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Effect of Bathing on Pain, Sleep and Vital Signs of Premature Babies

NCT05135429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-11-26

No results posted yet for this study

Summary

This study was conducted as a randomized controlled experimental study to determine the effect of bathing given to premature babies on pain, sleep and vital signs. The data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized in Selcuk University Hospital Neonatal Intensive Care Unit between 1 June and 31 August 2020. The sample size was determined as 64 premature newborns. "Interview and Observation Form, Neonatal Pain/Agitation, Sedation Scale" was used for data collection. The data were evaluated with the SPSS 21.0 package program using percentage, mean, standard deviation, chi-square, t test, Anova and Tukey advanced analysis test.

The research was carried out in the following order. All permissions were obtained for data collection. Individual characteristics were obtained from family members and recorded in the questionnaire. Before the procedure, the pain levels of the newborns were evaluated and recorded. The status of babies in the study or control group was randomly determined according to the hospitalization day (www.randomizer.com).

The newborns in the study group were given a baby bath. The baby's body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand, and N-PASS scores were evaluated and recorded by two observers before the bath, at the 15th, 30th and 60th minutes after the bath.

No intervention was given to the newborns in the control group. However, body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and N-PASS scores were evaluated and recorded in accordance with the measurement intervals of the newborns in the study group.

Cohen's kappa analysis was performed to assess interobserver agreement. Since the inter-observer agreement was found to be excellent (k=0.85), analysis was performed with an observer evaluation.

All newborns were measured at the same time of the day.

Conditions

  • Preterm

Interventions

OTHER

Bathing

The data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized.

Sponsors & Collaborators

  • Karamanoğlu Mehmetbey University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-08-31
Completion
2021-09-04

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135429 on ClinicalTrials.gov