Smartwatch Accuracy for Measuring Vitals and Anxiety Before Disc Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorHalil Kalaycı

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Preoperative Disc Herniation Patients

Trial outcomes

Primary outcomes

1

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.

Time frame
Evening before surgery; Morning before surgery.
2

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.

Time frame
Evening before surgery; Morning before surgery.
3

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.

Time frame
Evening before surgery; Morning before surgery.
4

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.

Time frame
Evening before surgery; Morning before surgery.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Halil Kalaycı

Lead sponsor

TC Erciyes University

Sponsor institution

TC Erciyes University

Collaborator