Effect of Therapeutic Touch at Different Times on Infantile Colic According to Watson's Theory

The Effect of Therapeutic Touch at Different Times on Colic Symptoms in Infants With Infantile Colic According to Watson's Theory of Human Care: A Randomized Controlled Study

Aim: The purpose of the study is to determine the effect of therapeutic touch applied to infants with infantile colic at different times on infant colic scale score, crying and sleep duration, according to Watson's theory of human care. Thus, it is aimed to contribute to the development of an effective care approach in eliminating or reducing the symptoms in infants with infantile colic.

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 three groups as intervention (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks) 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 three groups as intervention (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks) 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 32 for each group and 96 in total. 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 three groups according to block randomization in the computer environment. The randomization, therapeutic touch will be applied to the intervention group (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks). 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): 96
• 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 1 month (Child)
• Accepts Healthy Volunteers: No
• 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 8 weeks
• The birth weight is between 2500-4500 g
• The infant has been diagnosed with infantile colic by a physician
• Mothers' ability to read, write and speak Turkish
• New diagnosis of infantile colic

Exclusion Criteria:

• The baby has any chronic disease
• The baby has a congenital anomaly
• The mother has a diagnosed mental and mental problem
• Mother's smoking
• The diagnosis of infants with lactose intolerance 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group 1; 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 3 times in 1 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 3 times a week or 6 times in 2 weeks.
Experimental: Intervention Group 2; 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 3 times a week or 6 times in 2 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying Time	Infants' weekly crying times will be recorded (Every day of the week). Weekly crying time will be taken.	In eight weeks.
Sleeping Time	Infants' weekly sleeping times will be recorded (Every day of the week). Weekly sleeping time will be taken.	In eight weeks.

Secondary 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. Infantile colic scale will be applied to all babies in the study when they complete these weeks.	In eight weeks.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Actual): May 28, 2022
• Study Completion (Actual): August 2, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: infantile colic; nursing; infant; Therapeutic Touch; Watson's Theory of Human Care; symptom
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 05-2021/27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No