Acupuncture as Pain Relief and Relaxation During Childbirth
This study has been completed.
Sponsor:
University of Aarhus
Collaborators:
Skejby Hospital
Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeck Foundation
Fabrikant Mads Clausens Fond
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns og forskningscenter for alternativ behandling (VIFAB )
DADJ (Den almindelige Danske Jordemoderforening)
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00261755
First received: December 2, 2005
Last updated: May 6, 2008
Last verified: May 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.
| Condition | Intervention | Phase |
|---|---|---|
|
Acupuncture Analgesia Natural Childbirth |
Procedure: Acupuncture Other: TENS Other: Traditional Group |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study |
Resource links provided by NLM:
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- The need for conventional analgesic in each group. [ Time Frame: during labor ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH [ Time Frame: from randomization until birth ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Questionaries filled out by the parturients to investigate satisfactory with analgesic given. [ Time Frame: two months after delivery ] [ Designated as safety issue: Yes ]
| Enrollment: | 607 |
| Study Start Date: | March 2001 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acupuncture Group
Acupuncture treatment during labor
|
Procedure: 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.
Other Name: Acupuncture
|
|
Active Comparator: TENS Group
Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor
|
Other: 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.
Other Name: TENS
|
|
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
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261755
Locations
| Denmark | |
| Dept Obstetrics, Aarhus University Hospital, Skejby | |
| Aarhus, Denmark, 8200 | |
Sponsors and Collaborators
University of Aarhus
Skejby Hospital
Snedkermester Sophus Jacobsen og Hustru Astrid Jacobsens Fond
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeck Foundation
Fabrikant Mads Clausens Fond
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns og forskningscenter for alternativ behandling (VIFAB )
DADJ (Den almindelige Danske Jordemoderforening)
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Lone Hvidman, MD,PhD, Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark |
| ClinicalTrials.gov Identifier: | NCT00261755 History of Changes |
| Other Study ID Numbers: | Akupunktur2001-41-1305 |
| Study First Received: | December 2, 2005 |
| Last Updated: | May 6, 2008 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by University of Aarhus:
|
Acupuncture pain relief labour randomized controlled trial TENS |
Additional relevant MeSH terms:
|
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013