The Effect of Presence of Father During Elective Cesarean Section Under Spinal Anesthesia on Parturient's Quality of Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Obstetric Quality of Recovery-10 (ObsQoR-10) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
All the data collected will be assessed by a masked outcome assessor.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Partner Present
干预措施: Partner Presence in Operating Room (Other)
Partner Absent
干预措施: Standard Care (No Partner Presence) (Other)
结局指标
主要结局
Obstetric Quality of Recovery-10 (ObsQoR-10) Score
时间窗: 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.
次要结局
- Surgeon's Physiological Stress Level (Heart Rate)(Intra-operative (during the entire duration of the cesarean section))
研究者
Gamze Savci
Asst. Prof
Karamanoğlu Mehmetbey University