Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring

Recruiting

• Conditions: Pain Measurement
• Interventions: Device: Oura ring

• Registration Number: NCT05129007
• Lead Sponsor: Tampere University Hospital

Brief Summary

The objective of this research study is to show whether data given by Oura ring could be used to objectively measure patients pain and well-being before and after disc surgery.

Detailed Description

The study will consist of a total 30 disc prolapse patients. Patients are given Oura rings along with other treatment. Patients use Oura rings before and after disc surgery. Patients will also fill Beck Depression Inventory (BDI) and pain detect inquiries in the beginning and in the end of study. Patients symptoms will also be followed daily by electrical symptom diary.

Oura rings technology is based on photoplethysmography( PPG). PPG is a noninvasive method to detect blood volume changes in the microvascular bed of tissue. PPG waveform varies by respiration, sympathetic nervous system activity and thermoregulation. Oura ring gives information of patients activity level, calorie consumption, steps count, resting heart rate,heart rate variability, respiration rate, body temperature, sleep depth and quality of sleep.

Data collected with Oura ring after disc surgery will be compared to data collected before surgery.

Study Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-11-22
• Study Start: 2022-11-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Upcoming herniated disc surgery, ability to give a written informed concent

Exclusion Criteria

• Sleep apnea, Condition with irregular heart rate, lack of cooperation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Oura ring	All patients

Primary Outcome Measures

Name	Time	Method
Change in heart rate variability	comparison of mean value prior to surgery and one month after surgery	collected from Oura ring
Change in resting mean heart rate	comparison of mean value prior to surgery and one month after surgery	collected from Oura ring
Change in ventilatory rate	comparison of mean value prior to surgery and one month after surgery	collected from oura ring
Change in sleep onset latency	comparison of mean value prior to surgery and one month after surgery	collected from oura ring
Change in sleep efficiency	comparison of mean value prior to surgery and one month after surgery	percentage of the time spent asleep while in bed collected from oura ring
Change in number of nighttime awakenings	comparison of mean value prior to surgery and one month after surgery	collected from oura ring
Change in total sleep time	comparison of mean value prior to surgery and one month after surgery	collected from oura ring
Change in sleep stages (awake, light sleep, deep sleep and rem sleep)	comparison of mean value prior to surgery and one month after surgery	percentages of each sleep stages collected from oura ring
Change in symptoms based on symptom diary	prior surgery and one month after surgery	Daily symptom diary kept by patient

Secondary Outcome Measures

Name	Time	Method
Change in BDI questionnaire points	one month prior surgery and one month after surgery	BECK Depression Inventory (Scale 1-63, higher scores mean a worse outcome)
Change in pain questionnaire	one month prior surgery and one month after surgery	Descriptive questionnaire

Trial Locations

Locations (1)

Tampere university hospital; 🇫🇮 Tampere, Pirkanmaa, Finland