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

NCT ID: NCT05244291

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2022-08-02

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.

Conditions

Infantile Colic; Therapeutic Touch

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group 1

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 in 1 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 3 times a week or 6 times in 2 weeks.

Intervention Group 2

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 3 times a week or 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

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karamanoğlu Mehmetbey University

OTHER

Sponsor Role: lead

Responsible Party

Selda Ateş Beşirik

Karamanoğlu Mehmetbey University, Faculty of Health Science, Pediatric Nursing Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selda Ateş Beşirik, Res. Assist. Dr.

Role: PRINCIPAL_INVESTIGATOR

Karamanoğlu Mehmetbey University

Emine Geçkil, Professor

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

Karaman Education and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

05-2021/27

Identifier Type: -

Identifier Source: org_study_id