Acupuncture as Pain Relief and Relaxation During Childbirth

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

Detailed Description
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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.

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

Conditions
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Acupuncture Analgesia, Natural Childbirth

Intervention / Treatment
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* Procedure: Acupuncture
* Other: TENS
* Other: Traditional Group


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture Group<br>Acupuncture treatment during labor | Procedure: Acupuncture<br>* 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.<br>|
| Active Comparator: TENS Group<br>Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor | Other: TENS<br>* 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.<br>|
| Active Comparator: Traditional Group<br>Traditional pain treatment during labor | Other: Traditional Group<br>* 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.<br>* Other names: Tratitional analgesic;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, pain relief, labour, randomized controlled trial, TENS