Clinical trial NCT06836947: The Effect of Two Different Bathing Methods on Vital Signs and Comfort in PICU:Bath Trial
Official title: The Effect of Two Different Bathing Methods on Vital Signs and Comfort in Pediatric Intensive Care Unit:Bath Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vital Sign Monitoring
Comfort
Keywords: pediatrics
bath
nursing care
vital signs
comfort
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 52
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: G\*power 3.1.9.7 program was used to calculate the sample size required for the study and it was found that a total of 52 patients, 26 patients in each group, should be reached with an effect size of 0.96 (Öz, 2022), power of 0.95 (1-ß) and α:0.05.

Brief summary: The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The study is a prospective, quasi-experimental study.

The population of the study will consist of children who are hospitalized in the Pediatric Intensive Care Unit of SBÜ. İzmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. The vital signs and comfort of the children of the parents who agreed to participate in the study will be measured before bathing (baseline) and care will be taken to ensure that they are similar in both groups.

Children in the study will not be randomized. In the routine operation of the clinic, traditional bathing is performed once a week and wipe bathing is performed once every two days. Wipe bathing is performed at 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. Traditional bathing is also performed with 36-37 degrees water in bed or in the bathtub. In the study, no intervention will be performed and the outcomes will be measured and compared with each other before and after both bathing procedures.

Physiologic parameters including respiratory rate, pulse rate, oxygen saturation and comfort levels of newborns just before, during and after the bathing process (1st and 5th minute) will be evaluated and compared with each other. To avoid bias in the study, all bathing procedures will be performed by Specialist Nurse Esat Erdem GÖKPINAR.

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Detailed description: The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The study is a prospective, quasi-experimental study.

The population of the study will consist of children who are hospitalized in the Pediatric Intensive Care Unit of SBÜ. İzmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. The vital signs and comfort of the children of the parents who agreed to participate in the study will be measured before bathing (baseline) and care will be taken to ensure that they are similar in both groups.

Children in the study will not be randomized. In the routine operation of the clinic, traditional bathing is performed once a week and wipe bathing is performed once every two days. Wipe bathing is performed at 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. Traditional bathing is also performed with 36-37 degrees water in bed or in the bathtub. In the study, no intervention will be performed and the outcomes will be measured and compared with each other before and after both bathing procedures.

Physiologic parameters including respiratory rate, pulse rate, oxygen saturation and comfort levels of newborns just before, during and after the bathing process (1st and 5th minute) will be evaluated and compared with each other. To avoid bias in the study, all bathing procedures will be performed by Specialist Nurse Esat Erdem GÖKPINAR.

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Eligibility criteria: Inclusion Criteria:

1. Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
2. No contraindications to bathing
3. Parent's willingness to participate in the study

Exclusion Criteria:

1. Having a contraindication to bathing
2. Parents were not willing to participate in the study

Primary outcomes:
measure: Respiration
timeFrame: immediately before and immediately after bath
measure: Pulse
timeFrame: immediately before and immediately after bath
measure: Saturation
timeFrame: immediately before and immediately after bath
measure: Mean Blood pressure
timeFrame: immediately before and immediately after bath
measure: Body Temperature
timeFrame: immediately before and immediately after bath
Secondary outcomes:
measure: comfort scale point
timeFrame: immediately before and immediately after bath
Other outcomes:
Locations:
city: Karşıyaka
country: Turkey
facility: Katip Çelebi University
state: İzmir
Study officials:
References: