← Back to all trials
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.)
Source: ClinicalTrials.gov (NCT07897331). StuddyBuddy aggregates publicly available trial information.