The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01017861
First received: November 19, 2009
Last updated: September 27, 2010
Last verified: September 2010
  Purpose

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.


Condition
Pain
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Estimated Enrollment: 80
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant, 12th week
Pregnant women in the 12th week of pregnancy.
Pregnant, 28th week
Pregnant women in the 28th week of pregnancy.
Pregnant, full term
Pregnant women at full term, in hospital for an elective cesarean section.
Non pregnant women
Non pregnant women

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • informed consent
  • able to communicate in English
  • healthy pregnant patients in the 1st, 2nd and 3rd trimesters
  • healthy non-pregnant patients

Exclusion Criteria:

  • refusal to participate
  • Patients under age 18 or over age 40
  • Inability to communicate in English
  • Use of analgesics, anti-depressants and muscle relaxants
  • self-report of substance abuse
  • previous injury to the non-dominant arm/forearm
  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: NCT01017861

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose Carvalho, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01017861     History of Changes
Other Study ID Numbers: 09-04
Study First Received: November 19, 2009
Last Updated: September 27, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Temporal summation
Venipuncture pain

ClinicalTrials.gov processed this record on September 30, 2014