Recovery of FunctionOtonom-CSNCT07897331

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

An observational study of Recovery of Function and Postoperative Period, run by Buca Seyfi Demirsoy State Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Recovery of Function, Postoperative Period, Cesarean Section
What is being tested?: Wearable-derived heart rate variability and sleep monitoring
Type of treatment: Medical device
How many people: 82 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Nov 2026to Apr 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Adult women delivering by cesarean section at a single tertiary obstetrics and gynecology clinic.

Who may be able to join

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

Who cannot join

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.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egehan Bilen, MD contact

+90 539 342 28 46

egehanbilen@gmail.com

Turkey (Türkiye)1 site

Buca Seyfi Demirsoy Training and Research Hospital, Department of Obstetrics and Gynecology
Izmir, 35390

Other trials in Turkey (Türkiye)

About this 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

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.

Read the detailed description

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:

H1: Higher early HRV (e.g., RMSSD, HF power) is associated with better ObsQoR-11T score.
H2: Shorter / more fragmented sleep (sleep duration, efficiency, number of awakenings) is associated with lower ObsQoR-11T score.

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.

Conditions: Recovery of Function, Postoperative Period, Cesarean Section
Being tested: Wearable-derived heart rate variability and sleep monitoring
Keywords: Heart Rate Variability, Sleep, Wearable Device, Quality of Recovery, ObsQoR-11T, Richards-Campbell Sleep Questionnaire, Cesarean Delivery, Autonomic Function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wearable-derived heart rate variability and sleep monitoringDevice
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.

Study groups in NCT07897331
Study group	Role	What they receive
Women after cesarean delivery		Adult women who delivered by cesarean section, monitored with a wrist-worn wearable (Garmin Vívosmart 5) for the first 48 postoperative hours. Receives: Device: Wearable-derived heart rate variability and sleep monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: First 24 hours postpartum

Secondary outcomes (23)

ObsQoR-11T total score
Obstetric Quality of Recovery score, validated Turkish version (ObsQoR-11T); 11 items, total range 0-110 (higher = better recovery).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First and second postoperative nights (within 48 hours after cesarean delivery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2026Apr 2027

First posted27 Oct 2026
Study startNov 2026 (estimated)
Primary completionApr 2027 (estimated)
Study completionApr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Recovery of FunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 82 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07897331
Sponsor's protocol ID: Otonom-CS
Other IDs: 2026/09-130
Acronym: Otonom-CS
Status last verified: Oct 2026
First submitted: 13 Oct 2026
Last updated: 2 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Karaman Ozlu Z, Ozer N. Richard-Campbell Sleep Questionnaire validity and reliability study [Richard-Campbell Uyku Olcegi Gecerlilik ve Guvenilirlik Calismasi]. J Turk Sleep Med. 2015;2(2):29-32. doi:10.4274/jtsm.02.008
Georgiou K, Larentzakis AV, Khamis NN, Alsuhaibani GI, Alaska YA, Giallafos EJ. Can Wearable Devices Accurately Measure Heart Rate Variability? A Systematic Review. Folia Med (Plovdiv). 2018 Mar 1;60(1):7-20. doi: 10.2478/folmed-2018-0012.
PubMed 29668452
Miller DJ, Sargent C, Roach GD. A Validation of Six Wearable Devices for Estimating Sleep, Heart Rate and Heart Rate Variability in Healthy Adults. Sensors (Basel). 2022 Aug 22;22(16):6317. doi: 10.3390/s22166317.
PubMed 36016077
Dial MB, Hollander ME, Vatne EA, Emerson AM, Edwards NA, Hagen JA. Validation of nocturnal resting heart rate and heart rate variability in consumer wearables. Physiol Rep. 2025 Aug;13(16):e70527. doi: 10.14814/phy2.70527.
PubMed 40834291
Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PubMed 11227580
Schyvens AM, Peters B, Van Oost NC, Aerts JM, Masci F, Neven A, Dirix H, Wets G, Ross V, Verbraecken J. A performance validation of six commercial wrist-worn wearable sleep-tracking devices for sleep stage scoring compared to polysomnography. Sleep Adv. 2025 Mar 22;6(2):zpaf021. doi: 10.1093/sleepadvances/zpaf021. eCollection 2025 Apr.
PubMed 40303381
Gielen J, Van Oost CN, Debard G, Sels R, De Witte NAJ, Colman T, Bonroy B, Aerts JM. Accuracy of Optical Heart Rate Measurements for 10 Commercial Wearables in Different Climate Conditions and Activities: Instrument Validation Study. JMIR Form Res. 2026 Feb 17;10:e85186. doi: 10.2196/85186.
PubMed 41701929
Ozkan G, Kara U, Ince ME, Ozdemir O, Ulubay M, Senkal S. Validation of the Turkish version of the Obstetric Quality-of-Recovery score 11 (ObsQoR-11T) after cesarean delivery. Health Qual Life Outcomes. 2022 Nov 28;20(1):155. doi: 10.1186/s12955-022-02073-y.
PubMed 36443784
Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
PubMed 30579408

Interested in taking part?

Egehan Bilen, MD

+90 539 342 28 46

egehanbilen@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association of Early Postoperative Heart Rate Variability and Sleep Parameters With Quality of Recovery After Cesarean Delivery: A Prospective Observational Cohort Study
ClinicalTrials.gov ID: NCT07897331
Acronym / sponsor ID: Otonom-CS / Otonom-CS
Conditions: Recovery of Function, Postoperative Period, Cesarean Section
Keywords: Heart Rate Variability, Sleep, Wearable Device, Quality of Recovery, ObsQoR-11T, Richards-Campbell Sleep Questionnaire, Cesarean Delivery, Autonomic Function
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 82 participants (estimated)
Lead sponsor: Buca Seyfi Demirsoy State HospitalUniversity, hospital or other
Study start: Nov 2026 (estimated)
Primary completion: Apr 2027 (estimated)
Study completion: Apr 2027 (estimated)
First posted: 27 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives / Hypotheses:

H1: Higher early HRV (e.g., RMSSD, HF power) is associated with better ObsQoR-11T score.
H2: Shorter / more fragmented sleep (sleep duration, efficiency, number of awakenings) is associated with lower ObsQoR-11T score.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Women after cesarean delivery	–	Device: Wearable-derived heart rate variability and sleep monitoringAdult women who delivered by cesarean section, monitored with a wrist-worn wearable (Garmin Vívosmart 5) for the first 48 postoperative hours.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult women delivering by cesarean section at a single tertiary obstetrics and gynecology clinic.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Wearable-derived heart rate variability and sleep monitoringObjective 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.	Device	Women after cesarean delivery

Primary outcome

Correlation between early heart rate variability (ln RMSSD) and quality of recovery (ObsQoR-11T)
Time frame: 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.

23 secondary outcomes

ObsQoR-11T total score
Time frame: 24 and 48 hours postpartum
Subjective sleep quality (Richards-Campbell Sleep Questionnaire, RCSQ)
Time frame: 24 and 48 hours postpartum
Standard deviation of NN intervals (SDNN)
Time frame: First 48 hours after cesarean delivery
Proportion of successive NN intervals differing by more than 50 ms (pNN50)
Time frame: First 48 hours after cesarean delivery
Low-frequency power of heart rate variability (LF)
Time frame: First 48 hours after cesarean delivery
High-frequency power of heart rate variability (HF)
Time frame: First 48 hours after cesarean delivery
Ratio of low-frequency to high-frequency power (LF/HF)
Time frame: First 48 hours after cesarean delivery
Ratio of Poincare plot descriptors SD1 to SD2
Time frame: First 48 hours after cesarean delivery
Natural log of RMSSD at fixed postoperative time windows
Time frame: 12, 24, 36 and 48 hours after cesarean delivery
Mean heart rate at fixed postoperative time windows
Time frame: 12, 24, 36 and 48 hours after cesarean delivery
Total sleep time measured by the wearable device
Time frame: First 48 hours after cesarean delivery
Sleep efficiency measured by the wearable device
Time frame: First 48 hours after cesarean delivery
Number of awakenings measured by the wearable device
Time frame: First 48 hours after cesarean delivery
Agreement between objective (device) and subjective (RCSQ) sleep
Time frame: First 48 hours postpartum
Pain at rest on a numeric rating scale
Time frame: 24 and 48 hours after cesarean delivery
Pain on movement on a numeric rating scale
Time frame: 24 and 48 hours after cesarean delivery
Total opioid consumption in oral morphine milligram equivalents
Time frame: First 48 hours after cesarean delivery
Change in ObsQoR-11T from 24 to 48 hours
Time frame: 24 to 48 hours postpartum
Mean device-derived stress score
Time frame: First 48 hours after cesarean delivery
Proportion of valid wear time in the rest stress state
Time frame: First 48 hours after cesarean delivery
Number of stress episodes per 24 hours
Time frame: First 48 hours after cesarean delivery
Median stress recovery time after stress episodes
Time frame: First 48 hours after cesarean delivery
Overnight Body Battery charge
Time frame: First and second postoperative nights (within 48 hours after cesarean delivery)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
BackgroundKaraman Ozlu Z, Ozer N. Richard-Campbell Sleep Questionnaire validity and reliability study [Richard-Campbell Uyku Olcegi Gecerlilik ve Guvenilirlik Calismasi]. J Turk Sleep Med. 2015;2(2):29-32. doi:10.4274/jtsm.02.008
Background: PubMed 29668452Georgiou K, Larentzakis AV, Khamis NN, Alsuhaibani GI, Alaska YA, Giallafos EJ. Can Wearable Devices Accurately Measure Heart Rate Variability? A Systematic Review. Folia Med (Plovdiv). 2018 Mar 1;60(1):7-20. doi: 10.2478/folmed-2018-0012.
Background: PubMed 36016077Miller DJ, Sargent C, Roach GD. A Validation of Six Wearable Devices for Estimating Sleep, Heart Rate and Heart Rate Variability in Healthy Adults. Sensors (Basel). 2022 Aug 22;22(16):6317. doi: 10.3390/s22166317.
Background: PubMed 40834291Dial MB, Hollander ME, Vatne EA, Emerson AM, Edwards NA, Hagen JA. Validation of nocturnal resting heart rate and heart rate variability in consumer wearables. Physiol Rep. 2025 Aug;13(16):e70527. doi: 10.14814/phy2.70527.
Background: PubMed 11227580Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
Background: PubMed 40303381Schyvens AM, Peters B, Van Oost NC, Aerts JM, Masci F, Neven A, Dirix H, Wets G, Ross V, Verbraecken J. A performance validation of six commercial wrist-worn wearable sleep-tracking devices for sleep stage scoring compared to polysomnography. Sleep Adv. 2025 Mar 22;6(2):zpaf021. doi: 10.1093/sleepadvances/zpaf021. eCollection 2025 Apr.
Background: PubMed 41701929Gielen J, Van Oost CN, Debard G, Sels R, De Witte NAJ, Colman T, Bonroy B, Aerts JM. Accuracy of Optical Heart Rate Measurements for 10 Commercial Wearables in Different Climate Conditions and Activities: Instrument Validation Study. JMIR Form Res. 2026 Feb 17;10:e85186. doi: 10.2196/85186.
Background: PubMed 36443784Ozkan G, Kara U, Ince ME, Ozdemir O, Ulubay M, Senkal S. Validation of the Turkish version of the Obstetric Quality-of-Recovery score 11 (ObsQoR-11T) after cesarean delivery. Health Qual Life Outcomes. 2022 Nov 28;20(1):155. doi: 10.1186/s12955-022-02073-y.
Background: PubMed 30579408Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
Garmin Enhanced Beat-to-Beat Interval (BBI) technical documentLink provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Egehan Bilen, MD contact

+90 539 342 28 46

egehanbilen@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Recovery of Function and Postoperative Period, run by Buca Seyfi Demirsoy State Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Egehan Bilen, MD (+90 539 342 28 46, egehanbilen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between early heart rate variability (ln RMSSD) and quality of recovery (ObsQoR-11T) (time frame: First 24 hours postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07897331, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.