The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study

Aim: The purpose of this study is to determine the effect of therapeutic touch applied to infants with infantile colic on infant colic scale score, crying and sleep time.

Method: The study will be conducted as a single-blind, randomized controlled trial. The population of the study will be infants who come to the Pediatrics Outpatient Clinic and are diagnosed as infantile colic according to the evaluation of the pediatrician and have no other health problems. The infants will be divided into two groups as intervention and control groups according to stratified block randomization in the computer environment. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group.

Study Overview

• Status: Completed
• Conditions: Infantile Colic; Therapeutic Touch
• Intervention / Treatment: Other: Therapeutic Touch

Detailed Description

The research will be carried out with two groups as intervention and control groups. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 27 for each group and 54 in total. Considering the possible case losses, 20% of the sample was increased. The sample consisted of 64 babies, 32 intervention and 32 control. Mothers of the infants meeting the study inclusion criteria will be informed both in written and verbally. Written consent will be obtained. The infants will be divided into two groups according to stratified block randomization in the computer environment. The infants will be stratified by gender and age. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group by the researcher. In obtaining research data, 4 tools will be used: "Mother-infant Information Form", "Infantile Colic Scale", Crying Time Registration Form and Sleep Time Registration Form.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey
    • Karaman Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Family volunteering to participate in the research
• The infant was born at term
• The infant is between 4 weeks and 12 weeks
• The birth weight is between 2500-4500 g
• The infant has been diagnosed with infantile colic according to Wessel criteria
• Mothers' ability to read, write and speak Turkish
• New diagnosis of infantile colic

Exclusion Criteria:

• The infant has any chronic illness and congenital anomaly
• Mothers have diagnosed mental and mental problems
• Mother smoking
• The diagnosis of lactose intolerance to infants by the physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The therapeutic touch will not be applied to the control group infants. However, the routine follow-up and behavior of the weekly baby will be evaluated to ensure that parents are blind.
Experimental: Intervention Group; Therapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 6 times in 2 weeks.	Other: Therapeutic Touch; Therapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 6 times in 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infantile Colic Scale	Ellet et al. (2002) developed a Likert-type scale to determine the factors causing colic and to diagnose colic. Cetinkaya and Başbakkal (2007) tested the validity and reliability of the scale for the Turkish population. The scale consists of 5 sub-dimensions and 19 items.The low total score average from the scale indicates that the colic decreases, and the high average score indicates that the colic increases.	In two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying Time	Infants' weekly crying times will be recorded.	In two weeks
Sleeping Time	Infants' weekly sleeping times will be recorded.	In two weeks

Collaborators and Investigators

• Sponsor: Karamanoğlu Mehmetbey University
• Investigators: Study Director: Emine Geçkil, Professor, Necmettin Erbakan University; Principal Investigator: Selda Ateş Beşirik, Res. Assist., Karamanoğlu Mehmetbey University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): October 11, 2020

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: infantile colic; nursing; infant; Therapeutic Touch; Symptom
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 2019/2123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No