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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2020-10-11

Brief Summary

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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.

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Detailed Description

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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

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Infantile Colic Therapeutic Touch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be conducted as a single-blind, randomized controlled trial.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Therapeutic Touch

Intervention Type OTHER

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes