Massage Effect
Conditions
Keywords
vimala massage, infantile colic, sleep, developmental levels
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).
Interventions
BEHAVIORALVimala Massage Training for Fathers
Fathers will receive Vimala massage training and apply it regularly to their babies at home.
OTHERControl Intervention
babies in the control group will not receive any intervention
BEHAVIORALVimala Massage Training for Mothers
Mothers will receive Vimala massage training and apply it regularly to their babies at home.
Sponsors
Ataturk University
Kilis 7 Aralik University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
3 group
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactElif Simay KOÇ, Lecturer
Outcome results
None listed