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Acupuncture as Pain Relief and Relaxation During Childbirth

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261755
Enrollment
607
Registered
2005-12-05
Start date
2001-03-31
Completion date
2004-05-31
Last updated
2008-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acupuncture Analgesia, Natural Childbirth

Keywords

Acupuncture, pain relief, labour, randomized controlled trial, TENS

Brief summary

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

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.

Interventions

PROCEDUREAcupuncture

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.

OTHERTENS

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.

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

Aarhus University Hospital Skejby
CollaboratorOTHER
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
CollaboratorOTHER
Direktør E. Danielsen og Hustrus Fond
CollaboratorUNKNOWN
Kong Christian den Tiendes Fond
CollaboratorUNKNOWN
Lundbeck Foundation
CollaboratorOTHER
Manufacturer Mads Clausen Foundation
CollaboratorOTHER
Else og Mogens Wedell-Wedellsborgs Fond
CollaboratorUNKNOWN
The Hede Nielsen Family Foundation
CollaboratorOTHER
Videns- og Forskningscenter for Alternativ Behandling
CollaboratorOTHER
DADJ (Den almindelige Danske Jordemoderforening)
CollaboratorUNKNOWN
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The need for conventional analgesic in each group.during labor

Secondary

MeasureTime frame
Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pHfrom 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026