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NCT Number: NCT07430488

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

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Key information

Conditions

Hysterectomy Anxiety Anxiety Disorders Behavior Behavioral Symptoms Catastrophizing Depression Mental Disorders

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Tivoli-Ducos, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

personal narrative book

Other

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

Primary outcomes

  1. Adaptive regulation

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

    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.

Secondary outcomes

  1. Anxiety and depression

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

    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.

  2. Adaptive and maladaptive regulation

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

    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.

  3. Catastrophizing

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

    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.

  4. Use of additional supportive measures

    Time frame: at the inclusion (D0)

    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.

  5. Use of additional supportive measures

    Time frame: Postoperative, occuring 1 to 3 months after inclusion.

    The questionnaire is completed by the patient. The questions are independent and do not generate a score.

  6. Patient satisfaction

    Time frame: Postoperative, occuring 1 to 3 months after inclusion.

    The outcome is measured using the Likert-type satisfaction scale to determine satisfaction with their care. Responses range from "extremely satisfied" to "extremely dissatisfied."

Sponsors and collaborators

Lead sponsor

Groupe SantéCité SantéCité Enseignement-Recherche-Innovation (GCS SCERI)

Other

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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