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The Effect of Foot Reflexology on Infantile Colic Symptoms

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ClinicalTrials.gov Identifier: NCT03939611
Recruitment Status : Completed
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
NIMET KARATAS, Akdeniz University

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.


Condition or disease Intervention/treatment Phase
Infantile Colic Reflexology Other: Foot Reflexology Other: Placebo Foot Reflexology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This was an experimental, single-blind, randomized, placebo-controlled trial.
Masking: Single (Participant)
Masking Description: All parents were only told that foot application would be done, without giving any expectations. In the statistical analysis, the groups were named Group-1 and Group-2, and the statistician was blinded when evaluating the outputs. The report was written by the statistician, who did not know which application was performed to which group blinding was provided in the report writing. The scales were evaluated by the researcher, who could not be blinded due to the nature of the study.
Primary Purpose: Supportive Care
Official Title: The Effect of Foot Reflexology on Infantile Colic Symptoms: Randomized, Placebo-Controlled Trial
Actual Study Start Date : June 26, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939611


Sponsors and Collaborators
Akdeniz University
Investigators
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Principal Investigator: Ayşegül İŞLER DALGIÇ, Professor Corresponding Author

Publications:

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Responsible Party: NIMET KARATAS, Research Assistant, Akdeniz University
ClinicalTrials.gov Identifier: NCT03939611     History of Changes
Other Study ID Numbers: AkdenizUniversity
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NIMET KARATAS, Akdeniz University:
complementary therapies
infantile colic
nurses
reflexology

Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases