Labor Pain Clinical Trial
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
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.
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 fill in a questionnaire regarding the satisfaction of pain relief using
TENS during labor. Augmentation of labor will be administered to achieve three uterine
contractions in 10 minutes in the first stage according to the protocol of induction of
labor. Continuous external electronic fetal heart rate monitoring and tocodynamometry are
used for fetal surveillance. Polygraph recording of maternal heart rate, transcutaneous
oxygen tension, respiratory rate will be used for evaluate the changes. Details of the
effect of analgesia in participants switching to it, the progression of cervical dilation
and the length of first stage after the application of TENS are recorded. The request for
epidural anesthesia or other form of analgesia will be available upon request. Adverse
events such as discomfort of movement restriction, skin allergy, or electrical accident were
recorded if any. Decision of performing operative delivery was made only according to
maternal and fetal indications. fMRI A scan will be collected in between 30-60 minutes after
the application TENS. Subjects will be asked to lie supine on the scanner bed and motion
artifact will be excluded. MR imaging parameters: Functional scans using 3.0-Tesla Siemens
Allegra MRI System equipped for echo-planar imaging. Blood oxygenation level-dependent
(BOLD) functional imaging will be carried out using a gradient echo T2-weighted pulse
sequence. At least 38 sagittal slices, 3 mm thick with 0.6-mm gap will be performed in each
scan. Image collection was preceded by four dummy scans to allow for equilibration of the
MRI signal. A3D MPRAGE T1-weighted high-resolution structure dataset was collected before
functional imaging to facilitate Talairach transformation and visualization.
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Observational Model: Case Control, Time Perspective: Prospective
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