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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorKaramanoğlu Mehmetbey University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Care (No Partner Presence)

    Other intervention

    The patient undergoes the elective cesarean section according to standard hospital protocols. The partner is not present in the operating room during the surgery.

  • Partner Presence in Operating Room

    Other intervention

    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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Partner PresentExperimental treatment 1 intervention
Group B: Partner AbsentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Obstetric Quality of Recovery-10 (ObsQoR-10) Score

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.

Time frame
Post-operative 24th hour,

Secondary outcomes

1

Surgeon's Physiological Stress Level (Heart Rate)

The operating surgeon's heart rate variability will be recorded using a rhythm Holter device during the surgery. A heart rate exceeding 100 beats per minute (bpm) will be considered an indicator of increased stress.

Time frame
Intra-operative (during the entire duration of the cesarean section)

Other outcomes

1

Maternal and Partner Anxiety Levels (STAI-T and STAI-S)

The State-Trait Anxiety Inventory (STAI) will be used to measure the patient's and partner's anxiety levels. Both the Trait (STAI-T) and State (STAI-S) components will be administered. Scores range from 20 to 80, with higher scores indicating greater anxiety.

Time frame
Pre-operative and Post-operative (within the first 6 hours)

Sponsors and contacts

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