Changes in Heart Rate in Response to Heat Pressure and Neural Stimulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00678665
First received: May 13, 2008
Last updated: May 14, 2008
Last verified: May 2008
  Purpose

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 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: Initial Study for the Definition in Heart Rate Changes in Response to Heat Pressure and Neural Stimulation

Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 20
Study Start Date: May 2008
  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 20-40 years old subjects

Exclusion Criteria:

  • Heart deseases cardiovascular nedications hypertension neurological disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678665

Locations
Israel
Ben-Gurion University of the Negev Not yet recruiting
Beer-Sheva, Negev, Israel
Contact: Noami Amichai    972-8-624-4571      
Principal Investigator: Zvia Rudich, MD         
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 University Medical Center
ClinicalTrials.gov Identifier: NCT00678665     History of Changes
Other Study ID Numbers: SOR469908CTIL, SOR469908CTIL
Study First Received: May 13, 2008
Last Updated: May 14, 2008
Health Authority: Israel: Clalit Health Services

Keywords provided by Soroka University Medical Center:
ecg
TSA2000
Heart rate variability
wavelets

ClinicalTrials.gov processed this record on July 28, 2014