Vimala Massage Infantile Colic, Sleep and Development Levels

NCT06993701 | Not Yet Recruiting DMC

• 1 other identifier: Ataturk University
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The effect of Vimala massage applied by parents on infantile colic, sleep and developmental levels of infants will be investigated. Method: The data of the randomised controlled study is planned to be conducted in 3 Family Health Centres in Kilis province between 01 Jun 2025-01 January 2026. The population of the study will consist of infants diagnosed with IC who come to the FHC centre for diagnosis, treatment or follow-up between the specified dates and meet the inclusion criteria.

Conditions

Massage Effect

Keywords

vimala massage; infantile colic; sleep; developmental levels

Outcome Measures

Primary Outcomes (3)

• Infantile Colic Scale

  The Infantile Colic Scale consists of 19 items rated on a 6-point Likert scale, ranging from 1 to 6. It is designed to assess the severity of colic symptoms in infants. Higher average scores on the scale indicate more severe colic symptoms, whereas lower averages suggest symptom reduction. The items are grouped under five subdimensions: cow's milk/soy protein allergy or intolerance, immature digestive system, underdeveloped central nervous system, difficult infant temperament, and issues related to parent-infant interaction.

  9 month

• Brief Infant Sleep Questionnaire-Revised

  The Brief Infant Sleep Questionnaire-Revised (BISQ-R) includes 33 items and assesses infant sleep patterns based on parental reports from the past two weeks. The scoring framework comprises three expert-defined, conceptually grounded subscales. These subscales evaluate three distinct but interrelated aspects of infant sleep: (1) infant sleep behaviors (Infant Sleep), (2) parental perceptions of their child's sleep (Parental Perception), and (3) ecologically based parental behaviors known to influence sleep quality (Parental Behavior), each adjusted according to the infant's age. The total score ranges from 0 to 100, with higher scores indicating better overall sleep quality, more positive parental perceptions, and supportive parental practices that promote healthy sleep in infants.

  9 month

• Parent-Infant Caregiving Touch Scale

  The Parent-Infant Caregiving Touch Scale (PICTS) is a 12-item self-report instrument designed to assess the frequency of affectionate and intentional touch behaviors expressed by parents toward their infants. It includes items evaluating how often the mother strokes areas such as the infant's back, head, abdomen, arms, and legs, as well as how frequently she holds, cuddles, rocks, kisses, and physically interacts with the baby. Responses are recorded using a 5-point Likert scale ranging from 1 ("Never") to 5 ("Very Often"). Higher scores indicate more frequent engagement in positive tactile caregiving behaviors.

  9 month

Study Arms (3)

mother massage group

EXPERIMENTAL

In family health centers, the time and hour of the massage training will be determined with the mothers of infants diagnosed with IC. At this stage, the researcher will provide face-to-face, applied, one-to-one training on massage to the mothers of the babies in the mother group according to the constructivist learning model. Each training will be explained specifically for the mother and her baby. The infant massage will be demonstrated by the researcher on the model, and the mother will be asked to apply it to her baby at the same time.

Behavioral: Vimala Massage Training for Mothers

father massage group

EXPERIMENTAL

Unlike the mother group, in this group, one-to-one training will be given to the fathers of the babies. Each training will be explained specifically for the father and his baby.

Behavioral: Vimala Massage Training for Fathers

Control group

PLACEBO COMPARATOR

In the control group, only one of the parents, mother or father, who fulfills the inclusion criteria will participate.

Other: Control Intervention

Interventions

Vimala Massage Training for Fathers BEHAVIORAL

Fathers will receive Vimala massage training and apply it regularly to their babies at home.

father massage group

Control Intervention OTHER

babies in the control group will not receive any intervention

Control group

Vimala Massage Training for Mothers BEHAVIORAL

Mothers will receive Vimala massage training and apply it regularly to their babies at home.

mother massage group

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants born at term (38-42 weeks of gestation)
• Aged between 1 and 3 months
• Birth weight between 2500 and 4500 grams
• No health problems other than infantile colic
• Growth and development percentile consistent with current age
• Diagnosed with infantile colic according to Rome IV criteria
• Not yet started any treatment for infantile colic
• No presence of diarrhea or constipation
• Parents with at least primary school education
• Able to speak and write in Turkish
• Provided written and verbal informed consent
• Volunteered to participate in the study

You may not qualify if:

• Infants with acute or chronic medical conditions (e.g., congenital anomalies, metabolic disorders)
• Infants currently receiving any pharmacological or complementary treatment for infantile colic
• Parents with communication difficulties or cognitive impairments that hinder comprehension of study procedures
• Parents who have previously participated in a similar infant massage or infantile colic intervention study
• Parents who are unable or unwilling to complete follow-up assessments or study procedures

Sponsors & Collaborators

• Kilis 7 Aralik University: lead
• Ataturk University: collaborator

Study Sites (1)

Atatürk Üniversty

Erzurum, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

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

Study Officials

• Türkan KADİROĞLU, Asst. Prof. Dr.

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

Elif Simay KOÇ, Lecturer

CONTACT

+90348 814 26 66; kocelifsimay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 3 group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion: July 21, 2025
• Study Completion: January 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)