Hammock Position and Kangaroo Care

Infant Development Clinical Trial

Official title:

Effect of Two Different Positions on Pain, Stress, Comfort and Physiological Parameters of the Premature Infants: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436404
• Other study ID #: He2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Nigde Omer Halisdemir University
• Contact: Hilal KURT SEZER, Ph.D.
• Phone: Central Contact Phone is requi
• Email: hilalkurt26[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.

Description:

Providing adequate therapeutic positioning in preterms can minimize postural abnormalities and asymmetries associated with prematurity and NICU stay, as well as support the development of spontaneous and functional motor abilities of infants. Studies show that positioning directly affects cardiovascular, respiratory and sleep-wake states. When the literature is examined; Although the vital signs, pain levels and comfort levels of babies in the NICU have been examined in many applications, the number of studies comparing the hammock position and Kangaroo care in preterms is very limited. Therefore, this study will try to determine the effect of hammock position and kangaroo care on the pain, stress, comfort and physiological parameters of the infants. It is thought that the study will provide new data to the literature and lead to many researches.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

• Infants having at least 2 days of inpatient treatment from,

• Infants 32-36+6. being born during the gestational week,

• Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),

• Apgar score above 6 at the 5th minute Infants will included.

Exclusion Criteria:

• Infants having at least 2 days of inpatient treatment from,

• Infants 32-36+6. being born during the gestational week,

• Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),

• Apgar score above 6 at the 5th minute Infants will included.

Related Conditions & MeSH terms

• Infant Development
• Premature
• Premature Birth

Intervention

Other:
• Hammock intervention
It is a hammock made of 100% cotton fabric that prevents heat loss and has an internal apparatus to support the position, which can be adapted to the incubator by the researchers.
• Kangaroo care intervention
In the clinic, the baby will receive kangaroo care with his mother in a quiet room with reduced lighting.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University	Selcuk University

References & Publications (5)

Costa KSF, Fernandes DDS, Paula RAP, Guarda LEDA, Dare MF, Castral TC, Ribeiro LM. Hammock and nesting in preterm infants: randomized controlled trial. Rev Bras Enferm. 2019 Dec;72(suppl 3):96-102. doi: 10.1590/0034-7167-2018-0099. English, Portuguese. — View Citation

Gerull R, Cignacco E, Stoffel L, Sellam G, Nelle M. Physiological parameters after nonpharmacological analgesia in preterm infants: a randomized trial. Acta Paediatr. 2013 Aug;102(8):e368-73. doi: 10.1111/apa.12288. Epub 2013 May 28. — View Citation

Huang CM, Tung WS, Kuo LL, Ying-Ju C. Comparison of pain responses of premature infants to the heelstick between containment and swaddling. J Nurs Res. 2004 Mar;12(1):31-40. doi: 10.1097/01.jnr.0000387486.78685.c5. — View Citation

Indyk HE, Woollard DC. Enzymatic determination of free carnitine in milk and infant formulas. J AOAC Int. 1995 Jan-Feb;78(1):69-74. — View Citation

Schwendener RA, Schott H, Hartmann HR, Supersaxo A, Rubas W, Hengartner H. [Liposomes as carriers of lipophilic cytosine arabinoside and fluorodeoxyuridine derivatives. Their cytostatic effect and possibilities of tumor cell specific therapy]. Onkologie. 1987 Aug;10(4):232-9. doi: 10.1159/000216411. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining the descriptive characteristics of babies	1- Infant Introductory Form: The form includes introductory information about the baby (Postnatal day, gestational age, birth weight (g), weight on the day of the intervention, type of birth, gender, postnatal age, physiological weight loss, feeding style, 1st and 5th minute Apgar score, maternal age. It consists of questions containing).	1 hour
Primary	Hammock position and Kangaroo care increase comfort level in preterm infants	2- The COMFORT-behavior scale (COMFORTneo): It is a Likert-type scale developed to be used in evaluating the sedation and comfort needs, pain and distress of newborns monitored in intensive care. The scale was revised for newborns. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.	1 hour
Primary	Hammock position and Kangaroo care decrease pain and stress level in preterm infants	3- ALPS-Neo "Newborn Pain and Stress Assessment Scale": The scale was developed in 2014 to evaluate pain and stress in premature and term newborns. Measurement is made through observation. As the score obtained increases, stress and pain increase.	1 hour
Secondary	Hammock position and Kangaroo care support physiological stability in premature infants.	1- Physiological Parameter Tracking Chart The follow-up chart prepared by the researcher is a form in which physiological parameters such as heart rate (min), oxygen saturation (%SpO2), body temperature (°C), respiratory rate (min) are recorded. Measurements will be taken 3 times in total: before, during and after the hammock position and kangaroo care application. A monitor device used in clinical routine will be used to measure physiological parameters.	1 hour