Actively Recruiting
Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy: A Randomized Controlled Trial (RELIEF)
Led by Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI) · Updated on 2026-06-05
156
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether reading a personal narrative book can help improve emotional regulation and reduce negative feelings like catastrophizing, anxiety, and depression in women of childbearing age preparing for hysterectomy surgery. This trial compares this new approach with standard care, which includes an information leaflet and psychological consultation if needed. The study aims to find out if the narrative book enhances psychological well-being and patient satisfaction before and after surgery. Participants are randomly assigned to one of two groups: one receiving standard care alone, and the other receiving standard care plus the personal narrative book. The book is written by a patient who underwent hysterectomy, offering personal insights. Both groups may have access to psychological support if needed. The time between initial inclusion and surgery is between one to three months. During the study, women provide oral consent and complete questionnaires about their emotional and psychological state. Researchers measure adaptive emotional regulation, anxiety, depression, catastrophizing, use of supportive measures, and patient satisfaction both before and after surgery. The trial lasts from inclusion until surgery and up to three months afterward, focusing on psychological outcomes and overall patient experience.
CONDITIONS
Brief Title
Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy (RELIEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 months
Participants receive either standard care or supportive care including reading a personal narrative book and consultations to help with emotional regulation before surgery.
1 to 2 visits depending on supportive care needs
Duration - Day of surgery
Participants undergo hysterectomy surgery.
1 visit (in-person surgery)
Duration - 1 to 3 months
Participants are followed for emotional regulation, anxiety, depression, and use of additional supportive measures after surgery.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Clinique Tivoli-Ducos
Bordeaux, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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