NCT07406607

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

December 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 19, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

December 30, 2025

Last Update Submit

February 19, 2026

Conditions

Caesarean Section

Keywords

spinal anesthesiaobstetric quality of recoveryCaesarean sectionsurgeon comfort

Outcome Measures

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.

    Post-operative 24th hour,

Secondary Outcomes (1)

  • Surgeon's Physiological Stress Level (Heart Rate)

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

Other Outcomes (1)

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

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

Study Arms (2)

Partner Present

EXPERIMENTAL
Other: Partner Presence in Operating Room

Partner Absent

ACTIVE COMPARATOR
Other: Standard Care (No Partner Presence)

Interventions

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 Absent
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

Partner Present

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • faruk

    RESULT

MeSH Terms

Interventions

Standard of CareOperating Rooms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Central Study Contacts

Gamze Savci, Asst. Prof

CONTACT

+905340695757gamzesavci42@gmail.com

Merve Olcenoglu, Asst. Prof

CONTACT

+905385648202merve41uyar@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All the data collected will be assessed by a masked outcome assessor.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

December 30, 2025

First Posted

February 12, 2026

Study Start

February 19, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 8, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

TU(1)