Caesarean SectionNCT07406607
The Effect of Presence of Father in the Operating Room on Quality of Recovery of the Parturient
A study testing Partner Presence in Operating Room in people with Caesarean Section, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Caesarean Section
- What is being tested?
- Partner Presence in Operating Room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2026to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: 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.
Read the 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.
- Conditions
- Caesarean Section
- Being tested
- Standard Care (No Partner Presence), Partner Presence in Operating Room
- Keywords
- spinal anesthesia, obstetric quality of recovery, Caesarean section, surgeon comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care (No Partner Presence)Other
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 RoomOther
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
| Study group | Role | What they receive |
|---|---|---|
| Partner Present | Experimental | Not described Receives: Other: Partner Presence in Operating Room |
| Partner Absent | Active comparator | Not described Receives: Other: Standard Care (No Partner Presence) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intra-operative (during the entire duration of the cesarean section)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start19 Feb 2026
- Primary completion10 Sep 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Savci, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406607
- Sponsor's protocol ID
- E-11095095-050.04-253322
- Status last verified
- Sep 2026
- First submitted
- 30 Dec 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
faruk
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Presence of Father During Elective Cesarean Section Under Spinal Anesthesia on Parturient's Quality of Recovery
- ClinicalTrials.gov ID
- NCT07406607
- Acronym / sponsor ID
- E-11095095-050.04-253322
- Conditions
- Caesarean Section
- Keywords
- spinal anesthesia, obstetric quality of recovery, Caesarean section, surgeon comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partner Present | Experimental | Other: Partner Presence in Operating Room |
| Partner Absent | Active comparator | Other: Standard Care (No Partner Presence) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 Absent |
| Partner Presence in Operating RoomThe 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 | Other | Partner Present |
Primary outcome
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.
1 secondary outcome
Surgeon's Physiological Stress Level (Heart Rate)
Time frame: Intra-operative (during the entire duration of the cesarean section)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publicationfaruk
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner Presence in Operating Room in people with Caesarean Section, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric Quality of Recovery-10 (ObsQoR-10) Score (time frame: Post-operative 24th hour,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07406607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.