Endometriosis and Psychological Support

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828591
• Other study ID #: ENDO.PS.
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 2019

Study information

• Verified date: May 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Alessandro Arena, MD
• Phone: 0512144385
• Email: alessandroarena1588[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• Intensive psychological support
Two meeting with a psychologist during the hospitalization (the first two days after surgery; the second one at the moment of the hospitalization discharge)
• Standard psychological support
Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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