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The goal of this interventional clinical trial involving minimal risks and constraints is to evaluate whether an innovative approach to managing catastrophizing in the preoperative context of hysterectomy improves psychological outcomes compared to usual care in women of childbearing age who have been informed of an indication for hysterectomy.
The main questions it aims to answer are:
Researchers will compare standard care (CNGOF information leaflet with psychological consultation if needed) with an intervention including a personal narrative book in addition to standard care, to see if the intervention improves emotional regulation, psychological well-being, and satisfaction.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | CNGOF information leaflet with a consultation with a psychologist or other additional supportive measures if needed. | |
| Intervention ("Personal Narrative" arm) | Experimental | CNGOF information leaflet, personal narrative book, and a consultation with a psychologist or other additional supportive measures if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| personal narrative book | Other | Reading a personal narrative book written by a patient who underwent a hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adaptive regulation | The adaptative regulation is measured using the Cognitive Emotion Regulation Questionnaire - Adaptive (CERQ-A) wich include five adaptive subscales . Scores range from 20 to 100, with higher scores indicating better adaptive regulation. | between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and depression | The outcome is measured using the Hospital Anxiety and Depression Scale (HADS). The scale includes two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating more severe symptoms. | between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Tivoli-Ducos | Recruiting | Bordeaux | France |
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| Adaptive and maladaptive regulation |
This outcomes is measured using the Cognitive Emotion Regulation Questionnaire (CERQ). Two composite scores are derived: adaptive regulation and maladaptive regulation. The adaptative regulation is measured using the Cognitive Emotion Regulation Questionnaire - Adaptive (CERQ-A) wich include five adaptive subscales . Scores range from 20 to 100, with higher scores indicating better adaptive regulation. The maldaptative regulation is measured using the Cognitive Emotion Regulation Questionnaire - Non-Adaptive (CERQ-NA) wich include four maladaptive subscales. Scores range from 16 to 80, with higher scores indicating greater use of maladaptive regulation strategies. |
| between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. |
| Catastrophizing | The outcome is measured using the Symptom Catastrophizing Scale (SCS), a 7-item questionnaire assessing catastrophic thinking related to symptoms. Total scores range from 0 to 14. | between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. |
| Use of additional supportive measures | The questionnaire is completed by the physician based on the prescription made or recommended to the patient. The questions are independent and do not generate a score. | at the inclusion (D0) |
| Use of additional supportive measures | The questionnaire is completed by the patient. The questions are independent and do not generate a score. | Postoperative, occuring 1 to 3 months after inclusion. |
| Patient satisfaction | The outcome is measured using the Likert-type satisfaction scale to determine satisfaction with their care. Responses range from "extremely satisfied" to "extremely dissatisfied." | Postoperative, occuring 1 to 3 months after inclusion. |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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