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

NCT05244291 | Completed

• 1 other identifier: 05-2021/27
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Colic; Therapeutic Touch

Keywords

Therapeutic Touch; infantile colic; infant; Watson's Theory of Human Care; symptom; nursing

Outcome Measures

Primary Outcomes (2)

• Crying Time

  Infants' weekly crying times will be recorded (Every day of the week). Weekly crying time will be taken.

  In eight weeks.

• Sleeping Time

  Infants' weekly sleeping times will be recorded (Every day of the week). Weekly sleeping time will be taken.

  In eight weeks.

Secondary Outcomes (1)

• Infantile Colic Scale

  In eight weeks.

Study Arms (3)

Intervention Group 1

EXPERIMENTAL

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.

Other: Therapeutic Touch

Intervention Group 2

EXPERIMENTAL

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.

Other: Therapeutic Touch

Control Group

NO INTERVENTION

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.

Interventions

Therapeutic Touch 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 1; Intervention Group 2

Eligibility Criteria

• Age: 4 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Karaman Education and Research Hospital

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colic

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Selda Ateş Beşirik, Res. Assist. Dr.

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

• Emine Geçkil, Professor

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karamanoğlu Mehmetbey University, Faculty of Health Science, Pediatric Nursing Department

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

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 25, 2022
• Primary Completion: May 28, 2022
• Study Completion: August 2, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

TU (1)