Pain Relief at First StageNCT00148577
Pain Relief by Applying TENS on Acupuncture Points During the First Stage of Labour
An observational study of Pain Relief at First Stage, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
We aimed to establish the reduction of labor pain by applying TENS at acupuncture points during the first stage of labour, to assess their efficacy, and to ascertain their acceptability. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Relief at First Stage
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2002to Dec 2003
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria were:
- Voluntary informed participation to the study
- An initial wish to deliver without epidural analgesia
- Planned vaginal childbirth (non-obstetrical complicated pregnancy)
- Fetal vertex presentation
- Term pregnancy (>37 weeks of gestation)
Show all 12Show fewer
- Apply at 1st stage of labour and excluded if cervical dilatation > 5 cm
- Age between 20 and 40 years
- Chinese speaking, capable to understand the study
- No experience of pain relief by systemic or epidural anesthesia in previous delivery
- No experience in acupuncture or TENS in other field
- Had no heart disease nor using pace-maker.
Who cannot join
- Cervical dilatation > 5 cm
- Experience of pain relief by systemic or epidural anesthesia in previous delivery
- Experience in acupuncture or TENS in other field
- Had heart disease or using pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Acupuncture Points During the First Stage of Labour: a Randomised Controlled Trial
We aimed to establish the reduction of labor pain by applying TENS at acupuncture points during the first stage of labour, to assess their efficacy, and to ascertain their acceptability.
Read the detailed description
We conducted a double-blind, placebo-controlled randomised trial involving healthy parturient at term pregnancy using TENS on 4 acupuncture points (Li 4 and Sp 6) (n=50) and the placebo group (n=50). Visual analogue scale (VAS) was used to assess the effect on pain before the application, 30 minutes and 60 minutes after TENS. The objective parameter of outcome was the score of VAS decreased in each groups. A post-partum questionnaire was given 24 hours later to evaluate the satisfaction and the use of this pain relieving method for the next delivery.
- Conditions
- Pain Relief at First Stage
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- Pain Relief, TENS, Acupuncture Points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startAug 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief at First StageStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- An-Shine Chao, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148577
- Sponsor's protocol ID
- NMRPG1159
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 8 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief by Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Acupuncture Points During the First Stage of Labour: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00148577
- Acronym / sponsor ID
- NMRPG1159
- Conditions
- Pain Relief at First Stage
- Keywords
- Pain Relief, TENS, Acupuncture Points
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2002
- Study completion
- Dec 2003
- First posted
- 8 Sep 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.
We aimed to establish the reduction of labor pain by applying TENS at acupuncture points during the first stage of labour, to assess their efficacy, and to ascertain their acceptability.
Detailed description
We conducted a double-blind, placebo-controlled randomised trial involving healthy parturient at term pregnancy using TENS on 4 acupuncture points (Li 4 and Sp 6) (n=50) and the placebo group (n=50). Visual analogue scale (VAS) was used to assess the effect on pain before the application, 30 minutes and 60 minutes after TENS. The objective parameter of outcome was the score of VAS decreased in each groups. A post-partum questionnaire was given 24 hours later to evaluate the satisfaction and the use of this pain relieving method for the next delivery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Voluntary informed participation to the study
- An initial wish to deliver without epidural analgesia
- Planned vaginal childbirth (non-obstetrical complicated pregnancy)
- Fetal vertex presentation
- Term pregnancy (>37 weeks of gestation)
Key exclusion criteria (4 listed)
- Cervical dilatation > 5 cm
- Experience of pain relief by systemic or epidural anesthesia in previous delivery
- Experience in acupuncture or TENS in other field
- Had heart disease or using pace-maker
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2005.
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.
An-Shine Chao, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Relief at First Stage, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 12 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Sep 2005. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
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.
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 8 Sep 2005.