NCT05894798

Acupuncture in Infantile Colic - A Randomised Trial.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 2 Weeks – 9 Weeks
• Healthy volunteers: Not accepted

Summary

About 10 per cent of all new born babies in Sweden have infant colic. This may affect the the whole family and the early connection between the baby and the parents. Although, there are no effective and safe treatment. Acupuncture is an environmental friendly method that affects pain, anxiety, sleep and the function of gastrointestinal system. Several studies have shown various results, and there are a need for high-qualitative randomised controlled trials to investigate the proposed effect further. 128 children will be randomised into two groups; acupuncture at LI4 or no acupuncture, parents will be blinded. Statistical calculations will be performed on the content of the diaries (bowel movement frequency, crying time, feeding). Registration of crying/crying in connection with acupuncture treatment, i.e. when the needle touches the skin or later until the needle is removed and 30 seconds after.

Detailed description

Among all newborn babies in Sweden, about 10% have infant colic. Currently, there is no effective and safe treatment for infant colic, while there is an increase in the use of complementary methods to reduce the infant's suffering. Infant colic is defined as "crying and whining more than three hours/day more than three days/week" and affects about 10% of all newborn babies, starting when the baby is about two weeks old and usually stopping at 3-4 months of age. A complementary method used against pain in the Western world is acupuncture, a treatment method with ancient roots in Asia. It involves thin needles being inserted at specific points on the body. The needle sticks stimulate neurotransmitters, and hormones are released in the central nervous system. Acupuncture is an environmentally friendly treatment with few side effects and promotes the inherent ability to self-heal. Acupuncture has been shown in several studies to be a safe and effective method that affects pain, anxiety, sleep, and the function of the gastrointestinal system. Studies have shown both shorter crying time with lower intensity. Therefore, there is a reasonableness in acupuncture being able to alleviate infant colic. However, systematic reviews have not been able to show significant differences in symptoms between children who received acupuncture and those who did not. The reviews also described that the studies used different points on the body for treatment and that the acupuncture needles remained for various lengths of time (5-30 seconds). This led to their conclusion that more high-quality randomised studies are needed to investigate the treatment method further. Purpose To examine the effect of minimal acupuncture at a single point (LI4) on infants with colic compared to no acupuncture. Method: The parents register the baby's crying, feeding, sleep and bowel movements in a diary (appendix 1) for seven consecutive days, constituting a baseline. According to the diary registration, the infants who have colic are included and come twice a week for three weeks to a nurse at a selected child health centre (BVC). The children will be randomised into two groups; acupuncture at LI4 or no acupuncture. The parents will not know which group the child belongs to. The parents will fill in the same diary type as the baseline during the two intervention weeks. Statistical calculations will be performed on the content of the diaries (bowel movement frequency, crying time, feeding). Registration of crying/crying in connection with acupuncture treatment, i.e. when the needle touches the skin or later until the needle is removed and 30 seconds after. This registration will also be done in the control group, where the handling of children is the same but without acupuncture. Expected result This study can provide further evidence on whether acupuncture is an effective treatment method for alleviating symptoms of infant colic, as well as further highlighting any experience of pain associated with treatment. The attitude towards complementary approaches among parents with infants showing colic symptoms will also be investigated.

Conditions

• Infant, Newborn, Diseases
• Colic, Infantile
• Acupuncture

Interventions

Type	Name	Description
OTHER	Acupuncture	Acupuncture at point LI 4 in the thumb grip on the upper side of the hand, bilaterally, with a sterile disposable needle of dimension 0.20 x 13 mm. The stitch is approximately three mm deep. The needle is allowed to remain in place for about 30 seconds

Timeline

• Start date: 2050-12-01
• Primary completion: 2060-12-01
• Completion: 2060-12-01
• First posted: 2023-06-08
• Last updated: 2026-02-17