Acupuncture as Pain Relief and Relaxation During Childbirth

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

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

Study Overview

• Status: Completed
• Conditions: Natural Childbirth; Acupuncture Analgesia
• Intervention / Treatment: Procedure: Acupuncture; Other: TENS; Other: Traditional Group

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.

• Study Type: Interventional
• Enrollment (Actual): 607
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Dept Obstetrics, Aarhus University Hospital, Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.
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 Names: Tratitional analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The need for conventional analgesic in each group.	during labor

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital Skejby; Lundbeck Foundation; Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation; Videns- og Forskningscenter for Alternativ Behandling; Kong Christian den Tiendes Fond; Direktør E. Danielsen og Hustrus Fond; Manufacturer Mads Clausen Foundation; Else og Mogens Wedell-Wedellsborgs Fond; Hede Nielsen; 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

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Primary Completion (Actual): February 1, 2004
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: December 2, 2005
• First Submitted That Met QC Criteria: December 2, 2005
• First Posted (Estimate): December 5, 2005

Study Record Updates

• Last Update Posted (Estimate): May 7, 2008
• Last Update Submitted That Met QC Criteria: May 6, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: TENS; randomized controlled trial; Acupuncture; pain relief; labour
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: Akupunktur2001-41-1305