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

NCT ID: NCT06836947

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-09

Study Completion Date

2025-05-30

Brief Summary

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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

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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

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Vital Sign Monitoring Comfort

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Traditional Bathing Group

In traditional bathing, the patient is also bathed in bed with 36-37 degrees water.

No interventions assigned to this group

Wipe Bathing Group

Wipe bathing is performed with 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

28 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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ESRA ARDAHAN AKGUL

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Katip Çelebi University

Cordaleo, İzmir, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ESRA ARDAHAN AKGÜL, Ast. Prof

Role: CONTACT

00902323293535 ext. 4856

Facility Contacts

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ESRA ARDAHAN AKGÜL

Role: primary

Other Identifiers

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ikçü

Identifier Type: OTHER

Identifier Source: secondary_id

006

Identifier Type: -

Identifier Source: org_study_id

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