Effect of Reading a Personal Narrative Book on Emotional Regulation in Women of Childbearing Age Undergoing Hysterectomy: A Randomized Controlled Trial (RELIEF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 6
- 主要终点
- Adaptive regulation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard care
CNGOF information leaflet with a consultation with a psychologist or other additional supportive measures if needed.
Intervention ("Personal Narrative" arm)
CNGOF information leaflet, personal narrative book, and a consultation with a psychologist or other additional supportive measures if needed.
干预措施: personal narrative book (Other)
结局指标
主要结局
Adaptive regulation
时间窗: 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.
次要结局
- 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.)
- Patient satisfaction(Postoperative, occuring 1 to 3 months after inclusion.)