Clinical Trials Directory

Trials / Completed

CompletedNCT00261755

Acupuncture as Pain Relief and Relaxation During Childbirth

Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
607 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

Summary

The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.

Detailed description

The purpose of this study is to investigate the effect of acupuncture for pain relief an relaxation during childbirth. In a controlled study 607 healthy patients in active labor at term are randomly assigned to receive either acupuncture, TENS or traditional analgesia. Pharmacological analgesia is provided on request. The treatment is administered by midwives trained in acupuncture and TENS. The objective parameter of outcome is the need for conventional analgesia in each group. Visual analogue scale assessments are used to evaluate participants perception of pain before, during and after treatment. Questionnaires filled out two months after delivery is used to investigate the patients experience and satisfaction with delivery and analgesia.

Conditions

Interventions

TypeNameDescription
PROCEDUREAcupunctureBased on international experiences and experiences from the pilot project 34 specified acupuncture points could be used.Treatment was individualised according to the woman's mobility and localization of pain. Needles were sterile stainless steel acupuncture needles in three lengths: 0.20 x 15 mm, 0.30 x 30 mm and 0.35 x 50 mm. No electric stimulation was used. The duration of needling could vary from 30 minutes to two hours and could be repeated. The needles were removed if the patient felt uncomfortable or in cases with obstetric pathology.
OTHERTENSThe Transcutaneous Electric Nerve Stimulation (TENS treatment) was carried out using a B.C - TENS 120Z unit. Two to four electrodes were placed on the skin of the lower back. The units were set in constant mode, initially with a pulse width of 60 micro-seconds and a pulse rate of 100 pulses per second. The treatment lasted from 20 to 45 minutes and could be repeated. The intensity of stimulation could be adjusted by the woman or the midwife.
OTHERTraditional GroupAll analgesic methods available (Sterile water papules, nitro oxygen, bath tub, pethidine and epidural analgesics (EDA)). A specific analgesic was chosen by the woman and the midwife after informed choice.

Timeline

Start date
2001-03-01
Primary completion
2004-02-01
Completion
2004-05-01
First posted
2005-12-05
Last updated
2008-05-07

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT00261755. Inclusion in this directory is not an endorsement.