Endometriosis and Psychological Support
Primary Purpose
Endometriosis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intensive psychological support
Standard psychological support
Sponsored by
About this trial
This is an interventional other trial for Endometriosis focused on measuring Endometriosis, Psychological support
Eligibility Criteria
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
Sites / Locations
- Azienda Ospedaliero-Universitaria Sant'Orsola MalpighiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A (intensive support)
Group B (standard support)
Arm Description
Patients that receive standard and intensive psychological support during hospitalization
Patients that receive only standard psychological support during hospitalization
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
Full Information
NCT ID
NCT03828591
First Posted
January 24, 2019
Last Updated
May 13, 2019
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03828591
Brief Title
Endometriosis and Psychological Support
Official Title
The Impact of Psychological Support During the Hospitalization in Women With Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Psychological support
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (intensive support)
Arm Type
Other
Arm Description
Patients that receive standard and intensive psychological support during hospitalization
Arm Title
Group B (standard support)
Arm Type
Other
Arm Description
Patients that receive only standard psychological support during hospitalization
Intervention Type
Procedure
Intervention Name(s)
Intensive psychological support
Intervention Description
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
Intervention Name(s)
Standard psychological support
Intervention Description
Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery
Primary Outcome Measure Information:
Title
General health state
Description
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.
Time Frame
From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain: Numeric Rating Scale
Description
Evaluation of postoperative pain using Numeric Rating Scale, from 0 to 10 (where 0 is no pain and 10 is the worse pain ever).
Time Frame
Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery
Title
Anxiety and Depression
Description
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.
Time Frame
From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
Title
Stress
Description
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.
Time Frame
From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Arena, MD
Phone
0512144385
Email
alessandroarena1588@gmail.com
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Arena, MD
Phone
0512144385
Email
alessandroarena1588@gmail.com
First Name & Middle Initial & Last Name & Degree
Renato Seracchioli, MD
First Name & Middle Initial & Last Name & Degree
Alessandro Arena, MD
First Name & Middle Initial & Last Name & Degree
Federica Manzara, MD
First Name & Middle Initial & Last Name & Degree
Chiara Ferracuti, Psychologist
First Name & Middle Initial & Last Name & Degree
Manuela Mastronardi, MD
12. IPD Sharing Statement
Learn more about this trial
Endometriosis and Psychological Support
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