The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception
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| First Received Date ICMJE | November 19, 2009 | ||||
| Last Updated Date | September 27, 2010 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01017861 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception | ||||
| Official Title ICMJE | The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception | ||||
| Brief Summary | Recent studies have shown that women are more likely to experience pain in many medical situations. During pregnancy, women may experience an increase in pain threshold. This is thought to be related to hormonal changes and an increase in the level of certain natural pain-relieving substances in their bodies. It is important to develop simple tests to identify woman at higher risk for pain so the investigators can help them. Temporal summation is what happens when a person becomes more sensitive to a certain feeling on their skin when it is applied several times over the course of several seconds. The investigators hypothesize that pregnant women show decreased temporal summation and pain scores to venipuncture, compared to non-pregnant women. |
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| Detailed Description | Recent epidemiologic studies have shown that women are at substantially greater risk for many clinical pain conditions, and there is a suggestion that postoperative and procedural pain may be more severe among women then men. During pregnancy, women experience an elevation in the threshold to pain and discomfort. In addition to hormonal changes, the changes in pain perception during pregnancy may be related to an increase in endogenous opioids. Pain is the most feared experience in the intra and postpartum period, and severe pain experienced during this time can lead to significant morbidity, including chronic pain and depression. Much attention has been paid to tests that can predict patients at higher risk for pain. Temporal summation (TS) has been shown to be a simple and reliable test. Temporal summation represents the physiological wind-up phenomenon taking place at the spinal level of the central pain pathways. TS extent can be measured in humans by administering a series of noxious stimuli of constant intensity and of various modalities in order to evoke an increase in perceived pain. It is a very simple and easy test to perform, and very well tolerated by patients. Whether TS changes in pregnancy and whether TS in pregnancy correlates with pain perception during acute stimuli such as venipuncture is unknown. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Pregnant patients presenting at the venipuncture clinic for routine bloodwork throughout their pregnancy. Full term pregnant patients admitted to the hospital for and elective cesarean section. Non pregnant volunteers. |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01017861 | ||||
| Other Study ID Numbers ICMJE | 09-04 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Jose Carvalho, Mount Sinai Hospital | ||||
| Study Sponsor ICMJE | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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