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Endometriosis and Psychological Support

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Unknown

Conditions

Endometriosis

Treatments

Procedure: Intensive psychological support
Procedure: Standard psychological support

Study type

Interventional

Funder types

Other

Identifiers

NCT03828591
ENDO.PS.

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Group A (intensive support)
Other group
Description:
Patients that receive standard and intensive psychological support during hospitalization
Treatment:
Procedure: Standard psychological support
Procedure: Intensive psychological support
Group B (standard support)
Other group
Description:
Patients that receive only standard psychological support during hospitalization
Treatment:
Procedure: Standard psychological support

Trial contacts and locations

1

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Central trial contact

Alessandro Arena, MD

Data sourced from clinicaltrials.gov

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