Pain MeasurementNCT05129007
Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring
An observational study of Pain Measurement, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Oura ring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients from Finland
Who may be able to join
- Upcoming herniated disc surgery, ability to give a written informed concent
Who cannot join
- Sleep apnea, Condition with irregular heart rate, lack of cooperation
Trial locations and contacts
1 site in 1 country.
Jarkko Harju, md, phd contact
Finland1 site, 1 recruiting
- Recruiting
Tampere university hospital
Tampere, Pirkanmaa, 33521
Tommi Bergman, Md, 0331166356, tommi.bergman@pshp.fi
About this study
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.
Read the 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.
- Conditions
- Pain Measurement
- Being tested
- Oura ring
- Keywords
- Pain, Oura ring, Activity measurment, Herniated disc
- Medical subject headings
- Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oura ringDevice
Also called Pain questionnaire, BDI-questionnaire
Photopletysmography based noninvasive device
| Study group | Role | What they receive |
|---|---|---|
| Study group | All patients Receives: Device: Oura ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability
collected from Oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in resting mean heart rate
collected from Oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in ventilatory rate
collected from oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in sleep onset latency
collected from oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in sleep efficiency
percentage of the time spent asleep while in bed collected from oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in number of nighttime awakenings
collected from oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in total sleep time
collected from oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in sleep stages (awake, light sleep, deep sleep and rem sleep)
percentages of each sleep stages collected from oura ring
Measured: comparison of mean value prior to surgery and one month after surgery
Change in symptoms based on symptom diary
Daily symptom diary kept by patient
Measured: prior surgery and one month after surgery
Secondary outcomes (2)
Change in BDI questionnaire points
BECK Depression Inventory (Scale 1-63, higher scores mean a worse outcome)
Measured: one month prior surgery and one month after surgery
Change in pain questionnaire
Descriptive questionnaire
Measured: one month prior surgery and one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Nov 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oura health oy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129007
- Sponsor's protocol ID
- R21071L
- Status last verified
- Apr 2023
- First submitted
- 17 Sep 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring
- ClinicalTrials.gov ID
- NCT05129007
- Acronym / sponsor ID
- R21071L
- Conditions
- Pain Measurement
- Keywords
- Pain, Oura ring, Activity measurment, Herniated disc
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Oura health oy
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Oura ringAll patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients from Finland
Key inclusion criteria (1 listed)
- Upcoming herniated disc surgery, ability to give a written informed concent
Key exclusion criteria (1 listed)
- Sleep apnea, Condition with irregular heart rate, lack of cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oura ringAlso: Pain questionnaire, BDI-questionnairePhotopletysmography based noninvasive device | Device | Study group |
Primary outcome
Change in heart rate variability
Time frame: comparison of mean value prior to surgery and one month after surgery
collected from Oura ring
Change in resting mean heart rate
Time frame: comparison of mean value prior to surgery and one month after surgery
collected from Oura ring
Change in ventilatory rate
Time frame: comparison of mean value prior to surgery and one month after surgery
collected from oura ring
Change in sleep onset latency
Time frame: comparison of mean value prior to surgery and one month after surgery
collected from oura ring
Change in sleep efficiency
Time frame: 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
Time frame: comparison of mean value prior to surgery and one month after surgery
collected from oura ring
Change in total sleep time
Time frame: 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)
Time frame: 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
Time frame: prior surgery and one month after surgery
Daily symptom diary kept by patient
2 secondary outcomes
Change in BDI questionnaire points
Time frame: one month prior surgery and one month after surgery
Change in pain questionnaire
Time frame: one month prior surgery and one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Pain Measurement
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Recruiting
Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
Postoperative Pain, Adenotonsillectomy
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Not yet recruitingObservational study
Pain Prediction Via Machine Learning: Electrical Thresholds and Interoception
University Students
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarkko Harju, md, phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Measurement, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tommi Bergman, Md (0331166356, tommi.bergman@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate variability (time frame: comparison of mean value prior to surgery and one month after surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.