The Effect of Diaper Change Position on Preterm Infants

NCT04528602 | Completed

• 1 other identifier: 2019-5/12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.

Conditions

Infant, Premature, Diseases

Keywords

preterm; diaper change; comfort; position

Outcome Measures

Primary Outcomes (4)

• Change in Heart rate

  Preterm infant will be monitored and heart rate will be monitored.

  Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.

• Change in Respiratory Rate

  Preterm infant will be monitored and respiratory rate will be monitored.

  Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.

• Change in Oxygen Saturation

  Preterm infant will be monitored and respiratory rate will be monitored.

  Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.

• Change in Comfort

  Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The PICS evaluates seven parameters as Alertness, Calmness/Agitation, Respiratory Status (only on mechanic ventilation support) or Crying (not evaluated because it is scored in children with spontaneous breathing), Physical Movements, Muscle Tone, Facial Gestures and Mean Heart Rate. It is a five-point likert scale in which each element is scored from one to five (from bad to good). According to the PICS, the infant's comfort is evaluated over the total score. Accordingly, 35 points signify the lowest comfort score, while seven points signify the highest comfort score. High score obtained from the scale signifies that the comfort level is low. If the total score is ≥17, this is the cut-off value of the scale. It was found that the Turkish version was a valid and reliable.

  Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.

Study Arms (2)

Control (Extended leg position) Group

EXPERIMENTAL

In the control (Extended leg position) group of the study, diaper change will be performed after the legs of the babies are brought to extension.

Procedure: Control (Extended leg position) Group

Experimental (Legs are flexed toward abdomen) Group

EXPERIMENTAL

In the experimental (Legs are flexed toward abdomen) group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen while maintaining their flexion leg position.

Procedure: Experimental (Legs are flexed toward abdomen) Group

Interventions

Control (Extended leg position) Group PROCEDURE

Common procedure steps -Legal representatives of the infants will sign an informed consent form. Materials (soap, napkin, non-sterile gloves, diaper, wet cotton towels for newborns, waste container, diaper change mat) will be prepared. Hands will be washed and gloves will be worn. Tapes of the infant's dirty diaper will be opened. For the Control Group -The infant will be grasped on the legs, the legs will be given extension position and lifted up. The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back. The infant's feet will be freed. The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed. The infant's legs will be given in extension position and a clean diaper will be placed under them. Tapes of the clean diaper will be fastened. Hands will be washed after the procedure Data will be collected before, during, after and 3 minutes after application.

Control (Extended leg position) Group

Experimental (Legs are flexed toward abdomen) Group PROCEDURE

Procedure steps for the Experimental Group * Common procedure steps * The infant will be grasped on the legs; the legs will be kept in the flexion position and approached toward the abdomen. * The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back. * The infant's feet will be freed. * The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed and thrown into the medical waste bin. * The infant's legs will be kept in the flexion position and a clean diaper will be placed under them. A bottom care plan will be applied in line with the treatment plan, if necessary. * Tapes of the clean diaper will be fastened. * Hands will be washed after the procedure. * Data will be collected immediately before, during, immediately after and 3 minutes after the end of application.

Experimental (Legs are flexed toward abdomen) Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The preterm infants whose
• Parents have agreed to participate in the study and have signed the informed consent form,
• Who have no congenital anomalies,
• Have no chronic illnesses,
• Have undergone Underwent no surgical procedures,
• Have no neurological symptoms,
• Have not been diagnosed with sepsis,
• Have not been sedated,
• Have not received any pharmacological analgesic method four hours before,
• Have been born between ≥28 and ≤36+6 gestational weeks or have been born earlier and are between ≥28 and ≤36+6 gestational weeks during the application, will be included.

You may not qualify if:

• The preterm infants whose
• Parents have not agreed to participate in the study and have not signed the informed consent form,
• Who have congenital anomalies,
• Have chronic illnesses,
• Have undergone surgical procedures,
• Have neurological symptoms,
• Have been diagnosed with sepsis,
• Have been sedated,
• Have received pharmacological analgesic methods four hours before,
• Were between \<28 and \>36+6 gestational weeks, will be excluded.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, Atasehir, Turkey (Türkiye)

Location

Related Publications (5)

• Lyngstad LT, Tandberg BS, Storm H, Ekeberg BL, Moen A. Does skin-to-skin contact reduce stress during diaper change in preterm infants? Early Hum Dev. 2014 Apr;90(4):169-72. doi: 10.1016/j.earlhumdev.2014.01.011. Epub 2014 Feb 16.

  PMID: 24548816 BACKGROUND

• 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.

  PMID: 16507341 BACKGROUND

• Kolcaba KY. Holistic comfort: operationalizing the construct as a nurse-sensitive outcome. ANS Adv Nurs Sci. 1992 Sep;15(1):1-10. doi: 10.1097/00012272-199209000-00003.

  PMID: 1519906 BACKGROUND

• Grunau RE, Weinberg J, Whitfield MF. Neonatal procedural pain and preterm infant cortisol response to novelty at 8 months. Pediatrics. 2004 Jul;114(1):e77-84. doi: 10.1542/peds.114.1.e77.

  PMID: 15231977 BACKGROUND

• Picheansathian W, Woragidpoonpol P, Baosoung C. Positioning of Preterm Infants for Optimal Physiological Development: a systematic review. JBI Libr Syst Rev. 2009;7(7):224-259. doi: 10.11124/01938924-200907070-00001.

  PMID: 27820087 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases; Premature Birth

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Zehra Kan Öntürk

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 27, 2020
• Study Start: May 17, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)