Clinical trial NCT05244291: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Colic
Therapeutic Touch
Keywords: Therapeutic Touch
infantile colic
infant
Watson's Theory of Human Care
symptom
nursing
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 96
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
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 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.

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

Primary outcomes:
measure: Crying Time
timeFrame: In eight weeks.
measure: Sleeping Time
timeFrame: In eight weeks.
Secondary outcomes:
measure: Infantile Colic Scale
timeFrame: In eight 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. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: Emine Geçkil, Professor
role: STUDY_DIRECTOR
References: