Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy (RELIEF) (RELIEF)

Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy: A Randomized Controlled Trial (RELIEF)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety; Hysterectomy; Catastrophizing
• Intervention / Treatment: Other: personal narrative book

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Clinique Tivoli-Ducos
    • Contact: Dr. Adrien Crestani; Phone Number: 07 85 30 63 45; Email: recherche@ifemendo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; CNGOF information leaflet with a consultation with a psychologist or other additional supportive measures if needed.
Experimental: Intervention ("Personal Narrative" arm); CNGOF information leaflet, personal narrative book, and a consultation with a psychologist or other additional supportive measures if needed.	Other: personal narrative book; Reading a personal narrative book written by a patient who underwent a hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI)

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: SCERI_2025_RIPH2_2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No