The Effect of Diaper Change Position on Preterm Infants

Infant, Premature, Diseases Clinical Trial

Official title:

The Effect of Diaper Change Position on Neonatal Comfort and Heart Rate, Respiratory Rate and Oxygen Saturation in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04528602
• Other study ID #: 2019-5/12
• Status: Completed
• Phase: N/A
• Start date: May 17, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was planned as a randomized controlled prospective trial until reaching the entire sample group specified in the Neonatal Intensive Care Units (NICU) in a private hospital that has other branches in Istanbul.

During the data collection process, two methods will be applied to preterm infants during diaper change.

In the control group of the study, diaper change will be performed after the legs of the babies are brought to extension, and in the experimental group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen by maintaining their flexion. Data on the babies' heart rate, respiratory rate, oxygen saturation and comfort level will be collected using the Premature Infant Comfort Scale before, during, immediately after and 3 minutes after the procedure.

The researchers will collect the data by using a form that questions individual characteristics and includes records of heart rate, respiratory rate and oxygen saturation and Premature Infant Comfort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

Procedure:
• Control (Extended leg position) Group
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.
• Experimental (Legs are flexed toward abdomen) Group
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.

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)

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. — View Citation

Kolcaba KY. Holistic comfort: operationalizing the construct as a nurse-sensitive outcome. ANS Adv Nurs Sci. 1992 Sep;15(1):1-10. Review. — View Citation

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. — View Citation

Mörelius E, Hellström-Westas L, Carlén C, Norman E, Nelson N. Is a nappy change stressful to neonates? Early Hum Dev. 2006 Oct;82(10):669-76. Epub 2006 Feb 28. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.