Smartwatch Accuracy for Measuring Vitals and Anxiety Before Disc Surgery

December 22, 2025 updated by: Halil Kalaycı

Validation of Smartwatch Technology for Preoperative Monitoring of Sleep Quality, Anxiety, and Vital Signs in Patients Undergoing Disc Herniation Surgery

This study aims to verify the accuracy of blood pressure, heart rate, blood oxygen saturation, anxiety level, and sleep cycle data measurements obtained from Samsung smartwatches compared to the currently accepted method used in patients with disc herniation undergoing the preoperative period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population comprises adult inpatients admitted to the Neurosurgical Ward of the university hospital due to intervertebral disc herniation for preoperative assessment and monitoring.

Description

Inclusion Criteria:

  • 22 years and older
  • Currently receiving preoperative care/assessment for disc herniation surgery.
  • No history of any cardiovascular disease other than controlled hypertension.
  • Willingness to wear the smartwatch for a minimum of 8 consecutive hours during the night before surgery.
  • Ability to follow all instructions related to the smartwatch operation and data collection independently.
  • No known allergy to nickel.

Exclusion Criteria:

  • Patients who are currently receiving prescribed medication specifically for sleep in the clinical setting.
  • Refusal or unwillingness to participate in the study.
  • The participant fails to wear the smartwatch correctly or appropriately as per study instructions, leading to incomplete or unreliable data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Preoperative Disc Herniation Patients
This group consists of hospitalized adult patients scheduled for intervertebral disc herniation surgery whose preliminary examinations are complete. Measurements will be taken at two different time points: the night before surgery and the morning of the surgery. Patients' vital signs (blood pressure, pulse, oxygen saturation) will be determined using standard medical devices, while anxiety and sleep quality will be determined via validated clinical scales. All these values will be collected simultaneously using smartwatches (Samsung).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Pressure (BP) (Medical-Grade)
Time Frame: Evening before surgery; Morning before surgery.
One measurement will be taken from both the patient's right and left arm using a calibrated medical-grade sphygmomanometer (BP cuff) at each time point. Both systolic and diastolic pressure will be recorded separately.
Evening before surgery; Morning before surgery.
Heart Rate (HR) (Medical-Grade)
Time Frame: Evening before surgery; Morning before surgery.
HR will be taken using a finger pulse oximeter on the finger of the same arm as the smartwatch at each time point.
Evening before surgery; Morning before surgery.
Blood Oxygen Saturation (SpO2) (Medical-Grade)
Time Frame: Evening before surgery; Morning before surgery.
SpO2 will be taken using a finger pulse oximeter on the finger of the same arm as the smartwatch at each time point.
Evening before surgery; Morning before surgery.
State-Trait Anxiety Inventory (STAI) Score
Time Frame: Evening before surgery; Morning before surgery.
The evening before surgery: Both the State-Trait Anxiety Inventory (STAI) State and Trait anxiety scores will be recorded. The morning before surgery: Only the State Anxiety Inventory score will be recorded. Both the State and Trait forms of the STAI include reverse-scored items. Total scores are calculated for each form, with higher scores reflecting higher levels of anxiety.
Evening before surgery; Morning before surgery.
Richards-Campbell Sleep Questionnaire (RCSQ) Score
Time Frame: Evening before surgery; Morning before surgery
Sleep quality will be measured twice using the Richards-Campbell Sleep Questionnaire (RCSQ): 1) The evening before surgery, to assess the night immediately before the decision to operate. 2) The morning before surgery, assess the preoperative night spent in the hospital. The total score is calculated using the first five items of the scale, with the noise item excluded from scoring. Scores of 0-25 indicate very poor sleep, while scores of 76-100 indicate very good sleep.
Evening before surgery; Morning before surgery
Blood Pressure (BP) (Measured via Wrist)
Time Frame: Evening before surgery; Morning before surgery.
Blood pressure will be measured using a smartwatch twice: once on the evening before surgery and once on the morning of surgery. On both occasions, the smartwatch-based measurement will be obtained immediately prior to the medical blood pressure measurement. All measurements will be obtained from the same preoperatively designated wrist without changing sides. Systolic and diastolic blood pressure values obtained from the smartwatch will be recorded separately.
Evening before surgery; Morning before surgery.
Heart Rate (HR) (Measured via Wrist)
Time Frame: Evening before surgery; Morning before surgery.
Heart rate (HR) will be measured at the wrist using a smartwatch. During measurement, a simultaneous reference reading will be obtained from the finger of the same arm using a finger pulse oximeter, with the time interval between devices kept to a minimum.
Evening before surgery; Morning before surgery.
Blood Oxygen Saturation (SpO2) (Measured via Wrist)
Time Frame: Evening before surgery; Morning before surgery.
Peripheral oxygen saturation (SpO₂) will be measured at the wrist using a smartwatch. During measurement, a simultaneous reference reading will be obtained from the finger of the same arm using a finger pulse oximeter, with the time interval between devices kept to a minimum.
Evening before surgery; Morning before surgery.
Anxiety Metric (Measured via Wrist)
Time Frame: Evening before surgery; Morning before surgery.
Anxiety level will be assessed using a smartwatch. The smartwatch categorizes anxiety into four levels: relaxed, low, moderate, and high. To minimize the potential influence of self-awareness of questionnaire results, the smartwatch-based assessment will be conducted after completion of the STAI.
Evening before surgery; Morning before surgery.
Sleep Quality (Measured via Wrist)
Time Frame: Single report obtained from continuous monitoring during the entire Night Before Surgery (from the evening when the watch is put on until the morning).
Sleep will be continuously monitored using a smartwatch throughout the preoperative night. At the end of the monitoring period, sleep quality will be quantified using a score ranging from 0 to 100, with higher scores reflecting better sleep quality.
Single report obtained from continuous monitoring during the entire Night Before Surgery (from the evening when the watch is put on until the morning).
Sleep Duration (Measured via Wrist)
Time Frame: Single report obtained from continuous monitoring during the entire Night Before Surgery (from the evening when the watch is put on until the morning).
Sleep duration will be continuously monitored using a smartwatch throughout the night. Total sleep duration will be reported in hours and minutes. In addition to total sleep duration, time spent in light sleep, REM sleep, wakefulness, and deep sleep will be reported as subcomponents. All sleep-related durations will be recorded separately in hours and minutes.
Single report obtained from continuous monitoring during the entire Night Before Surgery (from the evening when the watch is put on until the morning).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halil Kalaycı

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 96681246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

SPSS data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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