Идёт набор NCT07406607

The Effect of Presence of Father in the Operating Room on Quality of Recovery of the Parturient

Без фазы С лечением Caesarean Section

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Standard Care (No Partner Presence), Partner Presence in Operating Room.
Кому может быть актуально: Состояния в реестре: Caesarean Section. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Presence of Father During Elective Cesarean Section Under Spinal Anesthesia on Parturient's Quality of Recovery

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Standard Care (No Partner Presence)
The patient undergoes the elective cesarean section according to standard hospital protocols. The partner is not present in the operating room during the surgery.
Другое Partner Presence in Operating Room
The patient's partner is admitted to the operating room after sterile preparations are complete. The partner remains with the patient to provide physical and emotional support during the cesarean section operation

Первичные конечные точки

Obstetric Quality of Recovery-10 (ObsQoR-10) Score [Срок оценки: Post-operative 24th hour,]

Вторичные конечные точки (1)

Surgeon's Physiological Stress Level (Heart Rate) [Срок оценки: Intra-operative (during the entire duration of the cesarean section)]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет