HRV and Pain Intensity

February 24, 2021 updated by: Moens Maarten

The Association Between Pain Intensity and Heart Rate Variability in Chronic Pain Patients.

The aim of this study is to explore the association between pain intensity and heart rate variability in patients with chronic pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Jette, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
          • Maarten Moens, prof. dr.
      • Roeselare, Belgium, 8800
        • Recruiting
        • AZ Delta
        • Contact:
          • Bart Billet, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic pain patients (regardless of the cause of the pain).

Description

Inclusion Criteria:

  • Patients with chronic pain for at least 3 months
  • Age > 18 years
  • Patient has been informed of the study procedures and has given written informed consent
  • Patient willing to comply with study protocol

Exclusion Criteria:

  • Healthy patients or patients with acute pain.
  • Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
  • Patients were excluded if they had one or more coexisting conditions known to affect HRV analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic pain
Patients with chronic pain, regardless of the cause of the pain.
Other: Heart Rate Variability
Heart Rate Variability will be measured with a Polar device.
Other: Pain intensity
Pain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: During study visit, cross-sectional, once, during 5 minutes.
Heart Rate Variability will be measured with a Polar device during a 5 minute recording.
During study visit, cross-sectional, once, during 5 minutes.
Pain Intensity with Numeric Rating Scale
Time Frame: During study visit, cross-sectional, once.
Pain Intensity will be measured with a Numeric Rating Scale.
During study visit, cross-sectional, once.
Pain Intensity with Visual Analogue Scale
Time Frame: During study visit, cross-sectional, once.
Pain Intensity will be measured with a Visual Analogue Scale.
During study visit, cross-sectional, once.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moens Maarten

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Anticipated)

October 15, 2021

Study Completion (Anticipated)

October 15, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 29, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INTERVAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Heart Rate Variability

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe