NCT05538936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

September 1, 2022

Last Update Submit

December 10, 2025

Conditions

Keywords

İnfantile ColicBaby SPAhydrotherapymassage

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 or 7 months

Study Arms (3)

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.

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.

Other: Massage

Control

NO INTERVENTION

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

Interventions

"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.

Also known as: Hydrotherapy
Baby SPA
MassageOTHER

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.

Also known as: Therapeutic Touch
Massage

Eligibility Criteria

Age40 Days - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yıl University

Van, Turkey, 65090, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ColicSpasms, Infantile

Interventions

HydrotherapyMassageTherapeutic Touch

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEpilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesMind-Body TherapiesSpiritual Therapies

Study Officials

  • Rıdvan Akdoğan, PhD

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design with pretest-posttest experiment and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant (PhD Candidate)

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 14, 2022

Study Start

August 1, 2022

Primary Completion

January 30, 2023

Study Completion

December 11, 2023

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations