Disc HerniationsNCT07322523
Smartwatch Accuracy for Measuring Vitals and Anxiety Before Disc Surgery
An observational study of Disc Herniations and Disc Herniation, Lumbar, run by Halil Kalaycı at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Disc Herniations, Disc Herniation, Lumbar, Cervical Disc Herniation
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 30 Mar 2026
- How long will I take part?
- 3 Months
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Kayseri
Halil Kalaycı, +903522076666 ext. 25551, halil.kalayci@erciyes.edu.tr
About this study
Official title: 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.
- Conditions
- Disc Herniations, Disc Herniation, Lumbar, Cervical Disc Herniation, Preoperative Anxiety Score, Sleep Quality, Preoperative Care
- Keywords
- Disc herniations, wearable devices, smart watch, vital signs monitoring, sleep quality, anxiety, surgical nursing,, preoperative
- Medical subject headings
- Intervertebral Disc Displacement, Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (BP) (Medical-Grade)
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.
Measured: Evening before surgery; Morning before surgery.
Heart Rate (HR) (Medical-Grade)
HR will be taken using a finger pulse oximeter on the finger of the same arm as the smartwatch at each time point.
Measured: Evening before surgery; Morning before surgery.
Blood Oxygen Saturation (SpO2) (Medical-Grade)
SpO2 will be taken using a finger pulse oximeter on the finger of the same arm as the smartwatch at each time point.
Measured: Evening before surgery; Morning before surgery.
State-Trait Anxiety Inventory (STAI) Score
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.
Measured: Evening before surgery; Morning before surgery.
Richards-Campbell Sleep Questionnaire (RCSQ) Score
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.
Measured: Evening before surgery; Morning before surgery
Blood Pressure (BP) (Measured via Wrist)
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.
Measured: Evening before surgery; Morning before surgery.
Heart Rate (HR) (Measured via Wrist)
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.
Measured: Evening before surgery; Morning before surgery.
Blood Oxygen Saturation (SpO2) (Measured via Wrist)
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.
Measured: Evening before surgery; Morning before surgery.
Anxiety Metric (Measured via Wrist)
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.
Measured: Evening before surgery; Morning before surgery.
Sleep Quality (Measured via Wrist)
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.
Measured: 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)
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.
Measured: Single report obtained from continuous monitoring during the entire Night Before Surgery (from the evening when the watch is put on until the morning).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Nov 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc HerniationsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Halil Kalaycı
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Sponsor-investigator, Halil Kalaycı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322523
- Sponsor's protocol ID
- 96681246
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: SPSS data
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Smartwatch Technology for Preoperative Monitoring of Sleep Quality, Anxiety, and Vital Signs in Patients Undergoing Disc Herniation Surgery
- ClinicalTrials.gov ID
- NCT07322523
- Acronym / sponsor ID
- 96681246
- Conditions
- Disc Herniations, Disc Herniation, Lumbar, Cervical Disc Herniation, Preoperative Anxiety Score, Sleep Quality, Preoperative Care
- Keywords
- Disc herniations, wearable devices, smart watch, vital signs monitoring, sleep quality, anxiety, surgical nursing,, preoperative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Halil KalaycıUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 7 Jan 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 7 Jan 2026.
- Individual participant dataSharing planned: Undecided. SPSS data
Related trials for Disc Herniations
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
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.
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 Disc Herniations and Disc Herniation, Lumbar, run by Halil Kalaycı 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Jan 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 Halil Kalaycı (+903522076666 ext. 28551, halil.kalayci@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (BP) (Medical-Grade) (time frame: Evening before surgery; Morning before surgery.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.