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Completed

NCT Number: NCT04528602

The Effect of Diaper Change Position on Preterm Infants

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases 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, Atasehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Heart rate

    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.

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

  2. Change in Respiratory Rate

    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.

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

  3. Change in Oxygen Saturation

    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.

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

  4. Change in Comfort

    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.

    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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Aug 25, 2021

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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