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Clinical Trials/NCT05244291
NCT05244291
Completed
N/A

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

Karamanoğlu Mehmetbey University1 site in 1 country96 target enrollmentMarch 25, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infantile Colic
Sponsor
Karamanoğlu Mehmetbey University
Enrollment
96
Locations
1
Primary Endpoint
Crying Time
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2022
End Date
August 2, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karamanoğlu Mehmetbey University
Responsible Party
Principal Investigator
Principal Investigator

Selda Ateş Beşirik

Karamanoğlu Mehmetbey University, Faculty of Health Science, Pediatric Nursing Department

Karamanoğlu Mehmetbey University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Crying Time

Time Frame: In eight weeks.

Infants' weekly crying times will be recorded (Every day of the week). Weekly crying time will be taken.

Sleeping Time

Time Frame: In eight weeks.

Infants' weekly sleeping times will be recorded (Every day of the week). Weekly sleeping time will be taken.

Secondary Outcomes

  • Infantile Colic Scale(In eight weeks.)

Study Sites (1)

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