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Not Yet Recruiting NCT07897331

Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery

Conditions: Recovery of Function, Postoperative Period, Cesarean Section

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 82
Sponsor: Buca Seyfi Demirsoy State Hospital

Location: Buca Seyfi Demirsoy Training and Research Hospital, Department of Obstetrics and Gynecology Izmir

Summary

This prospective single-center observational cohort study investigates whether objectively measured early postoperative heart rate variability (HRV) and sleep parameters are associated with patient-reported quality of recovery after cesarean delivery. Women who deliver by cesarean section wear a consumer wrist device (Garmin Vívosmart 5) on the non-dominant wrist during the in-hospital period (first 48 hours). HRV metrics (e.g., RMSSD), continuous heart rate, and sleep are derived from raw beat-to-beat intervals via the Fitrockr platform. Quality of recovery is measured with the validated Turkish Obstetric Quality-of-Recovery score (ObsQoR-11T) at 24 and 48 hours, and subjective sleep with the Richards-Campbell Sleep Questionnaire (RCSQ). The primary hypothesis is that higher early HRV (particularly RMSSD) and better sleep are associated with higher ObsQoR-11T at postoperative day 1 (24 hours). The wearable is used for research purposes only and does not inform any clinical decision; routine care proceeds independently of the study.

Eligibility Criteria

Inclusion Criteria: * Women aged 18 years or older who delivered by cesarean section * Provided written informed consent * Clinically able to wear the wrist device throughout the first 48 postoperative hours Exclusion Criteria: * Known significant cardiac arrhythmia (e.g., atrial fibrillation) or a permanent pacemaker (invalidates HRV analysis) * Severe maternal complication requiring intensive care * Skin or limb condition precluding device placement * Inability to provide informed consent or to communicate (Conditions or medications that may substantially affect HRV are recorded and relevant cases excluded as needed.)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07897331). StuddyBuddy aggregates publicly available trial information.