Pupil Dilation and Analgesia Nociception Index
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Measurement of pupil dilation and analgesia nociception index
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain
Eligibility Criteria
Inclusion Criteria:
- good health
- no acute or chronic pain conditions
- well rested
Exclusion Criteria:
- chronic treatment
- bad health
- daily use of analgetics or other medication
- weekly tobacco use
- weekly use of recreational drugs
- more than 10 alcohol consumptions a week
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experiment
Arm Description
Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France) Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)
Outcomes
Primary Outcome Measures
Pupil dilation in relation to pain
measurement of pupil dilation
Secondary Outcome Measures
Analgesia nociception index in relation to pain
measurement of analgesia nociception index
Full Information
NCT ID
NCT03280238
First Posted
September 5, 2017
Last Updated
September 12, 2017
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT03280238
Brief Title
Pupil Dilation and Analgesia Nociception Index
Official Title
Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experiment
Arm Type
Experimental
Arm Description
Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode
Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France)
Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)
Intervention Type
Diagnostic Test
Intervention Name(s)
Measurement of pupil dilation and analgesia nociception index
Intervention Description
painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured
Primary Outcome Measure Information:
Title
Pupil dilation in relation to pain
Description
measurement of pupil dilation
Time Frame
2sec before until 4sec after each painful stimulus
Secondary Outcome Measure Information:
Title
Analgesia nociception index in relation to pain
Description
measurement of analgesia nociception index
Time Frame
30sec before until 60sec after each painful stimulus
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
good health
no acute or chronic pain conditions
well rested
Exclusion Criteria:
chronic treatment
bad health
daily use of analgetics or other medication
weekly tobacco use
weekly use of recreational drugs
more than 10 alcohol consumptions a week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Van Bogaert, MS
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reginald Deschepper, PhD
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
8737210
Citation
Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
Results Reference
background
PubMed Identifier
10098379
Citation
Chapman CR, Oka S, Bradshaw DH, Jacobson RC, Donaldson GW. Phasic pupil dilation response to noxious stimulation in normal volunteers: relationship to brain evoked potentials and pain report. Psychophysiology. 1999 Jan;36(1):44-52. doi: 10.1017/s0048577299970373.
Results Reference
background
PubMed Identifier
23922336
Citation
Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6.
Results Reference
background
Learn more about this trial
Pupil Dilation and Analgesia Nociception Index
We'll reach out to this number within 24 hrs