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Recruiting NCT07322523

Smartwatch Accuracy for Measuring Vitals and Anxiety Before Disc Surgery

Observational Disc Herniations Disc Herniation, Lumbar Cervical Disc Herniation Preoperative Anxiety Score

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Disc Herniations, Disc Herniation, Lumbar, Cervical Disc Herniation, Preoperative Anxiety Score. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Blood Pressure (BP) (Medical-Grade) [Time frame: Evening before surgery; Morning before surgery.]
  • Heart Rate (HR) (Medical-Grade) [Time frame: Evening before surgery; Morning before surgery.]
  • Blood Oxygen Saturation (SpO2) (Medical-Grade) [Time frame: Evening before surgery; Morning before surgery.]
  • State-Trait Anxiety Inventory (STAI) Score [Time frame: Evening before surgery; Morning before surgery.]
  • Richards-Campbell Sleep Questionnaire (RCSQ) Score [Time frame: Evening before surgery; Morning before surgery]
  • Blood Pressure (BP) (Measured via Wrist) [Time frame: Evening before surgery; Morning before surgery.]
  • Heart Rate (HR) (Measured via Wrist) [Time frame: Evening before surgery; Morning before surgery.]
  • Blood Oxygen Saturation (SpO2) (Measured via Wrist) [Time frame: Evening before surgery; Morning before surgery.]
  • Anxiety Metric (Measured via Wrist) [Time frame: 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Erciyes University — Kayseri

Identifiers

NCT: NCT07322523 · 96681246

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗