Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring

Sponsor
Tampere University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05129007
Collaborator
Oura health oy (Other)
30
1
25
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Oura ring

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Study group

All patients

Device: Oura ring
Photopletysmography based noninvasive device
Other Names:
  • Pain questionnaire, BDI-questionnaire
  • Outcome Measures

    Primary Outcome Measures

    1. Change in heart rate variability [comparison of mean value prior to surgery and one month after surgery]

      collected from Oura ring

    2. Change in resting mean heart rate [comparison of mean value prior to surgery and one month after surgery]

      collected from Oura ring

    3. Change in ventilatory rate [comparison of mean value prior to surgery and one month after surgery]

      collected from oura ring

    4. Change in sleep onset latency [comparison of mean value prior to surgery and one month after surgery]

      collected from oura ring

    5. 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

    6. Change in number of nighttime awakenings [comparison of mean value prior to surgery and one month after surgery]

      collected from oura ring

    7. Change in total sleep time [comparison of mean value prior to surgery and one month after surgery]

      collected from oura ring

    8. 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

    9. Change in symptoms based on symptom diary [prior surgery and one month after surgery]

      Daily symptom diary kept by patient

    Secondary Outcome Measures

    1. 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)

    2. Change in pain questionnaire [one month prior surgery and one month after surgery]

      Descriptive questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tampere university hospital Tampere Pirkanmaa Finland 33521

    Sponsors and Collaborators

    • Tampere University Hospital
    • Oura health oy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tampere University Hospital
    ClinicalTrials.gov Identifier:
    NCT05129007
    Other Study ID Numbers:
    • R21071L
    First Posted:
    Nov 22, 2021
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tampere University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 22, 2021