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CompletedNCT03939611

The Effect of Foot Reflexology on Infantile Colic Symptoms

The Effect of Foot Reflexology on Infantile Colic Symptoms: Randomized, Placebo-Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Akdeniz University · Academic / Other
Sex
All
Age
1 Month – 3 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERFoot ReflexologyReflexology is one of the complementary health approaches; it is based on systematic pressure and stimulation with fingers to energy points in feet and hands and is a topic nowadays studied. Reflexology argues that the reflex maps in the hands and feet with all of the parts of the body are in contact. The pressure applied to each point stimulates the circulation of blood and energy like a sensor, gives a sense of relaxation, provides homeostasis. With a touch that is a different way of communication with children, is supported to create physical awareness via reflexology techniques, and is provided healthy nutrition of the stimulated tissue.
OTHERPlacebo Foot ReflexologyPlacebo reflexology was performed by touch without pressure to the same rotation and to the same points as foot reflexology application. It was performed only to compare foot reflexology with a placebo effect.

Timeline

Start date
2016-06-26
Primary completion
2017-03-31
Completion
2017-03-31
First posted
2019-05-07
Last updated
2019-05-07

Source: ClinicalTrials.gov record NCT03939611. Inclusion in this directory is not an endorsement.

The Effect of Foot Reflexology on Infantile Colic Symptoms (NCT03939611) · Clinical Trials Directory