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The Effect of Two Different Bed BathsNCT05762081

The Effect of Two Different Bed Baths Applied to Patients on Mechanical Ventilation Support

A study testing Disposable Wipes for wiping baths and Traditional bed bath in people with The Effect of Two Different Bed Baths and Patients on Mechanical Ventilation Support, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to determine the effect of two different methods (traditional bed bathing and disposable antibacterial wipe bathing) on vital signs in patients on mechanical ventilation support. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Disposable Wipes for wiping baths and Traditional bed bath
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2023to 15 Nov 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older, whose voluntary consent is obtained from a relative or legal guardian,
  • Dependent on mechanical ventilation,
  • Not receiving antihypertensive and sedation therapy,
  • Not taking inotropic drugs that directly affect vital signs (esmolol, noradrenaline dopamine, adrenaline, dopamine nitrate, etc.),
  • No wound that prevents bathing,
  • Moving it does not cause any problems,
  • Minimum 24 hours in intensive care,
  • Patients with blood gas readings taken 30 minutes or more after bathing

Who cannot join

  • Not dependent on mechanical ventilation,
  • Receiving antihypertensive and sedation therapy,
  • Taking inotropic drugs that directly affect vital signs (esmolol, noradrenaline dopamine, adrenaline, dopamine nitrate, etc.),
  • A person with a wound that prevents bathing,
  • It is important to note that moving it does not cause any problems,
  • Less than 24 hours in intensive care,
  • Patients in whom blood gas readings were not taken 30 minutes or more after bathing.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sercan KARA

    Istanbul, 34000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Two Different Bed Baths Applied to Patients on Mechanical Ventilation Support on Vital Signs: A Randomized Controlled Trial

The aim of this study was to determine the effect of two different methods (traditional bed bathing and disposable antibacterial wipe bathing) on vital signs in patients on mechanical ventilation support.

Read the detailed description

The study is planned as a randomized controlled study to determine the effect of the performance of two types of bed (bed-traditional and disposable antibacterial wipe bath) on respiratory parameters and vital signs in adult patients with different clinical conditions connected to mechanical ventilation. At the end of the study, it is aimed to evaluate the effect of traditional and disposable antibacterial wiping baths on vital signs in patients on mechanical ventilation support.

Relatives of the patients who meet the inclusion criteria will be informed about the purpose, content and method of the study and the sample group (experimental and control) will be formed by obtaining written permission from those who voluntarily agree to participate in the study. Determination of the experimental and control groups will be provided by https://www.randomizer.org/ website. The wiping bath protocol with disposable antibacterial wipes will be applied to the experimental group in accordance with the literature, and the traditional bed bath protocol will be applied to the patients in the control group by the researcher himself. Patient Information Form containing information about the demographic characteristics and medical status of the patients included in the study; vital signs (pulse, systolic and diastolic blood pressure, body temperature, respiratory rate and SpO2) and blood gas data will be recorded 3 times in total (before the bath - current blood gas value, immediately after the bath - morning routine blood gas, 30 minutes or more after the bath - the first blood gas taken with the physician's order) based on the values in the routine blood gas measurements of the clinic, partial arterial oxygen and partial arterial carbon dioxide parameters will be recorded in the vital signs follow-up form. All data collection tools will be completed by the researcher himself.

Being tested
Disposable Wipes for wiping baths, Traditional bed bath
Keywords
Nursing, Mechanical Ventilation, Baths, Vital Sings

What participants receive

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

  • Disposable Wipes for wiping bathsProcedure or surgery

    A disposable wipe bath is a type of bath that is applied to bed-bound or unconscious patients and weak individuals by wiping the entire body.

  • Traditional bed bathProcedure or surgery

    Traditional bed bathing is a type of bathing applied to bed-bound or unconscious patients and weak individuals by wiping the entire body with soap and water.

Study groups in NCT05762081
Study groupRoleWhat they receive
Intervention GroupExperimentalIndividuals who have undergone wiping bathing with disposable wipes
Receives: Procedure: Disposable Wipes for wiping baths
Control GroupSham comparatorIndividualswho have undergone bathing with a traditional bath
Receives: Procedure: Traditional bed bath

What is being measured

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

  1. Change in Blood Pressure

    Blood pressure will be measured on the patient monitor. Results will be reported in mmHg.

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  2. Change in Pulse Rate

    Pulse rate will be measured on the patient monitor. The results presented as beat per minute.

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  3. Change in Respiratory Rate

    Respiratory rate will be measured on the patient monitor. Higher scores mean a worse result.

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  4. Change in Body Temperature

    A calibrated non-contact infrared thermometer will be used to measure body temperature. Results will be reported in Celcius.

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  5. Change in Oxygen Saturation

    Oxygen Saturation will be measured on the patient monitor. Approaching %100 is concidered positive. Higher scores mean a better result.

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  6. Change in Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).

    Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  7. Change in Mechanical Ventilation Mode

    The patient's mechanical ventilation mode will be observed. SIMV, CBAP, etc.

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  8. Change in Partial Oxygen Pressure (PaO2)

    The level of partial oxygen pressure is measured as mmHg in arterial blood gase analysis

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

  9. Change in Partial Carbon Dioxide Pressure

    Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)

    Measured: Baseline and immediately after bathing, 30 minutes after bathing

Timeline

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

  1. First posted9 Mar 2023
  2. Study start15 Feb 2023
  3. Primary completion15 Aug 2023 (estimated)
  4. Study completion15 Nov 2023 (estimated)

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
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05762081
Sponsor's protocol ID
2022-282
Status last verified
Feb 2023
First submitted
2 Feb 2023
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aydın, A. (2011). Kişisel Hijyen ve Yatak Yapımı. İçinde T. Aştı ve A. Karadağ (Ed.). Klinik Uygulama Becerileri ve Yöntemleri. Adana: Nobel Tıp Kitabevi; (375-462).

  • Coyer FM, O'Sullivan J, Cadman N. The provision of patient personal hygiene in the intensive care unit: a descriptive exploratory study of bed-bathing practice. Aust Crit Care. 2011 Aug;24(3):198-209. doi: 10.1016/j.aucc.2010.08.001. Epub 2010 Sep 15.

    PubMed 20829060
  • EI-Soussi AH, Asfour Hl.( 2016). Examining bed-bath practices ofcritically ill patients. J Nurs Educ Practice .;( 12):1-11. doi : https: / /doi.org/10 .5430/ jnep.v6n12pl.

  • Garrido D, Assioun JJ, Keshishyan A, Sanchez-Gonzalez MA, Goubran B. Respiratory Rate Variability as a Prognostic Factor in Hospitalized Patients Transferred to the Intensive Care Unit. Cureus. 2018 Jan 23;10(1):e2100. doi: 10.7759/cureus.2100.

    PubMed 29581913
  • Groven FM, Zwakhalen SM, Odekerken-Schroder G, Joosten EJ, Hamers JP. How does washing without water perform compared to the traditional bed bath: a systematic review. BMC Geriatr. 2017 Jan 25;17(1):31. doi: 10.1186/s12877-017-0425-4.

    PubMed 28118815
  • Kızıl, H.(2015). Mekanik Ventilasyonda Olan Entübe Çocuklara Uygulanan Yatak Banyosunun Yaşam Bulgularına Ve Oksijen Satürasyonuna Etkileri. Yüksek Lisans Tezi. Marmara Üniversitesi Sağlık Bilimleri Enstitüsü. İstanbul

  • Moller G, Magalhaes AMM (2015). Bed baths: nursing staff workload and patient safety. Texto Contexto Enferm.;24(4) :1044-52. doi : http ://d x .doi. org/10.1590/ 0104-0707201500003110014.

  • Oz O, Uysal G, Duzkaya DS. Effect of Two Bathing Methods on Physiologic Parameters in Pediatric Intensive Care. Clin Nurs Res. 2022 Jun;31(5):858-865. doi: 10.1177/10547738211043337. Epub 2021 Sep 18.

    PubMed 34538125
  • Paulela DC, Bocchi SC, Mondelli AL, Martin LC, Regina A.(2018) Sobrinho. Effecti veness of bag bath on microbial load: clinical trial. Acta Paul Enferm . ;31(1) :7-16. doi: http://dx.doi.org/10.1590/1982-0194201800003

  • Quiroz S, Castro C, Tirado AF, Rodriguez LM . (2012)Alteraciones hemodinamicas del paciente critico card iovascular durante larealizaci6n del bafio diario. Medicina UPB. https://redib.org/Record/oai_articulo1202311- modelo-de-adaptaci%C3%B3n-de-roy-en-el-ba%C3%B1o-en-cama erişim:04.06.2022

  • Silva LF, Miranda AFA, Silva FVF, Rabelo ACS, Almeida PC, Ponte KMA. (2014) Vital signs and nursing procedures in postoperative period of cardiac surgery. J Nurs UFPE on line.; 8(3):719-25 . doi: 10.5205/reuol.5149-42141-1- SM .0803201429

  • Skewes SM. Skin care rituals that do more harm than good. Am J Nurs. 1996 Oct;96(10):33-5. No abstract available.

    PubMed 8863646
  • Şendir, M., ve Büyükyılmaz, F. (2014). Yoğun Bakım Ünitesinde Çalışan Hemşirelerin İki Farklı Yatak Banyosu Uygulamasına Ilişkin Görüşleri: YarıKalitatif Çalışma ve Maliyet Analizi. 19-22 Kasım 2014 3. Temel Hemşirelik Bakımı Kongresi Bildiri Kitabı, 19-22 Kasım, Antalya.

  • Şendir,M..(2012). Hemşirelik Esasları Uygulama Rehberi. İçinde T. Aştı ve A. Karadağ (Eds.), Kişsel Temizlik ve Giyinme Aktivitesi (2. cilt). İstanbul: İstanbul Kitapevleri ve Yayıncılık;275-279.

  • Tai CH, Hsieh TC, Lee RP. The Effect of Two Bed Bath Practices in Cost and Vital Signs of Critically Ill Patients. Int J Environ Res Public Health. 2021 Jan 19;18(2):816. doi: 10.3390/ijerph18020816.

    PubMed 33477909

Questions about this trial

What is this clinical trial studying?

A study testing Disposable Wipes for wiping baths and Traditional bed bath in people with The Effect of Two Different Bed Baths and Patients on Mechanical Ventilation Support, run by Istanbul University - Cerrahpasa 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Mar 2023. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Change in Blood Pressure (time frame: Baseline and immediately after bathing, 30 minutes after bathing). The study lists 9 primary outcomes in all. 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 NCT05762081, which also lists 20 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 9 Mar 2023.

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