The Effect of Presence of Father During Elective Cesarean Section Under Spinal Anesthesia on Parturient's Quality of Recovery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Obstetric Quality of Recovery-10 (ObsQoR-10) Score
Study Overview
Brief Summary
The presence of a partner to support the mother during cesarean and vaginal deliveries is a well-established practice in most countries worldwide. It is evident that allowing the partner into the operating room during a cesarean section provides psychosocial benefits for both the mother and the partner. This study aims to investigate the effect of the presence of partner in the operating room on quality of recovery of parturients at the postoperative period.
Detailed Description
This prospective study evaluates the impact of the partner's presence in the operating room during elective cesarean sections on maternal anxiety, postoperative recovery, and surgeon stress levels. Patients are allocated into two groups: Partner Present and Partner Absent. Primary outcome is obstetric quality of recovery scale (ObsQoR 10) at the postoperative first day. Secondary outcomes include maternal pain (assessed via VAS at 6-hour intervals for the first 24 hours) and anxiety levels (STAI-T/S administered to couples preoperatively and STAI-S postoperatively) and ObsQoR-10 that will be evaluated at the postoperative 3rd and 7th days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Masking Description
All the data collected will be assessed by a masked outcome assessor.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Partner Present
Intervention: Partner Presence in Operating Room (Other)
Partner Absent
Intervention: Standard Care (No Partner Presence) (Other)
Outcomes
Primary Outcomes
Obstetric Quality of Recovery-10 (ObsQoR-10) Score
Time Frame: Post-operative 24th hour,
The ObsQoR-10 questionnaire will be used to assess the quality of maternal recovery after the cesarean section. The scale consists of 10 items, where patients rate each item from 0 (never) to 10 (always). Higher scores indicate a better quality of recovery.
Secondary Outcomes
- Surgeon's Physiological Stress Level (Heart Rate)(Intra-operative (during the entire duration of the cesarean section))
Investigators
Gamze Savci
Asst. Prof
Karamanoğlu Mehmetbey University