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

Official title

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

Overview

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.

Interventions

• Other 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.
• Other 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

Primary outcome measures

• Obstetric Quality of Recovery-10 (ObsQoR-10) Score [Time frame: Post-operative 24th hour,]

Secondary outcome measures (1)

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

Turkey (Türkiye) · 1 center

• Karaman Training and Research Hospital — Karaman

Publications

• faruk

Identifiers

NCT: NCT07406607 · E-11095095-050.04-253322

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗