NCT04286737

The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Karamanoğlu Mehmetbey University · Academic / Other
• Sex: All
• Age: 4 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Infantile Colic
• Therapeutic Touch

Interventions

Type	Name	Description
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 6 times in 2 weeks.

Timeline

• Start date: 2020-03-02
• Primary completion: 2020-06-30
• Completion: 2020-10-11
• First posted: 2020-02-27
• Last updated: 2020-10-14

Locations

1 site across 1 country: Turkey (Türkiye)