Infantile ColicNCT05538936
The Effect of Spa and Massage on Babies on Colic Symptoms
A study testing Baby SPA and Massage in people with Infantile Colic and Infantile Spasm, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Although various complementary health approaches have been examined to alleviate colic symptoms, there seems to be a limited number of studies on SPA and massage applications. For this reason, the study was planned to determine the effectiveness of nurses' baby SPA and massage practices in reducing colic symptoms in… Read more about this study
- Who is it for?
- Ages 40 days to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Infantile Colic, Infantile Spasm
- What is being tested?
- Baby SPA and Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 days to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The willingness of the family to participate in the research
- The baby is between 40 days - 4 months
- The baby was born at term
- Birth weight between 2500 - 4500 g
- The baby's diagnosis of infantile colic by the doctor
- The baby has not started any treatment for infantile colic
Who cannot join
- The presence of any congenital anomaly in the baby
- The baby has a diagnosis of lactose intolerance
- The baby has an acute or chronic illness
- There is a wound on the baby's skin or a condition that prevents massage.
- Having a situation that prevents communication with the mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Spa and Massage on Babies on Colic Symptoms: A Randomised Controlled Trial
Although various complementary health approaches have been examined to alleviate colic symptoms, there seems to be a limited number of studies on SPA and massage applications. For this reason, the study was planned to determine the effectiveness of nurses' baby SPA and massage practices in reducing colic symptoms in babies.
Read the detailed description
Baby SPA is a physiotherapy method that stimulates the baby's motor movements through water (hydrotherapy) and performs body circulation in an integrated way to balance the mind and emotions. Playing with water, the baby's muscles develop, circulation accelerates and the body becomes flexible. It also increases the intestinal motility of the baby. This allows the baby to pass gas more easily. In addition, all parts of the body of the baby floating in the water develop. Because in the water, the hands and legs move freely, giving the whole body the ability to move. Due to the low gravitational effect while swimming in the water, the baby's ability to control their muscles develops, which allows the baby to move more and all of their muscles to work optimally. On the other hand, when the baby is in the water, he feels that he is in an environment similar to the intrauterine environment he is used to.
Infant massage also used to reduce the symptoms of infantile colic, is often called stimulus touch. Baby massage can be defined as a relaxed conversation between parent and baby. Infant massage is also called touch therapy, which refers to a technique that combines the physical benefits of human touch with emotional benefits such as mind bonding. Massage is an application that makes the baby more sensitive, develops a sense of security, enables better communication with eye contact, increases comfort, creates a deep bond between parent and baby, as well as supports the baby's physical, mental and emotional development.
Although various complementary health approaches have been examined to alleviate colic symptoms, there seems to be a limited number of studies on SPA and massage applications. For this reason, the study was planned to determine the effectiveness of nurses' baby SPA and massage practices in reducing colic symptoms in babies.
- Conditions
- Infantile Colic, Infantile Spasm
- Being tested
- Baby SPA, Massage
- Keywords
- İnfantile Colic, Baby SPA, hydrotherapy, massage
- Medical subject headings
- Colic, Spasms, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby SPAOther
Also called Hydrotherapy
"Salus Per Aquam", "Sanitas Per Aquam", "Salut Per Aqua" or "Solus Per Aqua" (SPA) means health that comes with water. Baby SPA is a physiotherapy method that stimulates the baby's motor movements through water (hydrotherapy) and performs it in an integrated way to balance the body, mind, and emotions. Baby SPA is applied in specially designed bathtubs. The size of the tub is designed in such a way that children can move their hands and feet freely and not be narrow. A neck ring/ring is used to keep the baby on the water surface during SPA treatment.
MassageOther
Also called Therapeutic Touch
The best way to communicate with a baby is to touch it. When babies are born, unlike their other senses, the most developed one is the sense of touch. Because this process begins while in the womb. The baby communicates by touch and begins to recognize his environment. The sense of touch is a priority for the development of all senses. They need to perceive their environment, especially in newborns and infancy periods. Touching the body in a systematic way for a therapeutic purpose is called "Massage". Massage is soft touches to body tissues to relax muscles, accelerate circulation, reduce infantile colic symptoms and pain, regulate sleep, and increase its duration. Baby massage has many benefits such as reducing colic symptoms, increasing weight gain, providing motor development and coordination, strengthening the parent and baby bond, supporting growth and development, and reducing stress.
| Study group | Role | What they receive |
|---|---|---|
| Baby SPA | Experimental | Baby SPA application time: It is done regularly from the first month, at least once a month. The ideal time for application is the first six months. The water in the tub is prepared to be 33°C. The baby, whose clothes are taken off, wearing a waterproof diaper suitable for the tub and a neck ring, is taken into the tub. The application usually takes 10-15 minutes, depending on the baby's reactions to the water for the first time. After the parent and baby get used to the process, the time can be increased to 30 minutes. In this process, the baby's hands, abdomen, and legs are made to recognize the water and the baby's movements are monitored. Care is taken that the baby does not drink the water. After the application period is over, the baby is removed from the tub and dried with a towel. Finally, the baby is massaged for 10-15 minutes and dressed. Receives: Other: Baby SPA |
| Massage | Experimental | Massage can be applied to all age periods. Before starting the massage application in babies, some preparations are made. Ambient temperature (24-26 OC) is adjusted, it is regulated so that there is no airflow, dim light, and low noise levels are ensured. 1-2 towels, a soft cushion or massage table, baby oil lotion, clean diapers, and clean clothes are prepared for the massage. There is no standard time interval for the application of massage. It can be done at least one hour after the baby's feeding, at any time of the day when he is not stressed and sleeps. Massage application time is 15-30 minutes depending on the baby's reactions may vary between. Receives: Other: Massage |
| Control | No intervention | It is the control group in which no intervention was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
The researcher will collect the research data at Van Aquarium Baby SPA and Van İki Nisan Caddesi Private Clinic Center. For the experimental groups, once a week for a total of four applications, the application will end at the end of a month. Introductory Information Form, Infant Colic Scale, and Infant Colic Symptoms Follow-up Form will be applied to the individuals in the experimental and control groups to collect data. Items in the infant colic scale are graded on a Likert-type score from 1 to 6. The rating ranges from 1 (strongly disagree) to 6 (strongly agree). A low mean score from the scale indicates a decrease in colic, while a high mean score indicates an increase in colic. The Baby Colic Symptoms Follow-up Form is a form that measures the duration and frequency of changes in the baby's colic symptoms. If the time and frequency are reduced, it is concluded that the application is effective.
Measured: 6 or 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Aug 2022
- Primary completion30 Jan 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infantile ColicStudies 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
- Randomized controlled experimental design with pretest-posttest experiment and control group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Rıdvan Akdogan, Yuzuncu Yil University
- Investigators
- Rıdvan Akdoğan, PhD, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538936
- Sponsor's protocol ID
- Istanbul University-Cerrahpaşa
- Status last verified
- Dec 2025
- First submitted
- 1 Sep 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akdogan R, Yildiz S. The effect of SPA and massage applied on babies on colic symptoms: A randomized controlled trial. J Pediatr Nurs. 2025 May-Jun;82:e164-e174. doi: 10.1016/j.pedn.2025.04.008. Epub 2025 Apr 18.
PubMed 40253272
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spa and Massage on Babies on Colic Symptoms: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05538936
- Acronym / sponsor ID
- Istanbul University-Cerrahpaşa
- Conditions
- Infantile Colic, Infantile Spasm
- Keywords
- İnfantile Colic, Baby SPA, hydrotherapy, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 14 Sep 2022 (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.
Although various complementary health approaches have been examined to alleviate colic symptoms, there seems to be a limited number of studies on SPA and massage applications. For this reason, the study was planned to determine the effectiveness of nurses' baby SPA and massage practices in reducing colic symptoms in babies.
Detailed description
Baby SPA is a physiotherapy method that stimulates the baby's motor movements through water (hydrotherapy) and performs body circulation in an integrated way to balance the mind and emotions. Playing with water, the baby's muscles develop, circulation accelerates and the body becomes flexible. It also increases the intestinal motility of the baby. This allows the baby to pass gas more easily. In addition, all parts of the body of the baby floating in the water develop. Because in the water, the hands and legs move freely, giving the whole body the ability to move. Due to the low gravitational effect while swimming in the water, the baby's ability to control their muscles develops, which allows the baby to move more and all of their muscles to work optimally. On the other hand, when the baby is in the water, he feels that he is in an environment similar to the intrauterine environment he is used to.
Infant massage also used to reduce the symptoms of infantile colic, is often called stimulus touch. Baby massage can be defined as a relaxed conversation between parent and baby. Infant massage is also called touch therapy, which refers to a technique that combines the physical benefits of human touch with emotional benefits such as mind bonding. Massage is an application that makes the baby more sensitive, develops a sense of security, enables better communication with eye contact, increases comfort, creates a deep bond between parent and baby, as well as supports the baby's physical, mental and emotional development.
Although various complementary health approaches have been examined to alleviate colic symptoms, there seems to be a limited number of studies on SPA and massage applications. For this reason, the study was planned to determine the effectiveness of nurses' baby SPA and massage practices in reducing colic symptoms in babies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled experimental design with pretest-posttest experiment and control group
| Arm | Type | Receives |
|---|---|---|
| Baby SPA | Experimental | Other: Baby SPABaby SPA application time: It is done regularly from the first month, at least once a month. The ideal time for application is the first six months. The water in the tub is prepared to be 33°C. The baby, whose clothes are taken off, wearing a waterproof diaper suitable for the tub and a neck ring, is taken into the tub. The application usually takes 10-15 minutes, depending on the baby's reactions to the water for the first time. After the parent and baby get used to the process, the time can be increased to 30 minutes. In this process, the baby's hands, abdomen, and legs are made to recognize the water and the baby's movements are monitored. Care is taken that the baby does not drink the water. After the application period is over, the baby is removed from the tub and dried with a towel. Finally, the baby is massaged for 10-15 minutes and dressed. |
| Massage | Experimental | Other: MassageMassage can be applied to all age periods. Before starting the massage application in babies, some preparations are made. Ambient temperature (24-26 OC) is adjusted, it is regulated so that there is no airflow, dim light, and low noise levels are ensured. 1-2 towels, a soft cushion or massage table, baby oil lotion, clean diapers, and clean clothes are prepared for the massage. There is no standard time interval for the application of massage. It can be done at least one hour after the baby's feeding, at any time of the day when he is not stressed and sleeps. Massage application time is 15-30 minutes depending on the baby's reactions may vary between. |
| Control | No intervention | –It is the control group in which no intervention was applied. |
Who may qualify
- Ages
- 40 days to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The willingness of the family to participate in the research
- The baby is between 40 days - 4 months
- The baby was born at term
- Birth weight between 2500 - 4500 g
- The baby's diagnosis of infantile colic by the doctor
Key exclusion criteria (5 listed)
- The presence of any congenital anomaly in the baby
- The baby has a diagnosis of lactose intolerance
- The baby has an acute or chronic illness
- There is a wound on the baby's skin or a condition that prevents massage.
- Having a situation that prevents communication with the mother
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 |
|---|---|---|
| Baby SPAAlso: Hydrotherapy"Salus Per Aquam", "Sanitas Per Aquam", "Salut Per Aqua" or "Solus Per Aqua" (SPA) means health that comes with water. Baby SPA is a physiotherapy method that stimulates the baby's motor movements through water (hydrotherapy) and performs it in an integrated way to balance the body, mind, and emotions. Baby SPA is applied in specially designed bathtubs. The size of the tub is designed in such a way that children can move their hands and feet freely and not be narrow. A neck ring/ring is used to keep the baby on the water surface during SPA treatment. | Other | Baby SPA |
| MassageAlso: Therapeutic TouchThe best way to communicate with a baby is to touch it. When babies are born, unlike their other senses, the most developed one is the sense of touch. Because this process begins while in the womb. The baby communicates by touch and begins to recognize his environment. The sense of touch is a priority for the development of all senses. They need to perceive their environment, especially in newborns and infancy periods. Touching the body in a systematic way for a therapeutic purpose is called "Massage". Massage is soft touches to body tissues to relax muscles, accelerate circulation, reduce infantile colic symptoms and pain, regulate sleep, and increase its duration. Baby massage has many benefits such as reducing colic symptoms, increasing weight gain, providing motor development and coordination, strengthening the parent and baby bond, supporting growth and development, and reducing stress. | Other | Massage |
Primary outcome
Data Collection
Time frame: 6 or 7 months
The researcher will collect the research data at Van Aquarium Baby SPA and Van İki Nisan Caddesi Private Clinic Center. For the experimental groups, once a week for a total of four applications, the application will end at the end of a month. Introductory Information Form, Infant Colic Scale, and Infant Colic Symptoms Follow-up Form will be applied to the individuals in the experimental and control groups to collect data. Items in the infant colic scale are graded on a Likert-type score from 1 to 6. The rating ranges from 1 (strongly disagree) to 6 (strongly agree). A low mean score from the scale indicates a decrease in colic, while a high mean score indicates an increase in colic. The Baby Colic Symptoms Follow-up Form is a form that measures the duration and frequency of changes in the baby's colic symptoms. If the time and frequency are reduced, it is concluded that the application is effective.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 40253272Akdogan R, Yildiz S. The effect of SPA and massage applied on babies on colic symptoms: A randomized controlled trial. J Pediatr Nurs. 2025 May-Jun;82:e164-e174. doi: 10.1016/j.pedn.2025.04.008. Epub 2025 Apr 18.
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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. This study is not recruiting at the moment.
Rıdvan Akdoğan, PhD principal investigator
Yuzuncu Yil 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 Baby SPA and Massage in people with Infantile Colic and Infantile Spasm, run by Yuzuncu Yil 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 18 Dec 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection (time frame: 6 or 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538936, which also lists 1 linked publication.
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 18 Dec 2025.