Clinical trial NCT06345742: The Effect of Parental Participation on Newborn Comfort During Diaper Care
Official title: The Effect of Parental Participation on Newborn Comfort During Diaper Care Practice in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Keywords: diaper care
newborn comfort
parental participation
preterm
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 105
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.

H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.

H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.

H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.

Detailed description: The expectation of all parents is to have a healthy baby at the end of the pregnancy. However, newborns being born unexpectedly early and being admitted to the neonatal intensive care unit is a stressful situation for both newborns and parents. During this process, parents of preterm infants experience anxiety, loss of control, fear of the future, depression, role change and concerns about the improvement of the baby's condition. It is important for parents to actively participate in care within the framework of family-centered care practices in order to reduce the newborn's stress level, increase its comfort and improve its environment and to increase the families' ability to cope with this situation.Infant care, which is repeated many times a day in the Neonatal Intensive Care Unit, is one of the care practices that include tactile stimuli. Studies have observed that preterm infants' stress increases during diaper changes. For this reason, it is important to plan the necessary invasive practices to increase comfort during diaper changes, to include parental participation in these procedures, and to determine the effect of these interventions on the infants' comfort and to include them in the literature.

Eligibility criteria: Inclusion Criteria:

* Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application
* Infants with stable health conditions

Exclusion Criteria:

* Intubated
* Those with very low and extremely low birth weight at the time of procedure
* Having a chronic disease
* Those with congenital anomalies
* Having undergone a surgical procedure
* Having neurological symptoms
* Receiving oxygen support
* Diagnosed with sepsis
* Sedated
* A pharmacological analgesic method was used four hours before.
* Parents who do not want to participate in care

Primary outcomes:
measure: Level of Parental Stress
timeFrame: It will be measured once just before the diaper care
measure: Change in Level of Comfort
timeFrame: immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem University
state: Ataşehir
Study officials:
affiliation: Acibadem University
name: Tuğba Turker, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Girabent-Farres M, Jimenez-Gonzalez A, Romero-Galisteo RP, Amor-Barbosa M, Bagur-Calafat C. Effects of early intervention on parenting stress after preterm birth: A meta-analysis. Child Care Health Dev. 2021 May;47(3):400-410. doi: 10.1111/cch.12853. Epub 2021 Feb 15.
citation: Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
citation: Morelius E, Hellstrom-Westas L, Carlen C, Norman E, Nelson N. Is a nappy change stressful to neonates? Early Hum Dev. 2006 Oct;82(10):669-76. doi: 10.1016/j.earlhumdev.2005.12.013. Epub 2006 Feb 28.
citation: Pichler-Stachl E, Urlesberger P, Mattersberger C, Baik-Schneditz N, Schwaberger B, Urlesberger B, Pichler G. Parental Stress Experience and Age of Mothers and Fathers After Preterm Birth and Admission of Their Neonate to Neonatal Intensive Care Unit; A Prospective Observational Pilot Study. Front Pediatr. 2019 Oct 24;7:439. doi: 10.3389/fped.2019.00439. eCollection 2019.
citation: Prouhet PM, Gregory MR, Russell CL, Yaeger LH. Fathers' Stress in the Neonatal Intensive Care Unit: A Systematic Review. Adv Neonatal Care. 2018 Apr;18(2):105-120. doi: 10.1097/ANC.0000000000000472.