CClinicalTrials.gg
CompletedNCT01017861Updated Sep 28, 2010

The Effect of Pregnancy on Temporal Summation and Venipuncture Pain Perception

An observational study in Pain and Pregnancy, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-09-28.

Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain
  • Pregnancy

Keywords

  • Temporal summation
  • Venipuncture pain
03

In context

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)

Groups and 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

06

Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G1X5, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01017861
Lead sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
First posted
Nov 23, 2009
Start date
Oct 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Sep 28, 2010

Study contacts

Jose Carvalho, MD
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion