Endometriosis and Psychological Support

Not Applicable

• Conditions: Endometriosis
• Interventions: Procedure: Intensive psychological support; Procedure: Standard psychological support

• Registration Number: NCT03828591
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-03-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15
• Primary Completion: 2019-08
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (intensive support)	Standard psychological support	Patients that receive standard and intensive psychological support during hospitalization
Group B (standard support)	Standard psychological support	Patients that receive only standard psychological support during hospitalization
Group A (intensive support)	Intensive psychological support	Patients that receive standard and intensive psychological support during hospitalization

Primary Outcome Measures

Name	Time	Method
General health state	From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain: Numeric Rating Scale	Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery	Evaluation of postoperative pain using Numeric Rating Scale, from 0 to 10 (where 0 is no pain and 10 is the worse pain ever).
Stress	From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery	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.
Anxiety and Depression	From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery	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.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi; 🇮🇹 Bologna, BO, Italy