Endometriosis and Psychological Support

NCT ID: NCT03828591

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A (intensive support)

Patients that receive standard and intensive psychological support during hospitalization

Group Type OTHER

Intensive psychological support

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery

Group B (standard support)

Patients that receive only standard psychological support during hospitalization

Group Type OTHER

Standard psychological support

Intervention Type PROCEDURE

Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery

Interventions

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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)

Intervention Type PROCEDURE

Standard psychological support

Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Renato Seracchioli

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Arena, MD

Role: CONTACT

0512144385

Facility Contacts

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Alessandro Arena, MD

Role: primary

0512144385

Other Identifiers

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ENDO.PS.

Identifier Type: -

Identifier Source: org_study_id

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