Acupuncture as Pain Relief and Relaxation During Childbirth
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|ClinicalTrials.gov Identifier: NCT00261755|
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : May 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Acupuncture Analgesia Natural Childbirth||Procedure: Acupuncture Other: TENS Other: Traditional Group||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||607 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||May 2004|
Experimental: Acupuncture Group
Acupuncture treatment during labor
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
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 Name: Tratitional analgesic
- The need for conventional analgesic in each group. [ Time Frame: during labor ]
- Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH [ Time Frame: from randomization until birth ]
- 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 ]
- Questionaries filled out by the parturients to investigate satisfactory with analgesic given. [ Time Frame: two months after delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261755
|Dept Obstetrics, Aarhus University Hospital, Skejby|
|Aarhus, Denmark, 8200|
|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|