Acupuncture AnalgesiaPhase 1/2NCT00261755
Acupuncture as Pain Relief and Relaxation During Childbirth
A Phase 1/2 study testing Acupuncture, TENS and Traditional Group in people with Acupuncture Analgesia and Natural Childbirth, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acupuncture Analgesia, Natural Childbirth
- What is being tested?
- Acupuncture, TENS and Traditional Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2001to May 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy, Danish speaking women with a normal singleton pregnancy giving birth at term 37 - 42 weeks) with a fetus in cephalic presentation.
Who cannot join
- Women with medical diseases or complicated pregnancy. Women who has already received conventional analgesia during labor.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept Obstetrics, Aarhus University Hospital, Skejby
Aarhus, 8200
About this study
Official title: Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study
The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.
Read the 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.
- Conditions
- Acupuncture Analgesia, Natural Childbirth
- Being tested
- Acupuncture, TENS, Traditional Group
- Keywords
- Acupuncture, pain relief, labour, randomized controlled trial, TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
TENSOther
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 GroupOther
Also called Tratitional analgesic
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Experimental | Acupuncture treatment during labor Receives: Procedure: Acupuncture |
| TENS Group | Active comparator | Transcutaneous Electric Nerve Stimulation (TENS treatment)during labor Receives: Other: TENS |
| Traditional Group | Active comparator | Traditional pain treatment during labor Receives: Other: Traditional Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for conventional analgesic in each group.
Measured: during labor
Secondary outcomes (3)
Obstetric outcome: duration of labour, use of oxytocin, incidence of caesarean section, bleeding, apgar score, cord blood pH
Measured: from randomization until birth
visual analogue scale is used to evaluate subjective effect on pain.
Measured: 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.
Measured: two months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startMar 2001
- Primary completionFeb 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- 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, The Hede Nielsen Family Foundation, Videns- og Forskningscenter for Alternativ Behandling, DADJ (Den almindelige Danske Jordemoderforening)
- Investigators
- Lone Hvidman, MD,PhD, Study chair, Department of Obstetrics, Aarhus University Hospital, Skejby, DenmarkMorten Hedegaard, MD, PhD, Study chair, Department Obstetrics, Rigshospitalet, DenmarkLissa Borup, Midwife, Principal investigator, Department of Obstetrics, Aarhus University Hospital, SkejbyWinnie M. Wurlitzer, Midwife, Principal investigator, Department of obstetrics, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261755
- Sponsor's protocol ID
- Akupunktur2001-41-1305
- Status last verified
- May 2008
- First submitted
- 2 Dec 2005
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as Pain Relief and Relaxation During Childbirth. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00261755
- Acronym / sponsor ID
- Akupunktur2001-41-1305
- Conditions
- Acupuncture Analgesia, Natural Childbirth
- Keywords
- Acupuncture, pain relief, labour, randomized controlled trial, TENS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- 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, The Hede Nielsen Family Foundation, Videns- og Forskningscenter for Alternativ Behandling, DADJ (Den almindelige Danske Jordemoderforening)
- Study start
- Mar 2001
- Primary completion
- Feb 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 5 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effect of acupuncture for pain relief and relaxation during childbirth.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Procedure: AcupunctureAcupuncture treatment during labor |
| TENS Group | Active comparator | Other: TENSTranscutaneous Electric Nerve Stimulation (TENS treatment)during labor |
| Traditional Group | Active comparator | Other: Traditional GroupTraditional pain treatment during labor |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, Danish speaking women with a normal singleton pregnancy giving birth at term 37 - 42 weeks) with a fetus in cephalic presentation.
Key exclusion criteria (1 listed)
- Women with medical diseases or complicated pregnancy. Women who has already received conventional analgesia during labor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureBased 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. | Procedure or surgery | Acupuncture Group |
| TENSThe 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 | TENS Group |
| Traditional GroupAlso: Tratitional analgesicAll 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 | Traditional Group |
Primary outcome
The need for conventional analgesic in each group.
Time frame: during labor
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Hvidman, MD,PhD study chair
Department of Obstetrics, Aarhus University Hospital, Skejby, Denmark
Morten Hedegaard, MD, PhD study chair
Department Obstetrics, Rigshospitalet, Denmark
Lissa Borup, Midwife principal investigator
Department of Obstetrics, Aarhus University Hospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupuncture, TENS and Traditional Group in people with Acupuncture Analgesia and Natural Childbirth, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The need for conventional analgesic in each group. (time frame: during labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2008.