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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Adaptive regulation [Срок оценки: between inclusion (D0) and surgery (S0), occurring 1 to 3 months later.]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 4 центра

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

Идентификаторы

NCT: NCT07430488 · SCERI_2025_RIPH2_2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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