Clinical trial NCT06436404: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Premature
Keywords: Premature
Pain
Stress
Comfort
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Selcuk University
First posted: 2024-05-31
Enrollment: 42
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
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 3 created for 42 infants and this process done by an independent statistician.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Determining the descriptive characteristics of babies
timeFrame: 1 hour
measure: Hammock position and Kangaroo care increase comfort level in preterm infants
timeFrame: 1 hour
measure: Hammock position and Kangaroo care decrease pain and stress level in preterm infants
timeFrame: 1 hour
Secondary outcomes:
measure: Hammock position and Kangaroo care support physiological stability in premature infants.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Niğde Ömer Halisdemir University
state: Center
Study officials:
affiliation: Selcuk University
name: Sibel KUCUKOGLU, Ph.D.
role: STUDY_DIRECTOR
affiliation: Nigde Omer Halisdemir University
name: Halil DEGIRMENCIOGLU, Md.
role: PRINCIPAL_INVESTIGATOR
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