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NCT Number: NCT06836947

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

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Key information

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Katip Çelebi University

Cordaleo, İzmir, 35560, Turkey (Türkiye)

Location status: Recruiting

Location contact

ESRA ARDAHAN AKGÜL

CONTACT

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Respiration

    Time frame: immediately before and immediately after bath

  2. Pulse

    Time frame: immediately before and immediately after bath

  3. Saturation

    Time frame: immediately before and immediately after bath

  4. Mean Blood pressure

    Time frame: immediately before and immediately after bath

  5. Body Temperature

    Time frame: immediately before and immediately after bath

Secondary outcomes

  1. comfort scale point

    Time frame: immediately before and immediately after bath

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ESRA ARDAHAN AKGÜL, Ast. Prof

CONTACT

[email protected]

00902323293535 ext. 4856

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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