NCT03828591

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

January 24, 2019

Last Update Submit

May 13, 2019

Conditions

Endometriosis

Keywords

EndometriosisPsychological support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Postoperative pain: Numeric Rating Scale

    Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery

  • Anxiety and Depression

    From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery

  • Stress

    From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery

Study Arms (2)

Group A (intensive support)

OTHER

Patients that receive standard and intensive psychological support during hospitalization

Procedure: Intensive psychological supportProcedure: Standard psychological support

Group B (standard support)

OTHER

Patients that receive only standard psychological support during hospitalization

Procedure: Standard psychological support

Interventions

Intensive psychological supportPROCEDURE

Two meeting with a psychologist during the hospitalization (the first two days after surgery; the second one at the moment of the hospitalization discharge)

Group A (intensive support)
Standard psychological supportPROCEDURE

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

Group A (intensive support)Group B (standard support)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing surgery for endometriosis
  • Patients that have signed an informed consent

You may not qualify if:

  • Patients with active or history of psychological/psychiatric diseases
  • Patients that refuse psychological support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Alessandro Arena, MD

CONTACT

0512144385alessandroarena1588@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 24, 2019

First Posted

February 4, 2019

Study Start

March 1, 2019

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

IT(1)