Clinical trial NCT03939611: The Effect of Foot Reflexology on Infantile Colic Symptoms
Official title: The Effect of Foot Reflexology on Infantile Colic Symptoms: Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Colic
Reflexology
Keywords: complementary therapies
infantile colic
nurses
reflexology
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was an experimental, single-blind, randomized, placebo-controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: To compare the effect of foot reflexology and placebo foot reflexology on colic symptoms such as pain, ineffective sleep, and colicky crying periods in infants with colic.

Method: The study was conducted as a single-blind, randomized, placebo-controlled trial in a child hospital between June 2016 and March 2017. To start with, 20 infants with colic were randomly selected for the reflexology group, and 25 babies with colic were randomly selected for the placebo group. Simple randomization was used; the parents and statistician were blinded to group assessment. The researcher could not be blinded because of the role played in the study. Foot reflexology was implemented with reflexology-group infants. Placebo foot reflexology was used with placebo-group infants. Both interventions were performed four times, for 20 minutes, each, by the researcher over the course of two weeks. The data were collected by the researcher using the information form, infantile colic scale, behavioral pain scale, crying and sleeping follow-up forms.


Eligibility criteria: Inclusion Criteria:

Infants were included who were aged 1-3 months, Infants who were diagnosed IC by a pediatrician according to Wessel's rule of threes.

Exclusion Criteria (Beckmann \& Le Quesne, 2005):

Infants who were using any of analgesic drug until 3 hours before the applications and antibiotic or steroid due to treating an illness, Infants who had an acute fever, musculoskeletal disease, active shingles or infection, acute shingles, or tissue in the foot and joint, All infants with any non-IC health problems.

Primary outcomes:
measure: Infantile Colic State
timeFrame: In two weeks
measure: Colicky Pain
timeFrame: In two weeks
measure: Colicky Crying
timeFrame: In two weeks
Secondary outcomes:
measure: Sleeping
timeFrame: In two weeks
Other outcomes:
Locations:
Study officials:
affiliation: Corresponding Author
name: Ayşegül İŞLER DALGIÇ, Professor
role: PRINCIPAL_INVESTIGATOR
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