NCT07759726

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

January 5, 2026

Last Update Submit

August 9, 2026

Conditions

Keywords

Cesarean SectionSpinal AnesthesiaAnxietySatisfactionCellphoneMobile PhoneNon-Pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Within 24 hours after cesarean section

  • Next of Kin Stress Levels

    Within 2 hours after cesarean section

Study Arms (2)

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.

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.

Interventions

Cell Phone UseBEHAVIORAL

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.

Cell Phone Use

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Low-risk pregnant patients scheduled for Cesarean section under spinal anesthesia, who are literate and able to provide an informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammoud Hospital University Medical Center (HHUMC)

Sidon, Lebanon

Location

MeSH Terms

Conditions

Anxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • Bahaa W Bou Dargham, md

    Hammoud Hospital University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Study statistician.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia & Reanimation Consultant / Lecturer of Anesthesia

Study Record Dates

First Submitted

January 5, 2026

First Posted

August 12, 2026

Study Start

January 1, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations