Status:
NOT_YET_RECRUITING
Vimala Massage Infantile Colic, Sleep and Development Levels
Lead Sponsor:
Kilis 7 Aralik University
Collaborating Sponsors:
Ataturk University
Conditions:
Massage Effect
Eligibility:
All Genders
1-3 years
Phase:
NA
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 p...
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 e...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06993701
Start Date
June 1 2025
End Date
January 1 2026
Last Update
May 29 2025
Active Locations (1)
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1
Atatürk Üniversty
Erzurum, Erzurum, Turkey (Türkiye), 25000