The Effect of Foot Reflexology on Infantile Colic Symptoms
- Conditions
- ReflexologyInfantile Colic
- Interventions
- Other: Placebo Foot ReflexologyOther: Foot Reflexology
- Registration Number
- NCT03939611
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Foot Reflexology Group Placebo Foot Reflexology 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. Foot Reflexology Group Foot Reflexology 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.
- Primary Outcome Measures
Name Time Method Infantile Colic State 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.
Colicky Pain 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).
Colicky Crying 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
Name Time Method Sleeping 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.