Acupuncture in Infantile Colic
The purpose of this study is to investigate whether acupuncture influences:
- the rate of infants who still fulfil the colic criterion after three intervention weeks
- the time when the infants are crying, fussing or have intense bouts of colicky symptoms
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study|
- If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups. [ Time Frame: First, second and third intervention weeks ] [ Designated as safety issue: Yes ]
- If the time when infants are crying, fussing or have intense bouts of colicky symptoms in each of the intervention weeks differ between groups. [ Time Frame: First, second and third intervention weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
|Experimental: Acupuncture group||
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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.
No Intervention: Control group
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860301
|Helsingborg, Sweden, 254 41|
|Principal Investigator:||Inger Hallström, Professor||Lund University|