Clinical trial NCT06171997: The Effect of Safe Swaddling on Stress and Comfort in Newborns
Official title: The Effect of Safe Swaddling After Bathing on Stress and Comfort in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Comfort
Keywords: Newborn
Bath
Swaddling
Stress
Comfort
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 36 baby in experimental group and 36 baby in control group, a total of 72 bany will be included in the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research will be conducted experimentally in the form of randomized controlled studies to determine the effect of safe swaddling of newborns after bathing on stress and comfort. The population of the research consists of newborns receiving treatment and care in the Neonatal Intensive Care Unit of a State Hospital located in the north of Turkey, and the sample consists of 72 babies who meet the sample selection criteria. Descriptive Characteristics Form, Newborn Stress Scale and Newborn Comfort Behavior Scale were used to collect data. Babies will be bathed in the bathtub and then swaddled. The baby will be placed in the incubator and kept for 15 minutes. After 15 minutes, the swaddle will be opened quietly and slowly, without disturbing the body posture. Stress and comfort scores will be given by two observers by video recording the babies before bathing, before swaddling and after swaddling.

Detailed description: Baby bathing is a nursing intervention with individual benefits. Today, there are ongoing discussions about when the infant bath, which is an important part of skin care, should be done first. However, the World Health Organization recommends not bathing newborns for the first 24 hours and waiting until vital signs stabilized. Postponing the bathing of newborns to 48 hours after birth is both effective in maintaining the baby's body temperature and improves skin integrity. Since the thermoregulation abilities of newborns are very limited, it is necessary to maintain body temperature, provide appropriate environmental conditions and warming after bathing.

Although the bathing process, which is an important part of hospital care, protects the health of the newborn, it is also a stressful action for babies and stress symptoms are observed in these babies after bathing. Swaddling the baby in stressful situations such as bathing contributes to the baby's self-calming. The swaddling technique mimics the uterus for newborns and is a technique that ensures the continuation of the intrauterine environment.

Neonatal nursing has come to the forefront in recent years with the development of strategies that increase comfort and has become a frequently used concept in neonatal intensive care units.Among the interventions frequently applied by pediatric nurses to increase comfort are practices such as relaxing positioning, massage, bathing, and wrapping.The practices of nurses to increase the comfort level of the baby and reduce stress with practices with increased level of evidence are very important in terms of nursing care and physical and neuromotor development of the bab.In the light of all this information, this study was planned to investigate the effect of safe swaddling after bathing on stress and comfort in newborns.

Eligibility criteria: Inclusion Criteria:

* The week of gestation is between 37 and 41 weeks,
* Birth weight being 2500 g and above,
* Having spontaneous breathing,
* Its physiological parameters are stable,
* Having completed the first 24 hours of life,
* No invasive interventions should be made before the bathing process.

Exclusion Criteria:

Preterms with a gestational age of 22-37 weeks,

* Connected to mechanical ventilator,
* Those who have been wiped or bathed in the last 12 hours,
* Within the first 78 hours of the post-operative period,
* With central catheter,
* Diagnosed with sepsis,
* Those who use sedative and/or muscle relaxants,
* Those with congenital, chromosomal anomalies,

Primary outcomes:
measure: change in stress
timeFrame: 15th minute after the procedure
measure: change in comfort
timeFrame: 15th minute after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kafkas University
Study officials:
affiliation: Kafkas University
name: Kübra Sevgi, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Kafkas University
name: Funda Kardaş Özdemir, PhD
role: STUDY_DIRECTOR
References: