NCT00678262

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

May 13, 2008

Last Update Submit

September 19, 2010

Conditions

Keywords

painECGHeart rate variabilitywavelets

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers

You may qualify if:

  • healthy volunteers age 20-40

You may not qualify if:

  • Heart diseases Hypertension Cardiovascular medication Neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Negev, Israel

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zvia Rudich, MD

    Soroka UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations