Hammock Position and Kangaroo Care

NCT06436404 | Completed

• 1 other identifier: He2
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Development; Premature

Keywords

Premature; Pain; Stress; Comfort

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Hammock position and Kangaroo care support physiological stability in premature infants.

  1 hour

Study Arms (3)

Hammock position group

EXPERIMENTAL

A hammock inside the incubator, developed by researchers to prevent heat loss and support posture, will be used.

Other: Hammock intervention

Kangaroo care group

EXPERIMENTAL

Kangaroo care will be applied to these preterm infants.

Other: Kangaroo care intervention

Contol group

NO INTERVENTION

The group will not receive any other intervention.

Interventions

Hammock intervention OTHER

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.

Hammock position group

Kangaroo care intervention OTHER

In the clinic, the baby will receive kangaroo care with his mother in a quiet room with reduced lighting.

Kangaroo care group

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead
• Selcuk University: collaborator

Study Sites (1)

Niğde Ömer Halisdemir University

Niğde, Center, 51000, Turkey (Türkiye)

Location

Related Publications (5)

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

  PMID: 7703730 BACKGROUND

• 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.

  PMID: 31851240 BACKGROUND

• 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.

  PMID: 23651076 BACKGROUND

• 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.

  PMID: 15136961 BACKGROUND

• 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.

  PMID: 2959889 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sibel KUCUKOGLU, Ph.D.

  Selcuk University

  STUDY DIRECTOR

• Halil DEGIRMENCIOGLU, Md.

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding (Participant)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled, single-blind parallel design experimental study.In the study, premature infants will be divided into three groups by randomization. Each group will be referred to as A, B or C for convenience. The type of intervention will be determined by drawing lots for A, B and C. For example, A= Hammock Position, B= Kangaroo Care c=Control Group. When applying the hammock position to a group; The other group will receive kangaroo care, while the other group will receive standard care. For randomization, blocks of 3 created for 42 infants and this process done by an independent statistician.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 31, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: May 20, 2025
• Last Updated: May 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)