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The Effect of Foot Reflexology on Infantile Colic Symptoms

NCT03939611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-05-07

No results posted yet for this study

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

  • Infantile Colic
  • Reflexology

Interventions

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.

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.

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Principal Investigators

  • Ayşegül İŞLER DALGIÇ, Professor · Corresponding Author

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-26
Primary Completion
2017-03-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03939611 on ClinicalTrials.gov