We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678665
First Posted: May 15, 2008
Last Update Posted: May 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zvia Rudich MD, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00678665     History of Changes
Other Study ID Numbers: SOR469908CTIL
First Submitted: May 13, 2008
First Posted: May 15, 2008
Last Update Posted: May 15, 2008
Last Verified: May 2008

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