HRV and Pain Intensity

• Conditions: Chronic Pain
• Interventions: Other: Heart Rate Variability; Other: Pain intensity

• Registration Number: NCT04539353
• Lead Sponsor: Moens Maarten

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-29
• Study First Posted: 2020-09-07
• Study Start: 2020-12-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic pain	Pain intensity	Patients with chronic pain, regardless of the cause of the pain.
chronic pain	Heart Rate Variability	Patients with chronic pain, regardless of the cause of the pain.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium