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Completed

NCT Number: NCT03939611

The Effect of Foot Reflexology on Infantile Colic Symptoms

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.

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Key information

Conditions

Infantile Colic Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Reflexology

Age range

1 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foot reflexology

Other

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 Foot Reflexology

Other

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 7, 2019
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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