Acupuncture as Pain Relief and Relaxation During Childbirth

NCT00261755 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2008-05-07

No results posted yet for this study

Summary

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

Conditions

  • Acupuncture Analgesia
  • Natural Childbirth

Interventions

PROCEDURE

Acupuncture

Based 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.

OTHER

TENS

The 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.

OTHER

Traditional Group

All 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.

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    collaborator OTHER
  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

    collaborator OTHER
  • Direktør E. Danielsen og Hustrus Fond

    collaborator UNKNOWN
  • Kong Christian den Tiendes Fond

    collaborator UNKNOWN
  • Lundbeck Foundation

    collaborator OTHER
  • Manufacturer Mads Clausen Foundation

    collaborator OTHER
  • Else og Mogens Wedell-Wedellsborgs Fond

    collaborator UNKNOWN
  • The Hede Nielsen Family Foundation

    collaborator OTHER
  • Videns- og Forskningscenter for Alternativ Behandling

    collaborator OTHER
  • DADJ (Den almindelige Danske Jordemoderforening)

    collaborator UNKNOWN
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Lone Hvidman, MD,PhD · Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark

  • Morten Hedegaard, MD, PhD · Department Obstetrics, Rigshospitalet, Denmark

  • Lissa Borup, Midwife · Department of Obstetrics, Aarhus University Hospital, Skejby

  • Winnie M. Wurlitzer, Midwife · Department of obstetrics, Aarhus University Hospital, Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2004-02-29
Completion
2004-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00261755 on ClinicalTrials.gov