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

September 17, 2026 updated by: Gamze Savci, Karamanoğlu Mehmetbey University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Karaman, Turkey (Türkiye), 70200
        • Karaman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Partner Present
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
Active Comparator: Partner Absent
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-operative 24th hour,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon's Physiological Stress Level (Heart Rate)
Time Frame: Intra-operative (during the entire duration of the cesarean section)

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal and Partner Anxiety Levels (STAI-T and STAI-S)
Time Frame: Pre-operative and Post-operative (within the first 6 hours)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karamanoğlu Mehmetbey University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • faruk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Actual)

September 10, 2026

Study Completion (Actual)

September 17, 2026

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-11095095-050.04-253322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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