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

Primary Purpose

Infantile Colic, Therapeutic Touch

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Touch
Sponsored by
Karamanoğlu Mehmetbey University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infantile Colic focused on measuring Therapeutic Touch, infantile colic, infant, Watson's Theory of Human Care, symptom, nursing

Eligibility Criteria

4 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karaman Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention Group 1

Intervention Group 2

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 8, 2022
Last Updated
August 2, 2022
Sponsor
Karamanoğlu Mehmetbey University
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1. Study Identification

Unique Protocol Identification Number
NCT05244291
Brief Title
Effect of Therapeutic Touch at Different Times on Infantile Colic According to Watson's Theory
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
May 28, 2022 (Actual)
Study Completion Date
August 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic, Therapeutic Touch
Keywords
Therapeutic Touch, infantile colic, infant, Watson's Theory of Human Care, symptom, nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be conducted as a single-blind, randomized controlled trial.
Masking
Participant
Masking Description
Single blind will be done in the study. Only parents will be blinded. Two weeks follow up will be done in both groups. Since the researcher should implement the intervention, evaluate and manage the process, it will not be blinded.
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic Touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Crying Time
Description
Infants' weekly crying times will be recorded (Every day of the week). Weekly crying time will be taken.
Time Frame
In eight weeks.
Title
Sleeping Time
Description
Infants' weekly sleeping times will be recorded (Every day of the week). Weekly sleeping time will be taken.
Time Frame
In eight weeks.
Secondary Outcome Measure Information:
Title
Infantile Colic Scale
Description
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.
Time Frame
In eight weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda Ateş Beşirik, Res. Assist. Dr.
Organizational Affiliation
Karamanoğlu Mehmetbey University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emine Geçkil, Professor
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
Facility Information:
Facility Name
Karaman Education and Research Hospital
City
Karaman
Country
Turkey

12. IPD Sharing Statement

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

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