Vimala Massage Infantile Colic, Sleep and Development Levels

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Control Intervention: babies in the control group will not receive any intervention

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

Study 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.

Eligibility

Primary outcome measure(s)

• Infantile Colic Scale — 9 month
  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.
• Brief Infant Sleep Questionnaire-Revised — 9 month
  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.
• Parent-Infant Caregiving Touch Scale — 9 month
  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.

Trial sites (1)

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