- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406607
The Effect of Presence of Father in the Operating Room on Quality of Recovery of the Parturient
February 19, 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
Recruiting
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 (Estimated)
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 Contact
- Name: Gamze Savci, Asst. Prof
- Phone Number: +905340695757
- Email: gamzesavci42@gmail.com
Study Contact Backup
- Name: Merve Olcenoglu, Asst. Prof
- Phone Number: +905385648202
- Email: merve41uyar@hotmail.com
Study Locations
-
-
-
Karaman, Turkey (Türkiye), 70200
- Recruiting
- Karaman Training and Research Hospital
-
Contact:
- Gamze Savci, Asst. Prof
- Phone Number: +905340695757
- Email: gamzesavci42@gmail.com
-
-
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
- Adult
Accepts Healthy Volunteers
No
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
|
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
|
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
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 (Estimated)
June 1, 2026
Study Completion (Estimated)
June 8, 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)
February 20, 2026
Last Update Submitted That Met QC Criteria
February 19, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
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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