The Effect of Two Different Bathing Methods on Vital Signs and Comfort in PICU:Bath Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-18
SponsorIzmir Katip Celebi University
About this trial
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.
Translated with DeepL.com (free version)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
No contraindications to bathing
Parent's willingness to participate in the study
Disqualifiers
Having a contraindication to bathing
Parents were not willing to participate in the study
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
52 Participants
are grouped into 2 trial groupsGroup A: Traditional Bathing Group
Group B: Wipe Bathing Group
Trial outcomes
Primary outcomes
1
Respiration
Time frame
immediately before and immediately after bath2
Pulse
Time frame
immediately before and immediately after bath3
Saturation
Time frame
immediately before and immediately after bath4
Mean Blood pressure
Time frame
immediately before and immediately after bathSecondary outcomes
1
comfort scale point
The Comfort scale was developed by Ambuel et al (1992). The Comfort scale is a sedation scoring scale that includes two physiological and six behavioural stress criteria. The sick child is assessed on six behavioural (alertness, calm-agitation, respiratory response, physical movement, muscle tone and facial tension) and two physical parameters (blood pressure and heart rate) within two minutes. Each criterion is scored out of five points. Assessment scores: 27-40: Inadequate sedation, 17-26: Appropriate sedation, 8-16: Excessive sedation. Ambuel et al. reported an internal reliability of 0.84 (p\<0.01) for the total score and an internal consistency alpha coefficient of 0.94 for the data collected from 50 observations with 37 patients inthe intensive care unit.
Time frame
immediately before and immediately after bathSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov