Changes in Heart Rate in Response to Cold Pressor Test (HRVW1)

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00678262
First received: May 13, 2008
Last updated: September 19, 2010
Last verified: September 2010
  Purpose

Abstract:

Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an important factor in patients' recovery and quality of life. Pain is charted today as one of the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score (facial or numerical), by which the patient himself indicates the level of the pain he or she endures. It has been found that the correlation between the reported pain by the patient and the assessed pain by the caregivers or the medical personnel becomes poor as pain intensifies.

Objective assessment of anesthesia using the heart rate and its spectral analyses was done in the past. By using this modality, works on neonatal pain were conducted. In adults, works have shown that there is possibility to assess pain using this modality, though no repeated proof for its ability to detect pain was published.

We know that physiological signals such as ECG consist of mixtures of variety of patterns and phenomena accruing at different patterns and time points. Traditional analysis methods are designed and optimized to handle signals that include a single class of patterns such as pure harmonics or piece-wise constant functions. However, such basic operations that use a single representation method usually yield mediocre results when applied to real complex biological signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very low. Recent trends in digital signal processing (DSP) use the novel idea of merging several different representation methods to create a so called over-complete dictionary, examples of this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We intend to develop and apply the novel signal processing tools to the ECG signals during painful experience for the first time. We believe that such tools have the potential to provide much better insight of the signal basic components and their relation to pain.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Changes in Heart Rate in Response to Cold Pressor Test

Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 20
Study Start Date: May 2008
Estimated Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteers

Criteria

Inclusion Criteria:

  • healthy volunteers age 20-40

Exclusion Criteria:

  • Heart diseases Hypertension Cardiovascular medication Neurological diseases
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00678262

Locations
Israel
Soroka University Medical Center
Beer-Sheva, Negev, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Zvia Rudich, MD Soroka UMC
  More Information

No publications provided

Responsible Party: Zvia Rudich MD, Soroka Medical Center Beer-Sheva, Israel
ClinicalTrials.gov Identifier: NCT00678262     History of Changes
Other Study ID Numbers: SOR470008CTIL
Study First Received: May 13, 2008
Last Updated: September 19, 2010
Health Authority: Israel: Clalit Health Services

Keywords provided by Soroka University Medical Center:
pain
ECG
Heart rate variability
wavelets

ClinicalTrials.gov processed this record on July 23, 2014