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| Name | Class |
|---|---|
| Aarhus University Hospital Skejby | OTHER |
| Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation | OTHER |
| Direktør E. Danielsen og Hustrus Fond | UNKNOWN |
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The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Group | Experimental | Acupuncture treatment during labor |
|
| TENS Group | Active Comparator | Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor |
|
| Traditional Group | Active Comparator | Traditional pain treatment during labor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The need for conventional analgesic in each group. | during labor |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lone Hvidman, MD,PhD | Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark | Study Chair |
| Morten Hedegaard, MD, PhD | Department Obstetrics, Rigshospitalet, Denmark | Study Chair |
| Lissa Borup, Midwife | Department of Obstetrics, Aarhus University Hospital, Skejby | Principal Investigator |
| Winnie M. Wurlitzer, Midwife | Department of obstetrics, Aarhus University Hospital, Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Obstetrics, Aarhus University Hospital, Skejby | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
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| 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 |
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| TENS | Other | 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 | Other | 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. |
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| Questionaries filled out by the parturients to investigate satisfactory with analgesic given. | two months after delivery |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |