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NCT07897331

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

Sponsor: Buca Seyfi Demirsoy State Hospital

View on ClinicalTrials.gov

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.

Official title: Association of Early Postoperative Heart Rate Variability and Sleep Parameters With Quality of Recovery After Cesarean Delivery: A Prospective Observational Cohort Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

82

Start Date

2026-11

Completion Date

2027-04

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DEVICE

Wearable-derived heart rate variability and sleep monitoring

Objective HRV, heart rate and sleep metrics derived from a consumer wrist wearable (Garmin Vivosmart 5) via the Fitrockr platform during the first 48 postoperative hours. Measurement only; no clinical intervention is assigned and device data do not inform clinical care.

Locations (1)

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

Izmir, Turkey (Türkiye)