Endometriosis
Conditions
Keywords
Endometriosis, Psychological support
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.
Interventions
PROCEDUREIntensive 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)
PROCEDUREStandard psychological support
Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General health state | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain: Numeric Rating Scale | Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery | 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 | From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery | 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 | From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery | 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. |
Countries
Italy
Contacts
Primary ContactAlessandro Arena, MD
Outcome results
None listed