An observational study in Recovery of Function, Postoperative Period and Cesarean Section, sponsored by Buca Seyfi Demirsoy State Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Buca Seyfi Demirsoy State Hospital · Observational
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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.
Background: Cesarean section is among the most common surgical procedures, and objective assessment of postpartum recovery may help improve quality of care. Wearable-derived autonomic (HRV) and sleep measures are candidate objective correlates of recovery but have not been characterized in the early in-hospital cesarean period.
Objectives / Hypotheses:
Procedures: Consenting women receive a Garmin Vívosmart 5 on the non-dominant wrist immediately postoperatively; the device remains in hospital only (\~48 hours) and is disinfected/recharged between patients. Raw beat-to-beat intervals and computed HRV metrics (RMSSD, SDNN, pNN50, LF, HF, LF/HF, SD1/SD2), continuous heart rate, sleep, and minute-level device-derived stress scores and Body Battery are obtained from the Fitrockr platform. Patient-reported outcomes (ObsQoR-11T, RCSQ, numeric rating scale [NRS] pain) and clinical/demographic data are collected via a case report form at 24 and 48 hours.
HRV analysis windows and signal-quality criteria: nocturnal 5-minute stable segments at fixed hours; beats deviating >20% from neighboring intervals are corrected/removed; a segment is analyzable if the corrected/removed beat proportion is ≤5%; the primary window (first 24 hours) requires at least one valid nocturnal segment and ≥80% device wear time within the window.
Statistics: The primary analysis is the association between early (first 24 hours) ln RMSSD and ObsQoR-11T at 24 hours, using Pearson or Spearman correlation according to distribution, with adjustment for age, body mass index, and anesthesia type. The single pre-specified primary test is reported without multiplicity correction; secondary/exploratory analyses apply Benjamini-Hochberg false discovery rate control (q\<0.05). Missing data: complete-case for the primary analysis, with multiple-imputation sensitivity analysis. Device-derived stress and Body Battery outcomes are secondary, exploratory measures; because both are derived from heart rate variability, they are not independent of the primary exposure (ln RMSSD) and will be reported descriptively and in exploratory correlation analyses. The proportion of valid minutes will be reported for each participant.
Buca Seyfi Demirsoy State Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult women delivering by cesarean section at a single tertiary obstetrics and gynecology clinic.
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Exclusion Criteria:
(Conditions or medications that may substantially affect HRV are recorded and relevant cases excluded as needed.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult women who delivered by cesarean section, monitored with a wrist-worn wearable (Garmin Vívosmart 5) for the first 48 postoperative hours.
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.
Correlation between early heart rate variability (ln RMSSD) and quality of recovery (ObsQoR-11T)
Correlation (Pearson or Spearman, per distribution) between early postoperative HRV (natural log of RMSSD over the first 24 hours) and the ObsQoR-11T total score (range 0-110; higher = better recovery) at 24 hours postpartum.
Time frame: First 24 hours postpartum
ObsQoR-11T total score
Obstetric Quality of Recovery score, validated Turkish version (ObsQoR-11T); 11 items, total range 0-110 (higher = better recovery).
Time frame: 24 and 48 hours postpartum
Subjective sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ)
RCSQ total score, calculated as the mean of the first 5 items (range 0-100; higher = better sleep).
Time frame: 24 and 48 hours postpartum
Standard deviation of NN intervals (SDNN)
Time-domain heart rate variability computed from raw beat-to-beat intervals recorded by a wrist-worn wearable (Garmin Vivosmart 5) and processed on the Fitrockr platform. Reported in milliseconds from analyzable nocturnal 5-minute segments.
Time frame: First 48 hours after cesarean delivery
Proportion of successive NN intervals differing by more than 50 ms (pNN50)
Time-domain heart rate variability computed from raw beat-to-beat intervals recorded by a wrist-worn wearable (Garmin Vivosmart 5) and processed on the Fitrockr platform. Reported as a percentage of successive interval pairs from analyzable nocturnal 5-minute segments.
Time frame: First 48 hours after cesarean delivery
Low-frequency power of heart rate variability (LF)
Frequency-domain heart rate variability (0.04-0.15 Hz) computed from raw beat-to-beat intervals recorded by a wrist-worn wearable (Garmin Vivosmart 5) and processed on the Fitrockr platform. Reported as absolute power in squared milliseconds from analyzable nocturnal 5-minute segments.
Time frame: First 48 hours after cesarean delivery
High-frequency power of heart rate variability (HF)
Frequency-domain heart rate variability (0.15-0.40 Hz) computed from raw beat-to-beat intervals recorded by a wrist-worn wearable (Garmin Vivosmart 5) and processed on the Fitrockr platform. Reported as absolute power in squared milliseconds from analyzable nocturnal 5-minute segments.
Time frame: First 48 hours after cesarean delivery
Ratio of low-frequency to high-frequency power (LF/HF)
Ratio of absolute low-frequency to high-frequency heart rate variability power, computed from raw beat-to-beat intervals recorded by a wrist-worn wearable (Garmin Vivosmart 5) and processed on the Fitrockr platform. Reported as a unitless ratio from analyzable nocturnal 5-minute segments.
Time frame: First 48 hours after cesarean delivery
Ratio of Poincare plot descriptors SD1 to SD2
Non-linear heart rate variability index computed from raw beat-to-beat intervals recorded by a wrist-worn wearable (Garmin Vivosmart 5) and processed on the Fitrockr platform. Reported as a unitless ratio from analyzable nocturnal 5-minute segments.
Time frame: First 48 hours after cesarean delivery
Natural log of RMSSD at fixed postoperative time windows
Natural logarithm of the root mean square of successive beat-to-beat interval differences, computed from raw beat-to-beat intervals recorded by a wrist-worn wearable (Garmin Vivosmart 5) and processed on the Fitrockr platform, at fixed postoperative windows. Reported as ln(ms).
Time frame: 12, 24, 36 and 48 hours after cesarean delivery
Mean heart rate at fixed postoperative time windows
Mean heart rate derived from the wrist-worn wearable (Garmin Vivosmart 5) via the Fitrockr platform at fixed postoperative windows, reported in beats per minute.
Time frame: 12, 24, 36 and 48 hours after cesarean delivery
Total sleep time measured by the wearable device
Total sleep time derived from the wrist-worn wearable (Garmin Vivosmart 5) via the Fitrockr platform, reported in minutes.
Time frame: First 48 hours after cesarean delivery
Sleep efficiency measured by the wearable device
Total sleep time divided by time in bed, derived from the wrist-worn wearable (Garmin Vivosmart 5) via the Fitrockr platform and reported as a percentage.
Time frame: First 48 hours after cesarean delivery
Number of awakenings measured by the wearable device
Count of awakenings during the sleep period, derived from the wrist-worn wearable (Garmin Vivosmart 5) via the Fitrockr platform.
Time frame: First 48 hours after cesarean delivery
Agreement between objective (device) and subjective (RCSQ) sleep
Correlation/agreement between wearable-derived sleep parameters and the RCSQ score.
Time frame: First 48 hours postpartum
Pain at rest on a numeric rating scale
Patient-reported pain intensity at rest on a numeric rating scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain.
Time frame: 24 and 48 hours after cesarean delivery
Pain on movement on a numeric rating scale
Patient-reported pain intensity on movement on a numeric rating scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain.
Time frame: 24 and 48 hours after cesarean delivery
Total opioid consumption in oral morphine milligram equivalents
Cumulative opioid dose administered after cesarean delivery, converted to oral morphine milligram equivalents and recorded from the medication chart.
Time frame: First 48 hours after cesarean delivery
Change in ObsQoR-11T from 24 to 48 hours
Difference in ObsQoR-11T total score (range 0-110; higher = better recovery) between 24 and 48 hours postpartum, and its association with early HRV and sleep.
Time frame: 24 to 48 hours postpartum
Mean device-derived stress score
Mean of minute-level stress scores recorded by the wrist-worn wearable (Garmin Vivosmart 5; proprietary 0-100 scale derived from heart rate variability, higher values indicate greater physiological stress) and exported via the Fitrockr platform, averaged over all valid minutes. Reported as score units on a 0-100 scale.
Time frame: First 48 hours after cesarean delivery
Proportion of valid wear time in the rest stress state
Percentage of valid minutes in which the wrist-worn wearable (Garmin Vivosmart 5) recorded a stress score of 0-25 (rest state on the device's proprietary 0-100 scale), exported via the Fitrockr platform.
Time frame: First 48 hours after cesarean delivery
Number of stress episodes per 24 hours
Number of episodes of at least 3 consecutive minutes with a device-derived stress score above 50 (medium or high stress on the Garmin Vivosmart 5 proprietary 0-100 scale), exported via the Fitrockr platform and normalized to episodes per 24 hours of valid wear time.
Time frame: First 48 hours after cesarean delivery
Median stress recovery time after stress episodes
Median time in minutes from the end of each stress episode (at least 3 consecutive minutes with a device-derived stress score above 50) to the first subsequent minute with a stress score of 25 or below (rest state), computed from minute-level Garmin Vivosmart 5 stress scores exported via the Fitrockr platform.
Time frame: First 48 hours after cesarean delivery
Overnight Body Battery charge
Change in the device-derived Body Battery energy score (Garmin Vivosmart 5; proprietary 0-100 scale estimated from heart rate variability, stress, sleep and activity) from the start to the end of the main nocturnal sleep period detected by the device, exported via the Fitrockr platform. Reported as score units on a 0-100 scale; positive values indicate recharge.
Time frame: First and second postoperative nights (within 48 hours after cesarean delivery)
Plan to share: Yes — De-identified individual participant data (heart rate variability, sleep and outcome variables) underlying the reported results may be made available from the corresponding author on reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months and ending 5 years after publication of the main results.
Access criteria: Requests from qualified researchers with a methodologically sound proposal, submitted to the corresponding author. A data access agreement is required, and sharing is subject to approval by the principal investigator and compliance with applicable data protection law.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Buca Seyfi Demirsoy State Hospital