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The Effect of Diaper Change Position on Preterm Infants

Primary Purpose

Infant, Premature, Diseases

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Control (Extended leg position) Group

Experimental (Legs are flexed toward abdomen) Group

About this trial

This is an interventional supportive care trial for Infant, Premature, Diseases focused on measuring preterm, diaper change, comfort, position

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Acıbadem University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Control (Extended leg position) Group

Experimental (Legs are flexed toward abdomen) Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Heart rate

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

Change in Respiratory Rate

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

Change in Oxygen Saturation

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04528602

First Posted

August 20, 2020

Last Updated

August 24, 2021

Sponsor

Acibadem University

1. Study Identification

Unique Protocol Identification Number

NCT04528602

Brief Title

The Effect of Diaper Change Position on Preterm Infants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

May 17, 2019 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Premature, Diseases

Keywords

preterm, diaper change, comfort, position

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control (Extended leg position) Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental (Legs are flexed toward abdomen) Group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Control (Extended leg position) Group

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Experimental (Legs are flexed toward abdomen) Group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Heart rate

Description

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

Time Frame

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.

Title

Change in Respiratory Rate

Description

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

Time Frame

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.

Title

Change in Oxygen Saturation

Description

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

Time Frame

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.

Title

Change in Comfort

Description

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zehra Kan Öntürk

Organizational Affiliation

Acibadem University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Acıbadem University

City

Istanbul

State/Province

Atasehir

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24548816

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.

Results Reference

background

PubMed Identifier

16507341

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.

Results Reference

background

PubMed Identifier

1519906

Citation

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.

Results Reference

background

PubMed Identifier

15231977

Citation

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.

Results Reference

background

PubMed Identifier

27820087

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. doi: 10.11124/01938924-200907070-00001.

Results Reference

background

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The Effect of Diaper Change Position on Preterm Infants

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