AnxietyCALMAS-CSNCT07759726
Cellphone Access for Lowered Maternal Anxiety and Stress in Cesarean Sections
A study testing Cell Phone Use in people with Anxiety and Stress (Psychology), run by Beirut Arab University at 1 site in Lebanon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress (Psychology)
- What is being tested?
- Cell Phone Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low-risk pregnant patients scheduled for Cesarean section under spinal anesthesia, who are literate and able to provide an informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anxiety, Stress (Psychology)
- Being tested
- Cell Phone Use
- Keywords
- Cesarean Section, Spinal Anesthesia, Anxiety, Satisfaction, Cellphone, Mobile Phone, Non-Pharmacological Intervention
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell Phone UseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cell Phone Use | Experimental | 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. Receives: Behavioral: Cell Phone Use |
| Standard Care (No Cellphone Use) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Anxiety Levels During Elective 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.
Measured: 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)
Secondary outcomes (2)
Maternal Postoperative Satisfaction
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.
Measured: Within 24 hours after cesarean section
Next of Kin Stress Levels
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.
Measured: Within 2 hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Collaborators
- Hammoud Hospital University Medical Center
- Responsible party
- Principal investigator, Bahaa Bou Dargham, Beirut Arab University
- Investigators
- Bahaa W Bou Dargham, md, Principal investigator, Hammoud Hospital University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759726
- Sponsor's protocol ID
- IRB-Aug2024-XII
- Acronym
- CALMAS-CS
- Status last verified
- Aug 2026
- First submitted
- 5 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers outside the study team. This decision is based on institutional data protection policies, ethical considerations related to participant confidentiality, and the sensitive nature of psychological and perioperative data collected during childbirth. De-identified aggregate results will be reported through peer-reviewed publications and trial registry postings.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07759726
- Acronym / sponsor ID
- CALMAS-CS / IRB-Aug2024-XII
- Conditions
- Anxiety, Stress (Psychology)
- Keywords
- Cesarean Section, Spinal Anesthesia, Anxiety, Satisfaction, Cellphone, Mobile Phone, Non-Pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Collaborators
- Hammoud Hospital University Medical Center
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell Phone Use | Experimental | Behavioral: Cell Phone UseParticipants 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. |
| Standard Care (No Cellphone Use) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Low-risk pregnant patients scheduled for Cesarean section under spinal anesthesia, who are literate and able to provide an informed consent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell Phone UseParticipants 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. | Behavioural | Cell Phone Use |
Primary outcome
Maternal Anxiety Levels During Elective Cesarean Section
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.
2 secondary outcomes
Maternal Postoperative Satisfaction
Time frame: Within 24 hours after cesarean section
Next of Kin Stress Levels
Time frame: Within 2 hours after cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers outside the study team. This decision is based on institutional data protection policies, ethical considerations related to participant confidentiality, and the sensitive nature of psychological and perioperative data collected during childbirth. De-identified aggregate results will be reported through peer-reviewed publications and trial registry postings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahaa W Bou Dargham, md principal investigator
Hammoud Hospital University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Phone Use in people with Anxiety and Stress (Psychology), run by Beirut Arab University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Anxiety Levels During Elective Cesarean Section (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.