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Completed

NCT Number: NCT06345742

The Effect of Parental Participation on Newborn Comfort During Diaper Care

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.

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Key information

Conditions

Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No parental participation

Other
  • 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

Other
  • 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

Other
  • 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.

Primary outcomes

  1. Level of Parental Stress

    Time frame: It will be measured once just before the diaper care

    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 Başbakkal 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

  2. Change in Level of Comfort

    Time frame: immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed

    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

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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