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Recruiting NCT07430488

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

No phase Interventional Hysterectomy Anxiety Depression Catastrophizing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: personal narrative book.
Who it may be relevant to
Registry conditions: Hysterectomy, Anxiety, Depression, Catastrophizing. Basic parameters: 18 years — 42 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Adaptive regulation [Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.]
Secondary outcome measures (6)
  • Anxiety and depression [Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.]
  • Adaptive and maladaptive regulation [Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.]
  • Catastrophizing [Time frame: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.]
  • Use of additional supportive measures [Time frame: at the inclusion (D0)]
  • Use of additional supportive measures [Time frame: Postoperative, occuring 1 to 3 months after inclusion.]
  • Patient satisfaction [Time frame: Postoperative, occuring 1 to 3 months after inclusion.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 4 centers
  • Clinique Tivoli-Ducos — Bordeaux
  • Clinique Charcot — Sainte-Foy-lès-Lyon
  • Clinique Pasteur Toulouse — Toulouse
  • Clinique St Cyprien Rive Gauche — Toulouse

Identifiers

NCT: NCT07430488 · SCERI_2025_RIPH2_2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗