The Effect of Parental Participation on Newborn Comfort During Diaper Care

Preterm Clinical Trial

Official title:

The Effect of Parental Participation on Newborn Comfort During Diaper Care Practice in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345742
• Other study ID #: ATADEK-2023-10/396
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2024
• Source: Acibadem University
• Contact: Zehra Kan Öntürk, Assist Prof
• Phone: 02165004163
• Email: zehrakan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm

Intervention

Other:
• No parental participation
Before collecting data, Preterm Infant information form will be filled out. The "Premature Infant Comfort Scale" will be evaluated before the procedure. Diaper care will be performed by the primary nurse. "Premature Infant Comfort Scale" will be evaluated during and after the diaper care application.
• Mother participation
Before collecting data, Preterm Infant information form will be filled out. The "Premature Infant Comfort Scale" will be evaluated before the procedure. Mothers' stress level will be determined using the "Neonatal Intensive Care Unit Parent Stress Scale" Mothers will be given practical diaper care training on the infant model doll. Diaper care will be provided by the mothers of the infants "Premature Infant Comfort Scale" will be evaluated during and after the application.
• Father participation
Before collecting data, Preterm Infant information form will be filled out. The "Premature Infant Comfort Scale" will be evaluated before the procedure. Fathers' stress level will be determined using the "Neonatal Intensive Care Unit Parent Stress Scale" Fathers will be given practical diaper care training on the infant model doll. Diaper care will be provided by the fathers of the infants "Premature Infant Comfort Scale" will be evaluated during and after the application.

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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 — View Citation

Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52. — View 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. — View 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 Pr — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Parental Stress	The level of parental stress will be measured using the Neonatal Intensive Care Unit Parental Stress Scale.The scale was developed by Miles, Funk and Carlson in 1993 to determine the perception levels of stressors arising from the physical and psychosocial environment by mothers and fathers. The Turkish validity and reliability study of the scale was conducted by Turan and Basbakkal in 2006. The scale consists of 5 rating points and is rated from 1 (not stressful) to 5 (extremely stressful). The score that can be obtained from the scale varies between 0 and 170. The scale can be applied to mothers and fathers with infants in the neonatal intensive care unit	It will be measured once just before the diaper care
Primary	Change in Level of Comfort	The infants' comfort level will be measured using the Premature Infant Comfort Scale.The scale is a multi-dimensional scale used to measure comfort in preterm newborns. The Premature Infant Comfort Scale was developed by Monique et al. in the Netherlands in 2007. The validity and reliability of the Turkish scale was determined by Küçük Alemdar and Güdücü Tüfekçi in 2015. The scale consists of 1 to 5 rating points. The infant's comfort is evaluated based on the total score according to the scale. According to the total score, 35 indicates the lowest score, 7 indicates the highest comfort level, and a high score indicates a low comfort level. The subscales of the scale include the preterm infant's alertness, calmness, respiratory status, physical movement, muscle tone, facial movements, and average heart rate	immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed