Father present in the operating room during elective cesarean and maternal recovery
The Effect of Presence of Father During Elective Cesarean Section Under Spinal Anesthesia on Parturient's Quality of Recovery
This trial tests whether having the baby's father in the operating room during an elective cesarean helps mothers recover better and feel less anxious after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Karamanoğlu Mehmetbey University Academic / other |
| Locations | 1 site (Karaman) |
| Trial ID | NCT07406607 on ClinicalTrials.gov |
What this trial studies
This prospective interventional study compares elective cesarean patients whose partners are allowed into the operating room with patients whose partners are not present. All procedures use spinal anesthesia and patients are allocated to Partner Present or Partner Absent groups, with the operating surgeon required to have at least five years' experience. The primary outcome is the obstetric quality of recovery score (ObsQoR-10) on postoperative day 1, and secondary outcomes include pain (VAS every 6 hours for the first 24 hours), anxiety measured by STAI in both partners preoperatively and postoperatively, and ObsQoR-10 on postoperative days 3 and 7. Participants and their partners must be literate in Turkish and the study is conducted at Karaman Training and Research Hospital.
Who should consider this trial
Good fit: Healthy pregnant women scheduled for elective cesarean under spinal anesthesia who are ASA class 1–2, have a Turkish-literate partner willing to be present, and whose surgeon meets the experience requirement.
Not a fit: Patients having emergency cesareans, those with significant chronic illnesses or ASA ≥3, or those without a Turkish-literate willing partner are unlikely to qualify or benefit from this intervention.
Why it matters
Potential benefit: If successful, allowing partners into the operating room could reduce maternal anxiety and improve early postoperative recovery after elective cesarean.
How similar studies have performed: Partner presence during childbirth is widely practiced and associated with psychosocial benefits in prior research, but randomized data linking partner presence to formal recovery scores like ObsQoR-10 are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for an elective cesarean section. * Patients and their partners must be literate in Turkish (able to read and write) to accurately complete the study questionnaires * Patients and their partners must be willing and able to provide written informed consent * Healthy pregnant women with no additional chronic or systemic diseases (comorbidities) * The operating surgeon must have at least 5 years of professional experience and no chronic health conditions. Exclusion Criteria: * Patients undergoing emergency cesarean sections. * Patients with any known chronic or systemic additional diseases * Surgeons with any known chronic or systemic diseases. * Individuals unable to read or understand the Turkish questionnaires (implied by the literacy requirement). * Patients with American Society of Anesthesiologists (ASA) classification of 3 or more * Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse * Patients who have refused spinal anesthesia, or those in whom it is contraindicated. * Pregnancy with preeclampsia or eclampsia * Pregnancy with gestational diabetes mellitus or diabetes mellitus
Where this trial is running
Karaman
- Karaman Training and Research Hospital — Karaman, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Gamze Savci, Asst. Prof
- Email: gamzesavci42@gmail.com
- Phone: +905340695757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.