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

NCT05135429 | Completed

• 1 other identifier: Newborn
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• Pain Score

  Evaluation of the change in the pain status of the newborn according to the initial value with Neonatal Pain Agitation And Sedation Scale (N-PASS) just before the bath, 15, 30 and 60 minutes after the bath. N-PASS, which consists of two separate sections measuring the sedation level and pain level of the baby; It consists of 5 sub-parameters including crying and restlessness, behavior-state, facial expression, hands and feet, body tension and vital signs. A score between 0 and +2 is given for each behavioral and physiological criterion in the evaluation of pain, and between 0 and -2 in the evaluation of sedation. If the baby was born before 30 weeks of gestation, +1 point is added to the total score in the pain assessment. The total pain score ranges from 0 to +11, and the total sedation score ranges from 0 to 10. A high score indicates that the severity of pain is high.

  60 minutes

• sleep time

  Measuring the sleep time of the newborn with a stopwatch evaluation

  two hours

• body temperature

  Evaluation of the change in the temperature of the newborn according to the initial value with a thermometer 15, 30 and 60 minutes after bathing, just before bathing.

  60 minutes

• pulse rate

  Evaluation of the newborn's heart rate 15, 30 and 60 minutes after bathing, with a thermometer just before bathing, according to the baseline value.

  60 minutes

• respiratory rate

  Evaluation of the change in the respiratory rate of the newborn at 15, 30 and 60 minutes after the bath, by observation (during 1 minute) just before the bath, relative to the baseline value.

  60 minutes

• Blood pressure

  Evaluation of the change in blood pressure of the newborn at 15, 30 and 60 minutes after the bath, with a sphygmomanometer just before the bath, according to the baseline value.

  60 minutes

• oxygen saturation

  Evaluation of the change in oxygen saturation of the newborn 15, 30 and 60 minutes after the bath, with a saturation device just before the bath, according to the initial value.

  60 minutes

Study Arms (2)

Bathing group

EXPERIMENTAL

Newborn bathing will be done by the same nurse for each newborn in the study group. Since the evening hours are thought to be calmer for the baby bath, the hours between 22:00-24:00 will be chosen. Each newborn will be disinfected with only water beforehand and showered in the sinks used to wash the baby in the clinic. Bath time will be limited to two minutes. Newborns will be dried and dressed immediately after bathing. Monitor probes for monitor follow-ups and blood pressure cuffs will be connected to prevent extra touching during measurements.

Other: Bathing

control group

NO INTERVENTION

Newborns in the control group will not receive any intervention. However, body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and N-PASS scores will be evaluated and recorded in accordance with the measurement intervals of the newborns in the study group.

Interventions

Bathing OTHER

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

Bathing group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The gestational age of the baby is 34 weeks and above
• Ability to maintain body temperature
• No contraindication for post-surgical bathing
• Not using any analgesic medication
• Body weight of 2000 g and above
• Baby's oxygen need is less than 30%
• No nutritional intolerance
• Parents' willingness to participate in the research

You may not qualify if:

• The gestational age of the premature baby is less than 34 weeks.
• Inability to maintain body temperature
• Contraindication of bathing
• Body weight less than 2000 g
• Oxygen requirement greater than 30%
• Presence of nutritional intolerance
• Contraindication of bathing due to clinical course
• Parents' refusal to participate in the study

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

KaramanogluMehmetbeyU

Karaman, 70100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Baths

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 26, 2021
• Study Start: June 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 4, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

TU (1)