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

NCT07430488 | Not Yet Recruiting

• 1 other identifier: SCERI_2025_RIPH2_2025-01
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hysterectomy; Anxiety; Depression; Catastrophizing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anxiety and depression

  between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.

• Adaptive and maladaptive regulation

  between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.

• Catastrophizing

  between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.

• Use of additional supportive measures

  at the inclusion (D0)

• Use of additional supportive measures

  Postoperative, occuring 1 to 3 months after inclusion.

Study Arms (2)

Standard care

NO INTERVENTION

CNGOF information leaflet with a consultation with a psychologist or other additional supportive measures if needed.

Intervention ("Personal Narrative" arm)

EXPERIMENTAL

CNGOF information leaflet, personal narrative book, and a consultation with a psychologist or other additional supportive measures if needed.

Other: personal narrative book

Interventions

personal narrative book OTHER

Reading a personal narrative book written by a patient who underwent a hysterectomy

Intervention ("Personal Narrative" arm)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• Women with suspected uterine cancer or high-grade dysplasia
• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02