Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age … (NCT07430488) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy (RELIEF)
France156 participantsStarted 2026-05-13
Plain-language 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.
Who can participate
Age range
18 Years – 42 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adaptive regulation
Timeframe: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.