Massage Application and Motor Performance, Stress Assessment in Premature Babies

NCT06075992 | Unknown

• 1 other identifier: fzt.cerenyalcin2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

In our study, the effect of infant massage applied in the intensive care unit on motor performance and stress hormones in premature babies will be examined. The number of patients to participate in the study was determined as 30. Appropriate babies will be determined and divided into 2 groups by drawing lots. After recording the demographic information of the babies who meet the inclusion criteria, the Baby Motor Performance Test (TIMP) and the baby's motor performance evaluation consisting of postural control and selective extremity movements, and the stress level of the babies will be evaluated by looking at cortisol and adrenocorticotropic hormone (ACTH) hormones. In addition, Field baby massage will be given to the application group. It is seen that there are limited studies in the literature on the effect of infant massage applied in the intensive care unit on motor performance and stress hormones in premature infants. The results of this research will provide useful information for premature babies hospitalized in intensive care.

Conditions

Infant; Premature Birth

Keywords

Premature baby; Newborn intensive care; Baby massage; Cortisol hormone; Motor development

Outcome Measures

Primary Outcomes (5)

• Change from Baseline cortisol and ACTH (Adrenocorticotropic hormone) hormones at 4 weeks.

  The stress level will be evaluated by looking at the cortisol and ACTH (Adrenocorticotropic hormone) hormones of the babies. Infants admitted to the NICU will have their blood values routinely checked at regular intervals by the infant's responsible physician. The blood taken for the study will be centrifuged in a gel-free biochemistry tube.

  baseline and after 4 weeks

• Change from Baseline Test of Infant Motor Performance-TIMP at 4 weeks.

  TIMP is a test battery developed for the evaluation of selective and postural control in early infancy. The Infant Motor Performance Test (TIMP) is the only differential assessment and prognosis tool developed for preterm infants of 34 weeks to 4 months of corrected gestational age with a high predictive value for use in the neonatal unit. This test is a test that evaluates motor performance, postural and selective motor control of newborns at risk of motor delay. TIMP, which was developed for the use of physiotherapists, has Turkish reliability and validity. The test begins with a 2-3 minute observation of spontaneous movement of the baby in the supine position. The first part consists of 13 items and evaluates the observational spontaneous motor movements of the baby. Items based on observation are evaluated with two options. The second part is; It consists of 29 items and a total of 42 items based on the baby's performance.

  baseline and after 4 weeks

• Change from Baseline height measurements at 4 weeks.

  Height measurements will be measured in centimeters. In the study, the height measurements of the babies will be made by the researcher using a non-flexible tape measure in the NICU in accordance with the measurement technique. The difference between the baby's first and second measurements will be calculated. It will be compared with the control group.

  baseline and after 4 weeks

• Change from Baseline head circumference measurements at 4 weeks.

  Head circumference measurements will be measured in centimeters. In the study, the head circumference measurements of the babies will be made by the researcher using a non-flexible tape measure in the NICU in accordance with the measurement technique. The difference between the baby's first and second measurements will be calculated. It will be compared with the control group.

  baseline and after 4 weeks

• Change from Baseline body weight at 4 weeks.

  Body weight will be measured in kilograms. body weight of the premature baby will be measured by the researcher. The measurement will be made with babies naked, wearing clean cloths. After the measurement, the actual weight of the baby will be recorded by subtracting the weight of the diaper from the body weight of the baby. The difference between the baby's first and second measurements will be calculated. It will be compared with the control group.

  baseline and after 4 weeks

Study Arms (2)

Premature babies in this group will be massaged.

EXPERIMENTAL

On the first day of the study and at the end of the 4th week, the Infant Motor Performance Test (TIMP) will be used to evaluate the infant's motor performance consisting of postural control and selective extremity movements. Anthropometric measurements of all babies included in the study immediately afterwards; The baby's body weight, height and head circumference will be checked on the first day of the study and at the end of the 4th week. The stress level of babies will be evaluated by looking at cortisol and ACTH (Adrenocorticotropic hormone) hormones. Massage therapy will be given according to the Field medium pressure massage therapy protocol. In addition to the medical treatment, the application group will be massaged by an experienced physiotherapist according to the Field baby massage therapy protocol, at least 1 hour after the babies are fed, 3 days a week, 2 times a day and for 4 weeks.The massage will be applied for 15 minutes.

Other: experimental group

An experimental application will not be made to premature babies in this group.

NO INTERVENTION

No application will be made other than medical treatment. On the first day of the study and at the end of the 4th week, the Infant Motor Performance Test (TIMP) will be used to evaluate the infant's motor performance consisting of postural control and selective extremity movements. Anthropometric measurements of all babies included in the study immediately afterwards; The baby's body weight, height and head circumference will be checked on the first day of the study and at the end of the 4th week. The stress level of babies will be evaluated by looking at cortisol and ACTH (Adrenocorticotropic hormone) hormones.

Interventions

experimental group OTHER

An experimental application will not be made to premature babies in this group.

Also known as: No Intervention group

Premature babies in this group will be massaged.

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants with stable clinical conditions born between gestational weeks,
• Babies of families whose parents can speak and understand Turkish at least one of their parents,
• Body weight over 1000 g,
• Premature babies are only due to non-invasive intubation,
• Stability of the baby's vital signs
• The baby does not have a chest tube.

You may not qualify if:

• Babies whose family consent cannot be obtained,
• Babies born from triplet or more multiple pregnancies,
• Babies using antiepileptic drugs,
• Medically unstable infants,
• Having a major anomaly,
• Having undergone a surgical procedure.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (2)

Hatay Mustafa Kemal University

Hatay, Antakya, 31060, Turkey (Türkiye)

Location

Mustafa Kemal University

Hatay, Antakya, 31060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sabiha bezgin

  Hatay Mustafa Kemal University, Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

gülsün C yalçın

CONTACT

+905522895157; cerenylcnn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: October 10, 2023
• Study Start: January 20, 2024
• Primary Completion: March 20, 2024
• Study Completion: May 20, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)