Acupuncture as Pain Relief and Relaxation During Childbirth
NCT ID: NCT00261755
Last Updated: 2008-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
607 participants
INTERVENTIONAL
2001-03-31
2004-05-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acupuncture Group
Acupuncture treatment during labor
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
Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
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
Traditional pain treatment during labor
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.
Interventions
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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
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Aarhus University Hospital Skejby
OTHER
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
OTHER
Direktør E. Danielsen og Hustrus Fond
UNKNOWN
Kong Christian den Tiendes Fond
UNKNOWN
Lundbeck Foundation
OTHER
Manufacturer Mads Clausen Foundation
OTHER
Else og Mogens Wedell-Wedellsborgs Fond
UNKNOWN
The Hede Nielsen Family Foundation
OTHER
Videns- og Forskningscenter for Alternativ Behandling
OTHER
DADJ (Den almindelige Danske Jordemoderforening)
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
Principal Investigators
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Lone Hvidman, MD,PhD
Role: STUDY_CHAIR
Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
Morten Hedegaard, MD, PhD
Role: STUDY_CHAIR
Department Obstetrics, Rigshospitalet, Denmark
Lissa Borup, Midwife
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics, Aarhus University Hospital, Skejby
Winnie M. Wurlitzer, Midwife
Role: PRINCIPAL_INVESTIGATOR
Department of obstetrics, Aarhus University Hospital, Skejby
Locations
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Dept Obstetrics, Aarhus University Hospital, Skejby
Aarhus, , Denmark
Countries
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Other Identifiers
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Akupunktur2001-41-1305
Identifier Type: -
Identifier Source: org_study_id