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

NCT06836947 | Recruiting

• 2 other identifiers: 006ikçü
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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. Translated with DeepL.com (free version)

Conditions

Vital Sign Monitoring; Comfort

Keywords

pediatrics; bath; nursing care; vital signs; comfort

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• comfort scale point

  immediately before and immediately after bath

Study Arms (2)

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.

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Having a contraindication to bathing
• Parents were not willing to participate in the study

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Katip Çelebi University

Cordaleo, İzmir, 35560, Turkey (Türkiye)

RECRUITING

Central Study Contacts

ESRA ARDAHAN AKGÜL, Ast. Prof

CONTACT

00902323293535; esraardahan90@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: April 9, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 30, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

TU (1)