Massage EffectVIMCOLSLEEPNCT06993701
Vimala Massage Infantile Colic, Sleep and Development Levels
A study testing Vimala Massage Training for Fathers and Vimala Massage Training for Mothers in people with Massage Effect, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Massage Effect
- What is being tested?
- Vimala Massage Training for Fathers and Vimala Massage Training for Mothers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Vimala Massage Applied by Parents on Infantile Colic, Sleep and Development Levels of Infants
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.
Read the 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
- Being tested
- Vimala Massage Training for Fathers, Control Intervention, Vimala Massage Training for Mothers
- Keywords
- vimala massage, infantile colic, sleep, developmental levels
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vimala Massage Training for FathersBehavioural
Fathers will receive Vimala massage training and apply it regularly to their babies at home.
Control InterventionOther
babies in the control group will not receive any intervention
Vimala Massage Training for MothersBehavioural
Mothers will receive Vimala massage training and apply it regularly to their babies at home.
| Study group | Role | What they receive |
|---|---|---|
| mother massage group | Experimental | In family health centers, the time and hour of the massage training will be determined with the mothers of infants diagnosed with IC. At this stage, the researcher will provide face-to-face, applied, one-to-one training on massage to the mothers of the babies in the mother group according to the constructivist learning model. Each training will be explained specifically for the mother and her baby. The infant massage will be demonstrated by the researcher on the model, and the mother will be asked to apply it to her baby at the same time. Receives: Behavioral: Vimala Massage Training for Mothers |
| father massage group | Experimental | Unlike the mother group, in this group, one-to-one training will be given to the fathers of the babies. Each training will be explained specifically for the father and his baby. Receives: Behavioral: Vimala Massage Training for Fathers |
| Control group | Placebo comparator | In the control group, only one of the parents, mother or father, who fulfills the inclusion criteria will participate. Receives: Other: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infantile Colic Scale
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.
Measured: 9 month
Brief Infant Sleep Questionnaire-Revised
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.
Measured: 9 month
Parent-Infant Caregiving Touch Scale
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.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion21 Jul 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massage EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Elif Simay KOÇ, Kilis 7 Aralik University
- Investigators
- Türkan KADİROĞLU, Asst. Prof. Dr., Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993701
- Sponsor's protocol ID
- Ataturk University
- Acronym
- VIMCOLSLEEP
- Status last verified
- May 2025
- First submitted
- 9 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vimala Massage Applied by Parents on Infantile Colic, Sleep and Development Levels of Infants
- ClinicalTrials.gov ID
- NCT06993701
- Acronym / sponsor ID
- VIMCOLSLEEP / Ataturk University
- Conditions
- Massage Effect
- Keywords
- vimala massage, infantile colic, sleep, developmental levels
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| mother massage group | Experimental | Behavioral: Vimala Massage Training for MothersIn family health centers, the time and hour of the massage training will be determined with the mothers of infants diagnosed with IC. At this stage, the researcher will provide face-to-face, applied, one-to-one training on massage to the mothers of the babies in the mother group according to the constructivist learning model. Each training will be explained specifically for the mother and her baby. The infant massage will be demonstrated by the researcher on the model, and the mother will be asked to apply it to her baby at the same time. |
| father massage group | Experimental | Behavioral: Vimala Massage Training for FathersUnlike the mother group, in this group, one-to-one training will be given to the fathers of the babies. Each training will be explained specifically for the father and his baby. |
| Control group | Placebo comparator | Other: Control InterventionIn the control group, only one of the parents, mother or father, who fulfills the inclusion criteria will participate. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vimala Massage Training for FathersFathers will receive Vimala massage training and apply it regularly to their babies at home. | Behavioural | father massage group |
| Control Interventionbabies in the control group will not receive any intervention | Other | Control group |
| Vimala Massage Training for MothersMothers will receive Vimala massage training and apply it regularly to their babies at home. | Behavioural | mother massage group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Türkan KADİROĞLU, Asst. Prof. Dr. study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vimala Massage Training for Fathers and Vimala Massage Training for Mothers in people with Massage Effect, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Simay KOÇ, Lecturer (+90348 814 26 66, kocelifsimay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infantile Colic Scale (time frame: 9 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.