Health TrialsbyHealthPanel

Vimala Massage Infantile Colic, Sleep and Development Levels

ConditionMassage Effect
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorKilis 7 Aralik University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Infants and parents who do not meet the inclusion criteria

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vimala Massage Training for Fathers

    Behavioral

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

  • Control Intervention

    Other intervention

    babies in the control group will not receive any intervention

  • Vimala Massage Training for Mothers

    Behavioral

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

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: mother massage groupExperimental treatment 1 intervention
Group B: father massage groupExperimental treatment 1 intervention
Group C: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
9 month
2

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.

Time frame
9 month
3

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.

Time frame
9 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kilis 7 Aralik University

Lead sponsor

Ataturk University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: