## Protocol Section
### Identification Module
**NCT ID:** NCT06436404

**Brief Title:** Hammock Position and Kangaroo Care

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

#### Organization Study ID Info
**ID:** He2
#### Organization
**Class:** OTHER
**Full Name:** Nigde Omer Halisdemir University
### Status Module
#### Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Selcuk University

#### Lead Sponsor

**Class:** OTHER

**Name:** Nigde Omer Halisdemir University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Infant Development

- Premature

**Keywords:**

- Premature

- Pain

- Stress

- Comfort

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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 6 will be created for 36 infants and this process will be done by an independent statistician.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Single blinding (Participant)

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Hammock intervention

**Label:** Hammock position group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Kangaroo care will be applied to these preterm infants.

**Intervention Names:**

- Other: Kangaroo care intervention

**Label:** Kangaroo care group

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** The group will not receive any other intervention.

**Label:** Contol group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hammock position group

**Description:** 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.

**Name:** Hammock intervention

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Kangaroo care group

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

**Name:** Kangaroo care intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Determining the descriptive characteristics of babies

**Time Frame:** 1 hour

**Description:** 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.

**Measure:** Hammock position and Kangaroo care increase comfort level in preterm infants

**Time Frame:** 1 hour

**Description:** 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.

**Measure:** Hammock position and Kangaroo care decrease pain and stress level in preterm infants

**Time Frame:** 1 hour

#### Secondary Outcomes

**Description:** 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.

**Measure:** Hammock position and Kangaroo care support physiological stability in premature infants.

**Time Frame:** 1 hour

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 36 Weeks

**Minimum Age:** 32 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hilalkurt26@hotmail.com

**Name:** Hilal KURT SEZER, Ph.D.

**Phone:** Central Contact Phone is requi

**Role:** CONTACT

**Contact 2:**

**Email:** hatonal75@gmail.com

**Name:** Hatice ONAL, M.Sc.

**Phone:** +90 388 20112815

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Selcuk University

**Name:** Sibel KUCUKOGLU, Ph.D.

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Nigde Omer Halisdemir University

**Name:** Halil DEGIRMENCIOGLU, Md.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** It will be shared after the article is published

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 7703730

**Citation:** 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

**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.

**PMID:** 23651076

**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.

**PMID:** 15136961

**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.

**PMID:** 2959889

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Premature

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-31
