Acupuncture as Pain Relief and Relaxation During Childbirth

NCT00261755 | Completed Phase 1

• 1 other identifier: Akupunktur2001-41-1305
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acupuncture Analgesia; Natural Childbirth

Keywords

Acupuncture; pain relief; labour; randomized controlled trial; TENS

Outcome Measures

Primary Outcomes (1)

• The need for conventional analgesic in each group.

  during labor

Secondary Outcomes (3)

• 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

Study Arms (3)

Acupuncture Group

EXPERIMENTAL

Acupuncture treatment during labor

Procedure: Acupuncture

TENS Group

ACTIVE COMPARATOR

Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor

Other: TENS

Traditional Group

ACTIVE COMPARATOR

Traditional pain treatment during labor

Other: Traditional Group

Interventions

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.

Acupuncture Group

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.

TENS Group

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.

Also known as: Tratitional analgesic

Traditional Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, Danish speaking women with a normal singleton pregnancy giving birth at term 37 - 42 weeks) with a fetus in cephalic presentation.

You may not qualify if:

• Women with medical diseases or complicated pregnancy. Women who has already received conventional analgesia during labor.

Sponsors & Collaborators

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

Study Sites (1)

Dept Obstetrics, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 5, 2005
• Study Start: March 1, 2001
• Primary Completion: February 1, 2004
• Study Completion: May 1, 2004
• Last Updated: May 7, 2008

Record last verified: 2008-05

Locations

DK (1)