NCT06993701

Vimala Massage Infantile Colic, Sleep and Development Levels

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Kilis 7 Aralik University · Academic / Other
• Sex: All
• Age: 1 Month – 3 Months
• Healthy volunteers: Accepted

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).

Conditions

• Massage Effect

Interventions

Type	Name	Description
BEHAVIORAL	Vimala Massage Training for Fathers	Fathers will receive Vimala massage training and apply it regularly to their babies at home.
OTHER	Control Intervention	babies in the control group will not receive any intervention
BEHAVIORAL	Vimala Massage Training for Mothers	Mothers will receive Vimala massage training and apply it regularly to their babies at home.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-07-21
• Completion: 2026-01-01
• First posted: 2025-05-29
• Last updated: 2025-05-29

Locations

1 site across 1 country: Turkey (Türkiye)