Personal Cellphone Use During Elective Cesarean Section Under Regional Anesthesia and Its Psychological Impact on Maternal Anxiety, Stress and Satisfaction Levels: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Maternal Anxiety Levels During Elective Cesarean Section
研究概览
简要总结
This study looks at whether allowing mothers to use their personal cellphone during a planned cesarean section (C-section) under spinal anesthesia can reduce stress and anxiety and improve their overall birth experience. During a cesarean section under spinal anesthesia, the mother is awake, which can sometimes cause feelings of anxiety or stress.
Women taking part in this study will be randomly assigned to one of two groups. One group will be allowed to use their cellphone freely during the surgery, while the other group will follow the usual hospital practice, which does not allow cellphone use in the operating room. All medical care, anesthesia, and surgical procedures will be exactly the same for both groups.
The study will measure mothers' anxiety levels before surgery, during the operation, and within 24 hours after delivery using simple questionnaires. Mothers will also be asked about their satisfaction with their birth experience. In addition, the study will assess stress levels of a close family member (such as a partner) shortly after the delivery.
Participation in this study is voluntary and involves minimal risk. Allowing or not allowing cellphone use does not affect medical care in any way, and participants may withdraw at any time without any impact on their treatment. The results of this study may help hospitals improve patient-centered care and make cesarean deliveries a calmer and more positive experience for mothers and their families.
详细描述
Cesarean section performed under regional (spinal) anesthesia allows the mother to remain awake throughout the procedure, which can be associated with heightened anxiety, stress, and feelings of loss of control. While medical and surgical outcomes of cesarean delivery have been extensively studied, less attention has been given to modifiable, non-pharmacologic factors that may improve the psychological experience of the mother during surgery.
Personal mobile phones are an integral part of daily life and serve as a means of emotional support, reassurance, and connection. Allowing mothers to use their cellphones during cesarean section-such as communicating with family members, or engaging in video calls-may help reduce intraoperative anxiety and enhance maternal satisfaction. Despite this, many operating rooms maintain strict policies prohibiting cellphone use, largely based on tradition rather than evidence regarding patient-centered outcomes.
The CALMAS-CS Trial is a prospective, randomized, parallel-group study designed to evaluate the psychological impact of unrestricted personal cellphone use during elective cesarean section under spinal anesthesia. Participants are randomly assigned to either an intervention group, in which personal cellphone use is permitted throughout the procedure, or a control group, which follows standard operating room policy prohibiting cellphone use. All participants receive identical surgical, anesthetic, and perioperative care; the only difference between groups is access to personal cellphone use during surgery.
Maternal anxiety is assessed at predefined perioperative timepoints using validated instruments, including the State-Trait Anxiety Inventory and a visual analogue scale for anxiety. Maternal satisfaction with the cesarean experience is evaluated postoperatively using a structured questionnaire. In addition, the study explores the psychological impact on next of kin by assessing their stress levels and perceived involvement when remote communication during surgery is permitted.
This trial focuses on a low-risk, non-pharmacologic intervention that does not interfere with standard medical care. By systematically evaluating the psychological effects of cellphone access during cesarean delivery, the study aims to generate evidence that may inform future institutional policies and contribute to more patient-centered obstetric care. The findings may have implications for improving maternal experience, family engagement, and overall satisfaction with planned cesarean delivery.
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
盲法说明
Study statistician.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low-risk pregnant patients scheduled for Cesarean section under spinal anesthesia, who are literate and able to provide an informed consent.
排除标准
- •Patients undergoing normal vaginal deliveries.
- •Patients who underwent emergency Cesarean sections.
- •Non-Lebanese patients.
- •High-risk pregnancies, as determined by medical assessment.
- •Patients diagnosed with pre-existing anxiety disorders.
- •Patients for whom spinal anesthesia was difficult to perform (requiring more than two attempts for successful administration).
- •Patients receiving sedation during the procedure.
研究组 & 干预措施
Cell Phone Use
Participants assigned to this experimental arm will be allowed unrestricted use of their personal mobile phone during elective cesarean section performed under spinal anesthesia. Cellphone use is permitted throughout the intraoperative period and may include texting, voice or video calls, provided that use does not interfere with surgical sterility, patient monitoring, or clinical care. All anesthetic, surgical, and perioperative management will otherwise follow standard institutional protocols and will be identical to the control arm.
干预措施: Cell Phone Use (Behavioral)
Standard Care (No Cellphone Use)
Participants assigned to this control arm will undergo elective cesarean section under spinal anesthesia following standard operating room protocol, which does not allow access to personal mobile phones during the procedure. No communication with family members or next of kin will occur during the intraoperative period. All anesthetic, surgical, and perioperative care will be provided according to routine institutional practice and will be identical to that of the experimental arm, with the only difference being the absence of cellphone use.
结局指标
主要结局
Maternal Anxiety Levels During Elective Cesarean Section
时间窗: Preoperative (upon admission to the operating room), intraoperative (before and after delivery of the baby, and before skin closure), and postoperative (within 24 hours after cesarean section)
Maternal anxiety will be assessed using the Visual Analogue Scale for Anxiety (VAS-A). Anxiety scores will be measured at predefined perioperative timepoints to evaluate the effect of unrestricted personal cellphone use during elective cesarean section under spinal anesthesia. Higher scores indicate greater anxiety. The primary comparison will assess differences in anxiety levels between the intervention and control groups.
次要结局
- Maternal Postoperative Satisfaction(Within 24 hours after cesarean section)
- Next of Kin Stress Levels(Within 2 hours after cesarean section)
研究者
Bahaa Bou Dargham
Anesthesia & Reanimation Consultant / Lecturer of Anesthesia
Beirut Arab University