Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring

NCT ID: NCT05129007

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Pain Measurement

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

All patients

Oura ring

Intervention Type DEVICE

Photopletysmography based noninvasive device

Interventions

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Oura ring

Photopletysmography based noninvasive device

Intervention Type DEVICE

Other Intervention Names

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Pain questionnaire, BDI-questionnaire

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oura health oy

UNKNOWN

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tampere university hospital

Tampere, Pirkanmaa, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Tommi Bergman, Md

Role: CONTACT

0331166356

Jarkko Harju, md, phd

Role: CONTACT

Facility Contacts

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Tommi Bergman, Md

Role: primary

0331166356

Other Identifiers

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R21071L

Identifier Type: -

Identifier Source: org_study_id

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