degree of satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]Patients will rate the degree of satisfaction with their treatment according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
- Changes in state of anxiety and depression in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]To determine states of anxiety and depression we'll use the Hospital Anxiety and Depression Scale (HADS) that is a self-assessment mood scale specifically designed for use in non-psychiatric hospital outpatients. It comprises 14 questions, 7 for the anxiety subscale and 7 for the depression subscale. Lower scores indicate better psychological status.
- Changes in sexual dysfunction and sexual satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]We'll use the Female Sexual Function Index (FSFI) questionnaire that is a 19-item, multidimensional, self-report instrument for evaluating the main categories of female sexual dysfunction and sexual satisfaction. Domains include desire, arousal, lubrication, orgasm, satisfaction and pain. Each domain is scored on a scale of 1 to 5, and the maximum transformed full-scale score is 36, with a minimum full-scale score of 2.0. Women with a FSFI total score below 26.55 are categorized as experiencing sexual dysfunction
- Changes in quality of life in patients with endometriosis who follow a mediterranean diet and a regular physical activity. [ Time Frame: 12 months ]Quality of life will be assessed with the Short-Form 12 (SF-12) health survey, developed from the original SF-36 questionnaire, a well-known, validated self-administered 12-item instrument. It measures health dimensions covering functional status, well-being, and overall health. Information from the 12 items is used to construct physical (PCS-12) and mental (MCS-12) component summary measures, with higher scores indicating better health perception.
- Changes in global improvement over time in patients with endometriosis who follow a mediterranean diet and a regular physical activity. [ Time Frame: 12 months ]Overall improvement will be assessed by participants using the Patient Global Impression of Change scale, a 7-point categorical scale recommended for use in chronic pain studies as a core outcome measure of global improvement over time.According to this single-item rating system, the response during treatment is indicated by choosing one among seven alternative options, i.e., "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994432
|Contact: Laura Buggio, MDfirstname.lastname@example.org|
|Contact: Elena Roncella, MDemail@example.com|
|Laura Buggio Centro Endometriosi e Metrorragie Clinica Mangiagalli, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico||Recruiting|
|Milan, Italy, 20122|
|Contact: Laura Buggio, MD, PhD +39 02 55032917 firstname.lastname@example.org|
|Contact: Elena Roncella, MD, PhD +39 02 55032917 email@example.com|