NCT05310825

Brief Summary

The aim of this study is to evaluate the effect on various hemodynamic factors (breathing, pulse, blood pressure, peripheral oxygen saturation) of patients in intensive care units and the time taken for the procedure of a traditional wiping bed bath performed with soap and water) and one performed with single-use wipes. The research is planned as a randomized, controlled, crossover and experimental study. Because it is planned as a crossover study, patients will be in both the experimental and the control group. The research will be conducted in the General Surgery Intensive Care Unit of Bursa Uludağ University Health Applications Research Center, Turkey. The population of the study will consist of patients in the Intensive Care Unit. Patients participating in the study will be given two types of wiping body bath. One of these will be a wiping body bath performed with soap and water, which is accepted as a traditional bed bath. The other will be a body wiping bath performed with single-use wipes, which is accepted as a dry bath. All bathing procedures in the study will be conducted by the same researcher. During both types of bathing, an assistant patient care worker will help the researcher in the process of turning the patient. Before starting, this assistant will be given information on the steps in bed bathing by the researcher. Each patient will be given a traditional wiping bed bath and a dry wiping bath with single-use wipes. Because this is a crossover study, the patient will be part of both the experimental and the control group. The patient's first bath will be within the first 24 hours of entry to the intensive care unit. The randomization of each patient's bathing will be carried out according to a randomization list created on a computer and the patients will be assigned to the study groups by the randomization method. In this way, patients will be assigned to group 1 (traditional body wipe bathing with soap and water) and group 2 (dry body wipe bathing with single-use wipes). The bathing order will be carried out according to the randomization for each patient, and in this way, the patient's first bath will be performed as dry body wipe bathing with single-use wipes or as traditional body wipe bathing with soap and water. For each bath, a minimum interval of 24 hours (washing) will be left to prevent one intervention from affecting the other. Immediately before giving each type of bed bath, every five minutes during the bathing procedure, immediately after finishing the bathing procedure and 30 minutes after finishing the bathing procedure, the patient's pulse, blood pressure, body temperature, breathing rate and oxygen saturation will be measured by a different nurse, and the values obtained together with the time taken for the procedure will be entered on the Patient Bathing Monitoring Form. The steps to be followed in the wiping procedures of both baths will be, in order, cleaning the patient's face area (the eyes will only be cleaned with rinsing water), the ears on each side, the arms, the hands, the breast and chest area, the legs on each side, the feet, the back, and finally, the perineum and anal area, after which the washing procedure will be terminated. After bathing, the patient's bedsheets and clothing will be changed and waste will be removed from the area. If the bandaging in the patient's operation area has not yet been removed, the operation area will not be washed. Also, the chronometer will be stopped by a nurse who is independent of the study immediately after the bathing procedure is completed, and the time taken for the procedure will be entered on the form.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

March 1, 2022

Last Update Submit

March 26, 2025

Conditions

Keywords

Intensive Care PatientsBed Bathsnursinghemodynamic factorswipe bath

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    heart rate in minute

    5 months

Secondary Outcomes (1)

  • Secondary Outcome Measure

    5 months

Other Outcomes (7)

  • Third Outcome Measure

    5 months

  • Fourth Outcome Measure

    5 months

  • Fifth Outcome Measure

    5 months

  • +4 more other outcomes

Study Arms (2)

Dry Wiping Bath with Single-Use Wipes

EXPERIMENTAL

Cleaning wipes will be used in the bathing process which do not contain alcohol, paraben or latex. Before taking them out of the packet, the wipes to be used in the bathing will be heated according to usage instructions at 850 W for 50 seconds in a microwave oven which will be brought by the researcher. After heating, the temperature of the cleaning towels will be measured with an infrared thermometer. The reason for heating the wipes is to bring them to the same temperature as the bath water and thus to prevent any factors arising from a temperature difference.

Other: Dry Wiping Bath with Single-Use Wipes

Traditional Body Wiping Bath

OTHER

Before bathing, two basins will be filled with a suitable amount (2/3 of the basin) of water at a suitable temperature (43°C). Water temperature will be measured by the researcher with a water thermometer. This thermometer will be used to bring the bath water to the correct temperature. Neutral soap will be added to the water of one basin, while the water of the other basin will be used for rinsing. The neutral soap to be used will not dry the skin or cause chafing or irritation, and it will be noon-allergenic. At the same time, soap with these characteristics is one which is routinely used for patient hygiene in the intensive care unit where the study will be conducted. The rubbing cloth to be used with both the soapy and the rinsing water in the routine procedure will have an inner layer of pure cotton with an outer layer of hydrophilic gauze. The patient's body wash will be performed with this cloth, using foam from the soapy water.

Other: Traditional Body Wiping Bath

Interventions

Cleaning wipes will be used in the bathing process which do not contain alcohol, paraben or latex. These wipes are a product routinely used in patient hygiene procedures in the intensive care unit where the study is to be conducted. Before taking them out of the packet, the wipes to be used in the bathing will be heated according to usage instructions at 850W for 50 seconds in a microwave oven which will be brought by the researcher The steps to be followed in the wiping procedures of bath will be, in order, cleaning the patient's face area (the eyes will only be cleaned with rinsing water), the ears on each side, the arms, the hands, the breast and chest area, the legs on each side, the feet, the back, and finally, the perineum and anal area, after which the washing procedure will be terminated.

Dry Wiping Bath with Single-Use Wipes

The rubbing cloth to be used with both the soapy and the rinsing water in the routine procedure will have an inner layer of pure cotton with an outer layer of hydrophilic gauze. The patient's body wash will be performed with this cloth, using foam from the soapy water. As soon as the bathing procedure is commenced, a chronometer will be started by another nurse who is independent of the study. The steps to be followed in the wiping procedures of bath will be, in order, cleaning the patient's face area (the eyes will only be cleaned with rinsing water), the ears on each side, the arms, the hands, the breast and chest area, the legs on each side, the feet, the back, and finally, the perineum and anal area, after which the washing procedure will be terminated

Traditional Body Wiping Bath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and over,
  • Having upper and lower extremities,
  • Good capillary filling,
  • Systolic blood pressure is between 90-150 mmHg,
  • SaO2 value of 90% and above,
  • Willing to participate in the research

You may not qualify if:

  • Serious burns and/or diarrhea
  • Open wound bandaging or amputations of the upper or lower extremities
  • Discharged or die during data collection
  • Do not agree to participate in the study will not be included in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludağ University

Bursa, Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (3)

  • Toledo LV, Salgado PO, Souza CC, Brinati LM, Januario CF, Ercole FF. Effects of dry and traditional bed bathing on respiratory parameters: a randomized pilot study. Rev Lat Am Enfermagem. 2020;28:e3264. doi: 10.1590/1518-8345.3668.3264. Epub 2020 Jun 1.

    PMID: 32491124BACKGROUND
  • Larson EL, Ciliberti T, Chantler C, Abraham J, Lazaro EM, Venturanza M, Pancholi P. Comparison of traditional and disposable bed baths in critically ill patients. Am J Crit Care. 2004 May;13(3):235-41.

    PMID: 15149058BACKGROUND
  • Groven FMV, Zwakhalen SMG, Odekerken-Schroder G, Tan F, Hamers JPH. Comfort during the bed bath-A randomised crossover trial on the effect of washing without water versus water and soap in nursing students. J Clin Nurs. 2021 Aug;30(15-16):2234-2245. doi: 10.1111/jocn.15610. Epub 2021 May 6.

    PMID: 33352004BACKGROUND

Study Officials

  • Şenay Yiğit Avcı, MSc

    General Surgery Intensive Care Unit of Bursa Uludağ University Health Applications Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The intervention and measurements were carried out by the first researcher.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The research is planned as a randomized, controlled, crossover and experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bursa Uludag University, Department of Nursing

Study Record Dates

First Submitted

March 1, 2022

First Posted

April 5, 2022

Study Start

May 17, 2022

Primary Completion

June 30, 2022

Study Completion

August 30, 2022

Last Updated

April 1, 2025

Record last verified: 2022-03

Locations