The Effect of Spa and Massage on Babies on Colic Symptoms

Infantile Colic Clinical Trial

Official title:

The Effect of Spa and Massage on Babies on Colic Symptoms: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538936
• Other study ID #: Istanbul University-Cerrahpasa
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 11, 2023

Study information

• Verified date: May 2024
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 babies.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 11, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Days to 4 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colic
• Infantile Colic
• Infantile Spasm
• Spasms, Infantile

Intervention

Other:
• Baby SPA
"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.
• Massage
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.

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University	Van

Sponsors (2)

Lead Sponsor	Collaborator
Yuzuncu Yil University	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collection	The researcher will collect the research data at Van Aquarium Baby SPA and Van Iki 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.	6 or 7 months