The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study
Primary Purpose
Infantile Colic, Therapeutic Touch
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Touch
Sponsored by
About this trial
This is an interventional supportive care trial for Infantile Colic focused on measuring Therapeutic Touch, infantile colic, infant, nursing, Symptom
Eligibility Criteria
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
Sites / Locations
- Karaman Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
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 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
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.
Secondary Outcome Measures
Crying Time
Infants' weekly crying times will be recorded.
Sleeping Time
Infants' weekly sleeping times will be recorded.
Full Information
NCT ID
NCT04286737
First Posted
February 25, 2020
Last Updated
October 11, 2020
Sponsor
Karamanoğlu Mehmetbey University
1. Study Identification
Unique Protocol Identification Number
NCT04286737
Brief Title
The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study
Official Title
The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
October 11, 2020 (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 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.
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.
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, nursing, Symptom
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
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
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 6 times in 2 weeks.
Primary 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.
Time Frame
In two weeks
Secondary Outcome Measure Information:
Title
Crying Time
Description
Infants' weekly crying times will be recorded.
Time Frame
In two weeks
Title
Sleeping Time
Description
Infants' weekly sleeping times will be recorded.
Time Frame
In two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
12 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda Ateş Beşirik, Res. Assist.
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
Learn more about this trial
The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study
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