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NCT Number: NCT06993701

Vimala Massage Infantile Colic, Sleep and Development Levels

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.

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Key information

Conditions

Massage Effect Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

1 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk Üniversty

Erzurum, 25000, Turkey (Türkiye)

About this study

The sample size was calculated using the G*Power 3.1.9.7 software, and the required sample size was determined to be 66. To account for potential data loss, the sample size was increased by 10% for each group. As a result, 24 infants were planned for each group (mother massage group, father massage group, and control group), totaling 72 participants. Data will be collected using the Introductory Information Form, Infant Follow-up Form, Infant Colic Scale, Expanded Short Infant Sleep Questionnaire, Parent-Infant Caregiving Touch Scale, and the Massage Practice Competence Evaluation Form.

All data will be collected face-to-face by the researcher, who holds an instructor certificate from the International Association of Infant Massage (IAIM). After the pre-test data are collected, participants will be assigned to the relevant groups. No intervention will be applied to the infants in the control group.

Parents in the mother massage group and father massage group will attend Vimala Massage training sessions once a week for five weeks at pre-scheduled times at Family Health Centers (FHCs). At the end of the fifth week, parents in all groups (mother, father, and control) will be asked to complete the post-test data collection forms.

This study is supported by Atatürk University (Project No: TDK-2025-15472).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Vimala Massage Training for Fathers

Behavioral

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

Control intervention

Other

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.

Primary outcomes

  1. Infantile Colic Scale

    Time frame: 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.

  2. Brief Infant Sleep Questionnaire-Revised

    Time frame: 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.

  3. Parent-Infant Caregiving Touch Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elif Simay KOÇ, Lecturer

CONTACT

[email protected]

+90348 814 26 66

Sponsors and collaborators

Lead sponsor

Kilis 7 Aralik University

Other

Collaborators

  • Ataturk University

Registry information

Official study title

The Effect of Vimala Massage Applied by Parents on Infantile Colic, Sleep and Development Levels of Infants

Acronym: VIMCOLSLEEP

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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