Clinical trial NCT05129007: Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring
Official title: Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Measurement
Keywords: Pain
Oura ring
Activity measurment
Herniated disc
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Oura health oy
First posted: 2021-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients from Finland

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in heart rate variability
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in resting mean heart rate
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in ventilatory rate
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in sleep onset latency
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in sleep efficiency
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in number of nighttime awakenings
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in total sleep time
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in sleep stages (awake, light sleep, deep sleep and rem sleep)
timeFrame: comparison of mean value prior to surgery and one month after surgery
measure: Change in symptoms based on symptom diary
timeFrame: prior surgery and one month after surgery
Secondary outcomes:
measure: Change in BDI questionnaire points
timeFrame: one month prior surgery and one month after surgery
measure: Change in pain questionnaire
timeFrame: one month prior surgery and one month after surgery
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere university hospital
state: Pirkanmaa
Study officials:
References: