NCT07430488 Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy (RELIEF)
| NCT ID | NCT07430488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI) |
| Condition | Hysterectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 156 participants in total. It began in 2026-05-13 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07430488 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying Hysterectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07430488 currently recruiting?
Yes, NCT07430488 is actively recruiting participants. Visit ClinicalTrials.gov or contact Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI) to inquire about joining.
Where is the NCT07430488 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT07430488 clinical trial?
NCT07430488 is sponsored by Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI). The trial plans to enroll 156 participants.