Endometriosis and Psychological Support

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

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: Intensive psychological support; Procedure: Standard psychological support

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro Arena, MD; Phone Number: 0512144385; Email: alessandroarena1588@gmail.com

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi
      • Contact: Alessandro Arena, MD; Phone Number: 0512144385; Email: alessandroarena1588@gmail.com
      • Principal Investigator: Renato Seracchioli, MD
      • Principal Investigator: Alessandro Arena, MD
      • Principal Investigator: Federica Manzara, MD
      • Principal Investigator: Chiara Ferracuti, Psychologist
      • Sub-Investigator: Manuela Mastronardi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A (intensive support); Patients that receive standard and intensive psychological support during hospitalization	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); 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
Other: Group B (standard support); Patients that receive only standard psychological support during hospitalization	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

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Endometriosis; Psychological support
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: ENDO.PS.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No