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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
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
September 5, 2017
Last Updated
September 12, 2017
Sponsor
Vrije Universiteit Brussel
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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
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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
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Pupil Dilation and Analgesia Nociception Index

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