跳至主要内容
临床试验/NCT07137377
NCT07137377招募中不适用

CESARCOM Study Protocol: Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections, - a Before-and-after Interventional Study

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
260
试验地点
1
主要终点
Post elective cesarean anxiety level

研究概览

简要总结

Background:

Anxiety is highly prevalent before elective caesarean sections and can have a negative impact on anesthetic outcomes, postoperative pain and maternal mental health. The use of pharmacological premedication is controversial, and non-pharmacological alternatives are increasingly being explored. Therapeutic communication, based on empathy, positive language and the conscious avoidance of negative or anxiety-inducing suggestions, has shown promise in other surgical settings. However, its effectiveness in obstetrics remains to be explored.

Methods This is a single-centre, prospective, observational, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training programme on therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study includes two groups of 130 patients each, one before the intervention and one after. Anxiety levels will be assessed using the French version of the State-Trait Anxiety Inventory score, and the primary outcome will be the difference in scores after caesarean section between the two groups. Secondary outcomes include the proportion of patients with high anxiety levels (STAI-State score >45), as well as staff satisfaction, feeling of relevance, and indicators of the feasibility of implementing the training.

The intervention consists of a short (less than 1 hour) training course using podcasts and flashcards, combined with distributing a lexicon that promotes hypnosis-based therapeutic communication (HBTC). Staff participation, perceived relevance and satisfaction will be assessed using structured questionnaires based on the Likert scale.

Linear and logistic regression analyses will be used to adjust for confounding variables, including baseline anxiety, psychiatric history, and intraoperative complications.

Discussion This is the first study to evaluate the impact of a dedicated HBTC training programme on patient anxiety and staff experience in an obstetric surgical setting. By integrating this approach into routine cesarean section care, our aim is to improve the patient experience and enhance communication practices within clinical teams. The results could inform clinical practices on non-pharmacological strategies in obstetric care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Patients' do not know if they are in the pre intervention group or in the post intervention group. The statistician will not know which is the pre or the post intervention group either.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •elective c-section planned in the Maternity Unit of the Geneva University Hospitals
  • •consent to participate

排除标准

  • •Not-French-speaking patients (interpreter required).
  • •All emergency c-sections.
  • •Death during the intervention.

研究组 & 干预措施

Pre intervention group (before hypnosis-based therapeutic communication reaching programme)

No Intervention

Patients' anxiety levels before the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics.

post intervention group (after hypnosis-based therapeutic communication teaching programme)

Experimental

Patients' anxiety levels after the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics.

干预措施: On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards) (Behavioral)

结局指标

主要结局

Post elective cesarean anxiety level

时间窗: Within 24 hours after cesarean.

To assess the impact of a therapeutic communication wordbook and hypnosis-based therapeutic communication teaching programme on patients' anxiety levels after elective c-section and the proportion of elevated anxiety levels after elective c-sections, before and after implementation of a therapeutic communication protocol/short teaching programme. Patients' will receive State-State Anxiety Inventory (STAI) scores by email and complete them on line. Their result will be directly transfer to REDCap, data management software. We will report difference of means of the post c-section anxiety assessed with the STAI score (as a continuous variable), each patient result being adjusted on its pre c-section STAI score (result at baseline). Minimum STAI score result=20; maximum=80. The higher the score, the greater the level of anxiety.

次要结局

  • High anxiety levels proportion(Within the 24 hours after cesareans.)
  • Providers satisfaction(At 6 and 12 months after the programme)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Océane Pécheux

Principal investigator

University Hospital, Geneva

研究点 (1)

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