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Completed

NCT Number: NCT06166485

The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies

In this study, the bath applied to term babies in two different orders (first washing the body and lastly the head, and the classical method in which the whole body is washed starting from the head first), the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (time of bathing). ) was planned to determine its effect on the calming time of babies.

The effects of two different bathing methods given to healthy and term babies on the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (bathing time), and calming time of the babies will be compared.

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Key information

Conditions

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpaşa

Istanbul, 34, Turkey (Türkiye)

About this study

The researcher will briefly talk about the scope and content of the research by meeting with the parents of babies who meet the selection criteria to apply the first bath of term and healthy babies before discharge, at the earliest 6 hours after birth.

Healthy, term newborns will be divided into two groups, one group will be washed from body to head, and the other group will be washed from head to body, which is the traditional method. In the study, the stress levels of babies will be obtained by observing the newborns independently by two different observer nurses before, after and after the procedure, using the "Newborn Stress Scale", at the 5th, 15th and 30th minutes. Physiological parameters of the babies will be evaluated before the procedure, during the procedure, and at the 1st, 5th and 15th minutes after the procedure. Bathing will be done by the same person (researcher) for all babies in both the experimental and control groups.

Pulse oximeter and stopwatch will be used to measure physiological parameters (heart rate, oxygen saturation, calming time).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The baby's body weight is between 2.5 - 4 kg
  • The baby's Apgar score is >7
  • The baby does not have any health problems
  • Their parents agree to participate in the study
  • Having a healthy term baby.

Exclusion criteria

  • Meconium aspiration etc. washed immediately after birth for various reasons,
  • Having various health problems,
  • Their parents did not agree to participate in the study,
  • Low birth weight and premature babies

Treatment and study plan

take a bath

Other

The effects of two different bathtub bath methods on physiological parameters will be compared in babies divided into 2 different groups.

Primary outcomes

  1. Newborn stress scale

    Time frame: This scale evaluation will be applied to healthy, term babies who are hospitalized in the neonatal clinic within a 3-month period and the study will be conducted.

    This scale can evaluate the stress level in newborns.Scale items are grouped into 8 subgroups.These subgroups consist of a total of 24 items in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture.In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.

  2. Data collection form

    Time frame: The 36-question data collection form will be applied to the mother of the baby on whom the study will be conducted and to the observers making the evaluation within 3 months of data collection.

    The form consists of 4 sections and 36 questions in total. The first part of the form is a 7-question form to collect demographic and obstetric information of mothers who agreed to participate in the study. The second part is a 9-question form in which information about the baby to be included in the study is collected. In the third section, it is a form with 15 questions in which information about the application is collected. In the fourth section, it is a form with 5 questions in which information regarding the evaluation of the baby with the stress scale is collected.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2023
Registry last updated
Jan 3, 2024

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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