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The Effect of Spa and Massage on Babies on Colic Symptoms

Primary Purpose

Infantile Colic, Infantile Spasm

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baby SPA
Massage
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infantile Colic focused on measuring İnfantile Colic, Baby SPA, hydrotherapy, massage

Eligibility Criteria

40 Days - 4 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yuzuncu Yıl UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Baby SPA

Massage

Control

Arm Description

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.

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.

It is the control group in which no intervention was applied.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2022
Last Updated
September 8, 2022
Sponsor
Yuzuncu Yıl University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05538936
Brief Title
The Effect of Spa and Massage on Babies on Colic Symptoms
Official Title
The Effect of Spa and Massage on Babies on Colic Symptoms: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic, Infantile Spasm
Keywords
İnfantile Colic, Baby SPA, hydrotherapy, massage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled experimental design with pretest-posttest experiment and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baby SPA
Arm Type
Experimental
Arm Description
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.
Arm Title
Massage
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
It is the control group in which no intervention was applied.
Intervention Type
Other
Intervention Name(s)
Baby SPA
Other Intervention Name(s)
Hydrotherapy
Intervention Description
"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.
Intervention Type
Other
Intervention Name(s)
Massage
Other Intervention Name(s)
Therapeutic Touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Data Collection
Description
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.
Time Frame
6 or 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Days
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rıdvan Akdoğan, PhD
Phone
+905413983680
Email
ridvanakdogan30@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rıdvan Akdoğan, PhD
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuzuncu Yıl University
City
Van
ZIP/Postal Code
65090
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rıdvan AKDOĞAN, PhD
Phone
+905413983680

12. IPD Sharing Statement

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The Effect of Spa and Massage on Babies on Colic Symptoms

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