The Impact of Psychological Support During the Hospitalization in Women With Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- General health state
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group A (intensive support)
Patients that receive standard and intensive psychological support during hospitalization
Intervention: Intensive psychological support (Procedure)
Group A (intensive support)
Patients that receive standard and intensive psychological support during hospitalization
Intervention: Standard psychological support (Procedure)
Group B (standard support)
Patients that receive only standard psychological support during hospitalization
Intervention: Standard psychological support (Procedure)
Outcomes
Primary Outcomes
General health state
Time Frame: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
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 Outcomes
- Postoperative pain: Numeric Rating Scale(Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery)
- Stress(From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery)
- Anxiety and Depression(From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery)
Investigators
Renato Seracchioli
principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna