Clinical trial NCT06993701: Vimala Massage Infantile Colic, Sleep and Development Levels
Official title: The Effect of Vimala Massage Applied by Parents on Infantile Colic, Sleep and Development Levels of Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Massage Effect
Keywords: vimala massage
infantile colic
sleep
developmental levels
Lead sponsor: Kilis 7 Aralik University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2025-05-29
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Infantile Colic Scale
timeFrame: 9 month
measure: Brief Infant Sleep Questionnaire-Revised
timeFrame: 9 month
measure: Parent-Infant Caregiving Touch Scale
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Üniversty
Study officials:
affiliation: Ataturk University
name: Türkan KADİROĞLU, Asst. Prof. Dr.
role: STUDY_DIRECTOR
References: