Skip to main content
Clinical Trials/NCT03280238
NCT03280238
Completed
Not Applicable

Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers

Vrije Universiteit Brussel1 site in 1 country19 target enrollmentMarch 1, 2017
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Vrije Universiteit Brussel
Enrollment
19
Locations
1
Primary Endpoint
Pupil dilation in relation to pain
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
May 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wendy Van Bogaert

Medical Student

Vrije Universiteit Brussel

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

Outcomes

Primary Outcomes

Pupil dilation in relation to pain

Time Frame: 2sec before until 4sec after each painful stimulus

measurement of pupil dilation

Secondary Outcomes

  • Analgesia nociception index in relation to pain(30sec before until 60sec after each painful stimulus)

Study Sites (1)

Loading locations...

Similar Trials