NCT04286737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

February 25, 2020

Last Update Submit

October 11, 2020

Conditions

Infantile ColicTherapeutic Touch

Keywords

Therapeutic Touchinfantile colicinfantnursingSymptom

Outcome Measures

Primary Outcomes (1)

  • Infantile Colic Scale

    Ellet et al. (2002) developed a Likert-type scale to determine the factors causing colic and to diagnose colic. Cetinkaya and Başbakkal (2007) tested the validity and reliability of the scale for the Turkish population. The scale consists of 5 sub-dimensions and 19 items.The low total score average from the scale indicates that the colic decreases, and the high average score indicates that the colic increases.

    In two weeks

Secondary Outcomes (2)

  • Crying Time

    In two weeks

  • Sleeping Time

    In two weeks

Study Arms (2)

Intervention Group

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 TouchOTHER

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 Group

Eligibility Criteria

Age4 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Education and Research Hospital

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colic

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Selda Ateş Beşirik, Res. Assist.

    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
Model Details: The study will be conducted as a single-blind, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Karamanoğlu Mehmetbey University, Faculty of Health Science, Pediatric Nursing Department

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

March 2, 2020

Primary Completion

June 30, 2020

Study Completion

October 11, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

TU(1)