HRV and Pain Intensity

• Sponsor: Moens Maarten (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04539353
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 10
• Patients Per Site: 100
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Other: Heart Rate Variability; Other: Pain intensity

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: The Association Between Pain Intensity and Heart Rate Variability in Chronic Pain Patients.
• Actual Study Start Date: Dec 14, 2020
• Anticipated Primary Completion Date: Oct 15, 2021
• Anticipated Study Completion Date: Oct 15, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. Pain Intensity with Numeric Rating Scale [During study visit, cross-sectional, once.]

   Pain Intensity will be measured with a Numeric Rating Scale.

3. Pain Intensity with Visual Analogue Scale [During study visit, cross-sectional, once.]

   Pain Intensity will be measured with a Visual Analogue Scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Jette		Belgium	1090
2	AZ Delta	Roeselare		Belgium	8800

Sponsors and Collaborators

• Moens Maarten

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moens Maarten, principal investigator, Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT04539353
• Other Study ID Numbers: INTERVAL
• First Posted: Sep 7, 2020
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain; Pain

Study Results

No Results Posted as of Feb 25, 2021