Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2010-02-28
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will be a randomized, prospective pilot study testing if acupuncture, sham acupuncture, and laser stimulation all are useful means in preventing nausea and/or vomiting in early pregnancy.
The acu-stimulation will be performed during at a standardised regimen using acupuncture point PC 6 bilaterally. The placebo needle will be placed in the same position at PC 6 bilaterally, however not penetrating the surface of the skin. The third group of women will have a laser pointing at PC 6. All the patients will achieve exactly the same, standardised information and counselling.
Study participants
According to birth rate-statistics there should be approximately 7000 annual pregnancies in Oslo area. Prevalence is estimated to be approximately 0,75. According to this, there should be at least 5000 pregnant women suffering from nausea and/or vomiting each year, and at least 400 each month.
It is likely to assume that only 50 % of pregnant women suffering from nausea and/or vomiting do want any kind of therapy for their complaints (i.e. 200/month). If another 10% of these again respond to advertisements and agree to inclusion in an acupuncture study, this will ensure an adequate number of subjects for the study within the three-month study period.
Recruitment plan
Pregnant women in their first trimester will be recruited through advertisements in media and/or flyers made available by all general practitioners, all pharmacies and all clinics caring for pregnant women.
Randomisation is performed in blocks, in order to eliminate confounders of personnel- or structural nature. In the study we will use a randomisation system with variable block sizes. The randomisation procedure will be preformed by closed envelopes in a row.
TREATMENT PLAN
We wish to administer the anti-nausea therapy at a standardised intervention. The patients will receive all together three sessions on three consecutive days for all three stimulation modalities.
Acupuncture may be associated with adverse effects, but is, nevertheless, regarded as relatively safe when performed according to best practice. However, minor punctuate haemorrhages as well as local discomfort may occur. Any adverse event or side effect is monitored according to registration by the patient.
The women are informed about the study both in a written letter and verbally at time of inclusion. Information is given regarding the use of randomisation and the study focusing on the different stimulation modalities.
60 women are included, divided into three groups:
1. ACUPUNTURE GROUP The acupuncture needles are inserted in PC 6 bilaterally at the acupuncture point Pericardium 6 (PC6) on each forearm (fig 2). According to the "cun" measurement system of Traditional Chinese Medicine (TCM), the points are located on the palmar surface of anterior forearm at a distance equivalent to the combined width of the women's middle three fingers, proximal to the most prominent wrist crease, and between the tendons of palmaris longus and flexor carpi radialis. We try to keep the depth of the needling to approximately 1,5 cm. At insertion of the acupuncture needle, DeQi is obtained and the needle is then left without any further manipulation/ stimulation (even method) in situ for 15 minutes.
2. SHAM ACUPUNCTURE GROUP A sham acupuncture needle is placed at PC 6 bilaterally and the tactile stimuli of the skin during the procedure should be obtained. The sham acupuncture needle is then left at site for 15 minutes without any further manipulation/stimulation.
3. LASER ACUPUNCTURE A laser is placed in a stand, pointing at PC 6 bilaterally, and left at site for 15 minutes without any further manipulation/stimulation.
Effect on nausea and/or vomiting is supposed to occur within minutes or few hours. All women included in the study should record their symptoms in a run-in period of 4 days before therapy (day 1-4). The days of therapy is supposed to be day 5-7. They thereafter record symptoms on the 4 consecutive days (day 8-11).
At enrollment, the women will be asked about background variables as well as factors that possibly could affect the outcome of the research. During the whole study period of 11 days, the women are told to record their symptoms according to previous research methodology.
Participants are asked to make three recordings of their symptoms every evening. The first registration is to determine what problems had had the particular day; 1= no problems, 2=nausea and 3=vomiting, regardless of how often and how many times they vomited. In the second registration, the women are asked to estimate how many hours they had suffered each day. In the third registration the women also estimate an overall evaluation of severity their symptoms on a visual analogue scale (VAS).
Every woman participates in the study for 12 consecutive days consisting of a 4 day run-in period, a 3 day treatment period, a 4 day follow up period, and one last day of an ending interview.
The programme for these days is:
Day 0: Day of contact. The woman starts registration of symptoms the next day. Day 1-4: The women register their symptoms every evening. Day 5: Randomization. Day 5-7: The women are treated once daily with one of the three treatments they are randomized to get. The women register how they experience the stimulation of the acupuncture points within one hour after the treatment. The women also register their symptoms of nausea and vomiting every evening. Day 8-11: The women register their symptoms every evening. Dag 12: The woman is phoned and asked to participate in an ending interview.
Data will also be collected with regard to how the women experienced the three different stimulations of the acupuncture points, how and if they obtained the needle-feeling (De Qi), and how and if the consider the treatment effected their condition. The patients are also asked to state credibility of the stimulation and to describe DeQi.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acupuncture
Needle acupuncture at acupuncture point pericardium 6
Acupuncture
The acupuncture needles are inserted in PC 6 bilaterally at the acupuncture point Pericardium 6 (PC6) on each forearm (fig 2). According to the "cun" measurement system of Traditional Chinese Medicine (TCM), the points are located on the palmar surface of anterior forearm at a distance equivalent to the combined width of the women's middle three fingers, proximal to the most prominent wrist crease, and between the tendons of palmaris longus and flexor carpi radialis. We try to keep the depth of the needling to approximately 1,5 cm. At insertion of the acupuncture needle, DeQi is obtained and the needle is then left without any further manipulation/ stimulation (even method) in situ for 15 minutes.
Sham acupuncture
Non-penetrating sham needling at acupuncture point pericardium 6
Sham acupuncture
A sham acupuncture needle is placed at PC 6 bilaterally and the tactile stimuli of the skin during the procedure should be obtained. The sham acupuncture needle is then left at site for 15 minutes without any further manipulation/stimulation.
Laser acupuncture
Laser stimulation at acupuncture point pericardium 6
Laser acupuncture
A laser is placed in a stand, pointing at PC 6 bilaterally, and left at site for 15 minutes without any further manipulation/stimulation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acupuncture
The acupuncture needles are inserted in PC 6 bilaterally at the acupuncture point Pericardium 6 (PC6) on each forearm (fig 2). According to the "cun" measurement system of Traditional Chinese Medicine (TCM), the points are located on the palmar surface of anterior forearm at a distance equivalent to the combined width of the women's middle three fingers, proximal to the most prominent wrist crease, and between the tendons of palmaris longus and flexor carpi radialis. We try to keep the depth of the needling to approximately 1,5 cm. At insertion of the acupuncture needle, DeQi is obtained and the needle is then left without any further manipulation/ stimulation (even method) in situ for 15 minutes.
Sham acupuncture
A sham acupuncture needle is placed at PC 6 bilaterally and the tactile stimuli of the skin during the procedure should be obtained. The sham acupuncture needle is then left at site for 15 minutes without any further manipulation/stimulation.
Laser acupuncture
A laser is placed in a stand, pointing at PC 6 bilaterally, and left at site for 15 minutes without any further manipulation/stimulation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Gestational length of 7-12 weeks estimated according to the Naegele method.
* Nausea related to pregnancy must have lasted for at least one week
Exclusion Criteria
* Women who has been pregnant by infertility treatment
* The woman can not be treated in hospital for nausea or other diseases during pregnancy.
* Women with any pregnancy related disease or abnormalities discovered at regular pregnancy follow-up.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Norwegian Acupuncture College
UNKNOWN
National Research Centre of Complementary and Alternative Medicine, Norway
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
National Research Centre of Complementary and Alternative Medicine, Norway
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arne Johan Norheim, PhD
Role: PRINCIPAL_INVESTIGATOR
The National research center in Complementary and Alternative Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The National Research Center in Complementary and Alternative Medicine
Tromsø, Tromso, Norway
Norwegian Acupuncture College
Oslo, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Vinjar Fonnebo, Professor
Role: primary
Hilde Skjerve, Director
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009/1-7
Identifier Type: -
Identifier Source: org_study_id