Hammoud Hospital University Medical Center (HHUMC)
Sidon, Lebanon
NCT Number: NCT07759726
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Sidon, Lebanon
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Within 24 hours after cesarean section
Maternal satisfaction with the cesarean section experience will be assessed using a structured self-administered questionnaire adapted from validated satisfaction instruments. The questionnaire evaluates overall satisfaction with the surgical experience, communication, emotional support, and perceived quality of care. Higher scores indicate greater satisfaction.
Time frame: Within 2 hours after cesarean section
Stress levels of the participant's next of kin will be assessed using a Visual Analogue Scale for Stress (VAS-S), a self-reported scale ranging from 0 (no stress) to 10 (extreme stress). This outcome evaluates whether intraoperative communication via cellphone use influences perceived stress among family members.
Beirut Arab University
Other
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
Acronym: CALMAS-CS
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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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