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Sponsors and Collaborators: |
Lund University Ekhagastiftelsen Magn Bergvalls stiftelse General Maternity Hospital Foundation |
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Information provided by: | Lund University |
ClinicalTrials.gov Identifier: | NCT00860301 |
The purpose of this study is to investigate whether acupuncture influences:
Condition | Intervention |
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Infantile Colic |
Other: Acupuncture |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study |
Enrollment: | 90 |
Study Start Date: | December 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Acupuncture group: Experimental |
Other: Acupuncture
Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse is alone with the infant for five minutes. Infants in the acupuncture group get acupuncture. One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.
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Control group: No Intervention
Infants come to the clinic six times, are left alone for five minutes with the acupuncture nurse who hold its hand and talks to it.
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Infantile colic is a common problem. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no known treatment that is both effective and harmless. Acupuncture releases different neurotransmitters and hormones, gives pain reduction and affects digestion. Acupuncture in infantile colic has not been studied in a scientific way even though the method is used in many countries. In this randomised study we will investigate if acupuncture affects symptoms in infantile colic.
Ages Eligible for Study: | up to 8 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Acupuncture Clinic | |
Helsingborg, Sweden, 254 41 |
Principal Investigator: | Inger Hallström, Professor | Lund University |
Responsible Party: | Lund University ( Inger Hallström, Professor ) |
Study ID Numbers: | 1-Landgren |
Study First Received: | March 11, 2009 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00860301 History of Changes |
Health Authority: | Sweden: Lund University |
infantile colic |
Signs and Symptoms Signs and Symptoms, Digestive Abdominal Pain Colic Pain |
Signs and Symptoms Signs and Symptoms, Digestive Abdominal Pain Colic Pain |