Acupuncture in Infantile Colic - A Randomised Trial.

Sponsor

Region Skane (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05894798

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn, Diseases Colic, Infantile Acupuncture	Other: Acupuncture	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Acupuncture in Infantile Colic - A Randomised Trial.

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention The acupuncture nurse holds the child by the hand and speaks to it calmly for about a minute. The children receive acupuncture at point LI 4 in the grip of the thumb on the upper side of the hand, bilaterally, with a sterile disposable needle with dimensions 0.20 x 13 mm. The stitch is approximately three mm deep. The needle is allowed to remain in place for about 30 seconds	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
No Intervention: Controll The children in the control group do not receive acupuncture. However, they spend the same amount of time with the acupuncture nurse, are addressed and are touched in the same way as the children in the intervention group, but do not get stung.

Arm

Intervention/Treatment

Experimental: Intervention

The acupuncture nurse holds the child by the hand and speaks to it calmly for about a minute. The children receive acupuncture at point LI 4 in the grip of the thumb on the upper side of the hand, bilaterally, with a sterile disposable needle with dimensions 0.20 x 13 mm. The stitch is approximately three mm deep. The needle is allowed to remain in place for about 30 seconds

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

No Intervention: Controll

The children in the control group do not receive acupuncture. However, they spend the same amount of time with the acupuncture nurse, are addressed and are touched in the same way as the children in the intervention group, but do not get stung.

Outcome Measures

Primary Outcome Measures

Crying and screaming [During acupuncture]
Registration of crying and screaming during the acupuncture at each visit
Colic symptoms [Baseline to 3 weeks]
Change in colic symptoms during the treatment period, comparison between groups. information will be collected by the diaries the parents write during the intervention period

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Weeks to 9 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Otherwise healthy infants, born in week 37 or later, aged 2 - 9 weeks who, according to diary entries, scream/whine for at least 3 hours/day for at least 3 days in the same week. The child has undergone a medical examination at BB or later with no pathological findings. The child takes no medicines or only the dietary supplement Semper Magdroppar. At least one parent understands and speaks Swedish.

Exclusion Criteria:

Children who have lost more than one channel on their weight curve. Children who received acupuncture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peter Nymberg	Helsingborg	Region Skane	Sweden	253 62

Sponsors and Collaborators

Region Skane

Investigators

Principal Investigator: Veronica Milos Nymberg, Ass. Prof., Lund University/ Region Skane

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Region Skane

ClinicalTrials.gov Identifier:

NCT05894798

Other Study ID Numbers:

230524

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Region Skane

Additional relevant MeSH terms:

Colic

Infant, Newborn, Diseases

Study Results

No Results Posted as of Jun 8, 2023