Acupuncture as Pain Relief and Relaxation During Childbirth

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT00261755

Collaborator

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

607

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acupuncture Analgesia Natural Childbirth	Procedure: Acupuncture Other: TENS Other: Traditional Group	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

607 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2001

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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.
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.
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 Names: Tratitional analgesic

Arm

Intervention/Treatment

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.

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.

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 Names:

Tratitional analgesic

Outcome Measures

Primary Outcome Measures

The need for conventional analgesic in each group. [during labor]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept Obstetrics, Aarhus University Hospital, Skejby	Aarhus		Denmark	8200

Sponsors and Collaborators

University of Aarhus
Aarhus University Hospital Skejby
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Direktør E. Danielsen og Hustrus Fond
Kong Christian den Tiendes Fond
Lundbeck Foundation
Manufacturer Mads Clausen Foundation
Else og Mogens Wedell-Wedellsborgs Fond
Hede Nielsen
Videns- og Forskningscenter for Alternativ Behandling
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