Acupuncture as Pain Relief and Relaxation During Childbirth - Full Text View

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 I Phase II

MedlinePlus related topics:

Acupuncture

ChemIDplus related topics:

Meperidine Meperidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

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
Acupuncture Group: Experimental 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.
TENS Group: Active Comparator 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.
Traditional Group: Active Comparator 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.

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

Lundbeckfonden

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

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

Keywords provided by University of Aarhus:

Acupuncture

pain relief

labour

randomized controlled trial

TENS

Study placed in the following topic categories:

Pain

Meperidine

ClinicalTrials.gov processed this record on August 29, 2008

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 Lundbeckfonden 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