Trial · NCT07897331
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Correlation between early heart rate variability (ln RMSSD) and quality of recovery (ObsQoR-11T) | First 24 hours postpartum | 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. |
| Secondary | ObsQoR-11T total score | 24 and 48 hours postpartum | Obstetric Quality of Recovery score, validated Turkish version (ObsQoR-11T); 11 items, total range 0-110 (higher = better recovery). |
| Secondary | Subjective sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ) | 24 and 48 hours postpartum | RCSQ total score, calculated as the mean of the first 5 items (range 0-100; higher = better sleep). |
| Secondary | Standard deviation of NN intervals (SDNN) | First 48 hours after cesarean delivery | 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. |
| Secondary | Proportion of successive NN intervals differing by more than 50 ms (pNN50) | First 48 hours after cesarean delivery | 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. |
| Secondary | Low-frequency power of heart rate variability (LF) | First 48 hours after cesarean delivery | 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. |
| Secondary | High-frequency power of heart rate variability (HF) | First 48 hours after cesarean delivery | 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. |
| Secondary | Ratio of low-frequency to high-frequency power (LF/HF) | First 48 hours after cesarean delivery | 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. |
| Secondary | Ratio of Poincare plot descriptors SD1 to SD2 | First 48 hours after cesarean delivery | 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. |
| Secondary | Natural log of RMSSD at fixed postoperative time windows | 12, 24, 36 and 48 hours after cesarean delivery | 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). |
| Secondary | Mean heart rate at fixed postoperative time windows | 12, 24, 36 and 48 hours after cesarean delivery | 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. |
| Secondary | Total sleep time measured by the wearable device | First 48 hours after cesarean delivery | Total sleep time derived from the wrist-worn wearable (Garmin Vivosmart 5) via the Fitrockr platform, reported in minutes. |
| Secondary | Sleep efficiency measured by the wearable device | First 48 hours after cesarean delivery | 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. |
| Secondary | Number of awakenings measured by the wearable device | First 48 hours after cesarean delivery | Count of awakenings during the sleep period, derived from the wrist-worn wearable (Garmin Vivosmart 5) via the Fitrockr platform. |
| Secondary | Agreement between objective (device) and subjective (RCSQ) sleep | First 48 hours postpartum | Correlation/agreement between wearable-derived sleep parameters and the RCSQ score. |
| Secondary | Pain at rest on a numeric rating scale | 24 and 48 hours after cesarean delivery | 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. |
| Secondary | Pain on movement on a numeric rating scale | 24 and 48 hours after cesarean delivery | 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. |
| Secondary | Total opioid consumption in oral morphine milligram equivalents | First 48 hours after cesarean delivery | Cumulative opioid dose administered after cesarean delivery, converted to oral morphine milligram equivalents and recorded from the medication chart. |
| Secondary | Change in ObsQoR-11T from 24 to 48 hours | 24 to 48 hours postpartum | 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. |
| Secondary | Mean device-derived stress score | First 48 hours after cesarean delivery | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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