Endometriosis and Psychological Support

Study Overview
=================
Brief Summary
-----------------
Endometriosis is a common disease, causing significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically reducing patients' quality of life. Endometriosis surgery is often a stressful event for the patient. For that reason, psychological support can improve patients' general health state.

Detailed Description
-----------------
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study. Psychological support is offered to all women one month before and one month after surgery. A group of patients will receive intensive psychological support during hospitalization. Patients are divided into 2 groups: Group A: patients receiving intensive psychological support during hospitalization Group B: patients not receiving intensive psychological support during hospitalization After surgery, patients will be included in the post-operative follow-up, as usual in the investigator's clinical practice.

Official Title
-----------------
The Impact of Psychological Support During the Hospitalization in Women With Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Procedure: Intensive psychological support
* Procedure: Standard psychological support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery for endometriosis Patients that have signed an informed consent Exclusion Criteria: Patients with active or history of psychological/psychiatric diseases Patients that refuse psychological support

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A (intensive support)<br>Patients that receive standard and intensive psychological support during hospitalization | Procedure: Intensive psychological support<br>* Two meeting with a psychologist during the hospitalization (the first two days after surgery; the second one at the moment of the hospitalization discharge)<br>Procedure: Standard psychological support<br>* Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery<br>|
| Other: Group B (standard support)<br>Patients that receive only standard psychological support during hospitalization | Procedure: Standard psychological support<br>* Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health state | Measurement of quality of life of patients underwent surgery for endometriosis, using the validated questionnaire Clinical Outcomes In Routine Evaluation, with a total score from 1 (the best outcome) to more than 85 (the worse outcome), where: 1 to 20 is Healthy; 21 to 33 is Low level; 34 to 50 is Mild level; 51 to 67 is Moderate level; 68 to 84 is Moderate to severe level; more than 85 is Severe level. The questionnaire is submitted one month before surgery and at the hospitalization discharge. | From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain: Numeric Rating Scale | Evaluation of postoperative pain using Numeric Rating Scale, from 0 to 10 (where 0 is no pain and 10 is the worse pain ever). | Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery | 
| Anxiety and Depression | Measurement of anxiety and depression of patients underwent surgery for endometriosis, using the validated questionnaire Hospital Anxiety and Depression Scale, from 0 (the best outcome) to 21 (the worse outcome), where: 0 to 7 is Normal; 8 to 10 is Borderline case; 11 to 21 is Abnormal. | From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery | 
| Stress | Measurement of stress in patients underwent surgery for endometriosis, using the validated questionnaire Perceived Stress Scale, from 0 (the best outcome) to 40 (the worse outcome), where scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress. | From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Psychological support