Anxiety, Catastrophizing, Depression, Hysterectomy
Conditions
Brief summary
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: * Does the use of a personal narrative book improve adaptive emotional regulation and reduce catastrophizing, anxiety, and depressive symptoms in the preoperative period? * Does this intervention improve postoperative patient satisfaction and reduce the need for additional supportive measures? 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: * provide explicit oral informed consent; * complete questionnaires on their emotional and psychological experience; * read a personal narrative book if they are randomized to the intervention group.
Interventions
OTHERpersonal narrative book
Reading a personal narrative book written by a patient who underwent a hysterectomy
Sponsors
Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18 years or older and under 43 years of age * Patients with an indication for hysterectomy for a non-malignant condition * Patients who have provided explicit oral consent to participate * Patients covered by the French social security system * Patients able to read and understand French and capable of reading a French book within a timeframe compatible with the study schedule
Exclusion criteria
* Women with suspected uterine cancer or high-grade dysplasia * Women participating or having participated to an interventional clinical trial within the 30 days prior to inclusion * Pregnant, breastfeeding, or parturient women * Protected patient: adults under guardianship or other legal protection; persons deprived of liberty by judicial or administrative order; persons hospitalized without consent * Patients with insufficient proficiency in the French language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adaptive regulation | between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression | between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. | 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. |
| Adaptive and maladaptive regulation | between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. | 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. |
| Catastrophizing | between inclusion (D0) and surgery (S0), occurring 1 to 3 months later. | 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. |
| Use of additional supportive measures | at the inclusion (D0) | 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. |
| Patient satisfaction | Postoperative, occuring 1 to 3 months after inclusion. | The outcome is measured using the Likert-type satisfaction scale to determine satisfaction with their care. Responses range from "extremely satisfied" to "extremely dissatisfied." |
Countries
France
Outcome results
None listed