The Effect of Foot Reflexology on Infantile Colic Symptoms

May 3, 2019 updated by: Nimet KARATAS, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Foot Reflexology Group
Foot reflexology was performed to the reflexology group infants. Foot reflexology application (FRA) involved relaxation for the first 3-5 minutes and the last 2 minutes; the remaining 12-15 minutes included stimulation of the brain and digestive system organs. To ensure relaxation, rotation was performed by using the thumbs of the hand under the feet, cephalocaudally. The session of FRA included stimulating the brain and medulla spinalis (2 min), the solar plexus (1min), the stomach (2min), the liver (2min), the pancreas (2min), the gallbladder (1min), and the ileocecal valve and intestine (5min) reflex points. Application was performed on all infants twice a week, for a total of four times during two consecutive weeks. Between two consecutive applications, a minimum of 48 hours and a maximum of 5 days was allotted (Stone, 2011). A total of 6 follow-ups were performed during the study period.
Other: Foot Reflexology
Reflexology 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.
PLACEBO_COMPARATOR: Placebo Foot Reflexology Group
Placebo foot reflexology was performed to the placebo group infants. Placebo foot reflexology application (PFRA) was constrained to ineffective touch without any stimulation and pressure. The aim of the PFRA was to create only a touch effect. It was applied by patted the foot by using the thumbs of the hand, for 20 minutes with the same rotation and to the same points as FRA. Application was performed on all infants twice a week, for a total of four times during two consecutive weeks. Between two consecutive applications, a minimum of 48 hours and a maximum of 5 days was allotted (Stone, 2011). A total of 6 follow-ups were performed during the study period.
Other: Placebo Foot Reflexology
Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infantile Colic State
Time Frame: In two weeks
Ellet et al. (2002) developed a Likert-type scale to determine the factors causing colic and to diagnose colic. The scale consists of 5 sub-dimensions and 22 items. Sub-dimensions include 'Cow's Milk/Soy Protein Allergy/Intolerance', 'Immature Gastrointestinal System', 'Immature Central Nervous System', 'Difficult Infant Temperament', and 'Parent-Infant Interaction + Problem Infant'. These headings include factors affecting the infant's colic, such as sleep characteristics, consolability, features of crying, infant mood, and parent-infant interaction. The Cronbach's α coefficient of the scale was .69 (Ellett et al., 2003). Cetinkaya and Başbakkal (2007) tested the validity and reliability of the scale for the Turkish population and reported Cronbach's α to be .73 (Cetinkaya & Basbakkal, 2007). In this study, it was determined to be .65.
In two weeks
Colicky Pain
Time Frame: In two weeks
The FLACC scale developed by Merkel et al. in 1997 is used to help determine the level of pain in infants and children. The parameters of scale include infant 'Facial expressions, Leg movements, Activities, Crying, and Consolability' (Voepel-Lewis, Shayevitz, & Malviya, 1997). The maximum score of this scale is ten, shows the highest pain. On the other hands; the minimum score is zero, shows that no pain. Şenaylı et al. (2006) reported that the scale could be used in Turkish population (Şenaylı, Özkan, Şenaylı, & Bıçakçı, 2006).
In two weeks
Colicky Crying
Time Frame: In two weeks
Crying follow-up form was prepared by the researcher to determine the duration of crying in infants. Colic crying differs from ordinary crying as it is louder than normal and inconsolable. It occurs usually suddenly and takes several consecutive hours (Helseth, 2002). Based on this information, when crying ended, parents were asked to record crying times over half an hour, with start and end times. The form required hourly recording by the parents for two weeks.
In two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleeping
Time Frame: In two weeks
Sleeping follow-up form was prepared by the researcher to determine the duration of sleeping in infants. The form required hourly recording by the parents for two weeks.
In two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Ayşegül İŞLER DALGIÇ, Professor, Corresponding author

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 26, 2016

Primary Completion (ACTUAL)

March 31, 2017

Study Completion (ACTUAL)

March 31, 2017

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkdenizUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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