Acupuncture as Pain Relief and Relaxation During Childbirth

This study has been completed.
Sponsor:
Collaborators:
Skejby Hospital
Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeck Foundation
Fabrikant Mads Clausens Fond
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns og forskningscenter for alternativ behandling (VIFAB )
DADJ (Den almindelige Danske Jordemoderforening)
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00261755
First received: December 2, 2005
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Acupuncture Analgesia
Natural Childbirth
Procedure: Acupuncture
Other: TENS
Other: Traditional Group
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The need for conventional analgesic in each group. [ Time Frame: during labor ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH [ Time Frame: from randomization until birth ] [ Designated as safety issue: Yes ]
  • visual analogue scale is used to evaluate subjective effect on pain. [ Time Frame: Just before randomization, one hour after randomization and subsequently every two hours until the child was born ] [ Designated as safety issue: Yes ]
  • Questionaries filled out by the parturients to investigate satisfactory with analgesic given. [ Time Frame: two months after delivery ] [ Designated as safety issue: Yes ]

Enrollment: 607
Study Start Date: March 2001
Study Completion Date: May 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture Group
Acupuncture treatment during labor
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 Name: Acupuncture
Active Comparator: TENS Group
Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
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 Name: TENS
Active Comparator: Traditional Group
Traditional pain treatment during labor
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.
Other Name: Tratitional analgesic

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, Danish speaking women with a normal singleton pregnancy giving birth at term 37 - 42 weeks) with a fetus in cephalic presentation.

Exclusion Criteria:

  • Women with medical diseases or complicated pregnancy. Women who has already received conventional analgesia during labor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261755

Locations
Denmark
Dept Obstetrics, Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Skejby Hospital
Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeck Foundation
Fabrikant Mads Clausens Fond
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns og forskningscenter for alternativ behandling (VIFAB )
DADJ (Den almindelige Danske Jordemoderforening)
Investigators
Study Chair: Lone Hvidman, MD,PhD Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
Study Chair: Morten Hedegaard, MD, PhD Department Obstetrics, Rigshospitalet, Denmark
Principal Investigator: Lissa Borup, Midwife Department of Obstetrics, Aarhus University Hospital, Skejby
Principal Investigator: Winnie M. Wurlitzer, Midwife Department of obstetrics, Aarhus University Hospital, Skejby
  More Information

No publications provided

Responsible Party: Lone Hvidman, MD,PhD, Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
ClinicalTrials.gov Identifier: NCT00261755     History of Changes
Other Study ID Numbers: Akupunktur2001-41-1305
Study First Received: December 2, 2005
Last Updated: May 6, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Acupuncture
pain relief
labour
randomized controlled trial
TENS

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014