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

Infantile Colic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244291
• Other study ID #: 05-2021/27
• Status: Completed
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: August 2, 2022

Study information

• Verified date: August 2022
• Source: Karamanoglu Mehmetbey University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2, 2022
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Weeks to 8 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Infantile Colic
• Therapeutic Touch

Intervention

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.

Locations

Country	Name	City	State
Turkey	Karaman Education and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crying Time	Infants' weekly crying times will be recorded (Every day of the week). Weekly crying time will be taken.	In eight weeks.
Primary	Sleeping Time	Infants' weekly sleeping times will be recorded (Every day of the week). Weekly sleeping time will be taken.	In eight weeks.
Secondary	Infantile Colic Scale	Ellet et al. (2002) developed a Likert-type scale to determine the factors causing colic and to diagnose colic. Cetinkaya and Basbakkal (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.