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Patient CareNCT05310825

An Examination of the Effect on Various Factors of Bed Baths Applied by Two Different Methods in Intensive Care Patients

A study testing Dry Wiping Bath with Single-Use Wipes and Traditional Body Wiping Bath in people with Patient Care, run by Uludag University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patient Care
What is being tested?
Dry Wiping Bath with Single-Use Wipes and Traditional Body Wiping Bath
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 May 2022to 30 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa Uludağ University

    Bursa, Bursa, 16059

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the detailed description

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. The population of the study will consist of patients in the Intensive Care Unit. The size of the study sample was statistically determined with the program G*Power 3.1.7. In the power analysis conducted to determine the sample size, the two bathing methods were compared, and the effect size of blood pressure and breathing rate was determined. For a significance level of 0.05 and 80% power, it was calculated that a total of 22 patients were needed.

Patients with serious burns and/or diarrhea, open wound bandaging or amputations of the upper or lower extremities, those whose blood pressure measurements cannot be taken because of plaster or for other reasons, those who are discharged or die during data collection, and those who do not agree to participate in the study will not be included in the research.

A Patient Description Form and a Patient Bathing Monitoring Form will be used to obtain data.

Patient Description Form: This from will have questions on patients' age, gender, marital status, education level, medical diagnosis, length of time in hospital and in intensive care, chronic illnesses if any are present, method of connection to ventilation, and sedation status.

Patient Bathing Monitoring Form: This form will be used before, during, immediately after and 30 minutes after bathing to record heart rate, blood pressure, body temperature, breathing rate, oxygen saturation values and the time taken for bathing.

Data Collection Intensive care patients will be included in the study who themselves agree to participate, or who are not in a condition to decide, but their legal next of kin voluntarily give their agreement.

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.

Before both of the bed bath procedures, the environment will be adjusted to a temperature of 25°C and 55% airflow. In order to achieve this, there is a room thermometer in intensive care, showing airflow and environment temperature. Screens will be drawn around the patient's bed and the patient's privacy will be respected. The necessary precautions will be taken to ensure that the patient does not fall. Before bathing, the windows and door of the intensive care unit will be closed against any possible draughts in the room. The procedure to be used will be explained to the patients before bathing, using verbal and non-verbal communication techniques. Descriptive information of the patients who agree to participate in the study will be recorded on the Patient Description Form, taken either from themselves or from their files.

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.

Traditional Body Wiping Bath Procedure: 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. As soon as the bathing procedure is commenced, a chronometer will be started by another nurse who is independent of the study.

After the procedure of washing with foam, the patient's whole body will be wiped with rinsing water. After this is completed, the patient's body will be dried with their own personal towel. In wiping each area, a different rubbing cloth will be used. Afterwards, 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.

Dry Wiping Bath with Single-Use Wipes: 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. After heating, the temperature of the cleaning towels will be measured with an infrared thermometer. It is aimed that the temperature should be approximately 43 degrees. 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. Immediately the bathing procedure is commenced, a chronometer will be started by a nurse who is independent of the study.

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.

Conditions
Patient Care
Being tested
Dry Wiping Bath with Single-Use Wipes, Traditional Body Wiping Bath
Keywords
Intensive Care Patients, Bed Baths, nursing, hemodynamic factors, wipe bath

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry Wiping Bath with Single-Use WipesOther

    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.

  • Traditional Body Wiping BathOther

    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

Study groups in NCT05310825
Study groupRoleWhat they receive
Dry Wiping Bath with Single-Use WipesExperimentalCleaning 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.
Receives: Other: Dry Wiping Bath with Single-Use Wipes
Traditional Body Wiping BathOtherBefore 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.
Receives: Other: Traditional Body Wiping Bath

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measure

    heart rate in minute

    Measured: 5 months

Secondary outcomes (1)
  1. Secondary Outcome Measure

    blood pressure in mmHg

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start17 May 2022
  3. Primary completion30 Jun 2022
  4. Study completion30 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
The research is planned as a randomized, controlled, crossover and experimental study
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310825
Sponsor's protocol ID
2022/1-23
Status last verified
Mar 2022
First submitted
1 Mar 2022
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32491124
  • 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.

    PubMed 15149058
  • 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.

    PubMed 33352004
  • Ayhan D, Yilmaz D. Effects of traditional and dry bed baths on patients admitted in intensive units: A randomized crossover clinical trial. Int J Nurs Pract. 2024 Aug;30(4):e13262. doi: 10.1111/ijn.13262. Epub 2024 May 15.

    PubMed 38751063

Questions about this trial

What is this clinical trial studying?

A study testing Dry Wiping Bath with Single-Use Wipes and Traditional Body Wiping Bath in people with Patient Care, run by Uludag University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05310825, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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