Clinical Trial: fMRI Measurements on Pain Relief Methods in First Stage Labor Pain
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: fMRI Measurements on the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Acupuncture Points Verses Spontaneous Normal Vaginal Delivery to Relief of Labor Pain
Brief Summary: The purposes of this study is to integrate the objective tests into the subjective test, visual analog score (VAS), for evaluation and further understanding of relieving labor pain by TENS application on acupuncture points in the first stage of labor.
Detailed Summary:
Our published paper "Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor: a randomized double-blind placebo-controlled trial. (Pain 2007; 127:214-20 )" about the double-blind randomized placebo-controlled study, sponsored by NSC 91-2314-B-182A-162-grant in 2002, showed that TENS application on acupuncture points resulted in significantly better pain relief than placebo by visual analogue scale (VAS) score in the first stage of labor. Two hurdles that hampered physicians to evaluate the possible therapies in the management of obstetric pain. Firstly, there is no objective test for pain. Secondly, lack of controlled trials for different analgesic methods of pain treatment (interventional, psychological, physical therapy).
Transcutaneous electrical nerve stimulation (TENS) is one of the non-pharmacological means of pain relief for labor and delivery. We aimed to investigate the efficacy and safety of TENS on specific acupuncture points for reducing pain in the first stage of labor. In this double-blind, placebo-controlled trial, we randomly assigned healthy full-term parturients in active phase of first-stage labor to either TENS on 4 acupuncture points (Hegu [Li 4] and Sanyinjiao [Sp 6].
Visual analogue scale (VAS) will be used as an adjunct objective assessment of pain relief efficacy by having a scale with a range from 1 to 10, where 1 represented no pain and 10 the most painful. Participants will be asked by study personnel to estimate how painful during the last contractions before the application of TENS, 30 minutes and 60 minutes after TENS application. VAS will be recorded at each application (first, second application, and so forth) as described till the end of first stage. Within 24 hours after delivery, the women will be asked to
Sponsor: Chang Gung Memorial Hospital
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Chang Gung Memorial Hospital
Dates:
Date Received: October 5, 2008
Date Started: March 2008
Date Completion: December 2010
Last Updated: October 6, 2008
Last Verified: October 2008
