Clinical trial NCT04286737: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Colic
Therapeutic Touch
Keywords: Therapeutic Touch
infantile colic
infant
nursing
Symptom
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted as a single-blind, randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Infantile Colic Scale
timeFrame: In two weeks
Secondary outcomes:
measure: Crying Time
timeFrame: In two weeks
measure: Sleeping Time
timeFrame: In two weeks
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Education and Research Hospital
Study officials:
affiliation: Karamanoğlu Mehmetbey University
name: Selda Ateş Beşirik, Res. Assist.
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: Emine Geçkil, Professor
role: STUDY_DIRECTOR
References: