The Effect of Two Different Bathing Methods on Vital Signs and Comfort in PICU:Bath Trial

The Effect of Two Different Bathing Methods on Vital Signs and Comfort in Pediatric Intensive Care Unit:Bath 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.

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Study Overview

• Status: Recruiting
• Conditions: Comfort; Vital Sign Monitoring

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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• Study Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

• Study Contact: Name: ESRA ARDAHAN AKGÜL, Ast. Prof; Phone Number: 4856 00902323293535; Email: esraardahan90@gmail.com

Study Locations

• Turkey
  • İzmir
    • Karşıyaka, İzmir, Turkey, 35560
      • Recruiting
      • Katip Celebi University
      • Contact: ESRA ARDAHAN AKGÜL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Traditional Bathing Group; In traditional bathing, the patient is also bathed in bed with 36-37 degrees water.
Wipe Bathing Group; Wipe bathing is performed with 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiration	immediately before and immediately after bath
Pulse	immediately before and immediately after bath
Saturation	immediately before and immediately after bath
Mean Blood pressure	immediately before and immediately after bath
Body Temperature	immediately before and immediately after bath

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	immediately before and immediately after bath

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Actual): May 1, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pediatrics; comfort; vital signs; nursing care; bath
• Other Study ID Numbers: 006; ikçü (Other Identifier: Katip Çelebi University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: By ethical rules, patient information will only be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No