- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07635225
Investigating the Effect of Oral Care Frequency on Oral Mucosal Tissue Integrity in Critically Ill Patients. (oral care)
3. juni 2026 opdateret af: berat fidan, Balikesir University
This study aims to investigate the effect of oral care frequency on oral mucosal tissue integrity in intensive care patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Research data will be collected from the Adult Intensive Care Units of Balıkesir University Health Practice and Research Hospital.
Patients meeting the inclusion criteria will be informed about the research, and those who volunteer to participate, or their relatives, will provide written/verbal consent using an Informed Consent Form.
The assignment of patients to different groups will be determined using simple randomization on the randomizer.org
website.
Patients admitted to the intensive care unit at the start of the study will be assigned to control and intervention groups according to the numbers on the randomizer.org
website.
Oral care swabs will be prepared for each patient in both the control and intervention groups, with four swabs per patient, moistened with a 0.25% chlorhexidine gluconate solution.
If the patient is conscious, they will be placed in a comfortable position; if unconscious, their head will be positioned sideways towards the person performing the procedure.
Oral care will be performed on the patient, covering all teeth, inner cheeks, under the tongue, gums, and other soft tissues.
After the patient's oral care procedure is complete, the patient will be returned to their original position, and the procedure will be finished.
Each care session will last at least 2 minutes.
Patients in the control group will receive oral care four times a day, every six hours.
Patients in the intervention group will receive oral care at a frequency determined individually based on their scores on the intensive care oral care frequency assessment scale.
Patients in both groups will be evaluated at the beginning and throughout the intervention using the oral mucosa assessment scale to assess the effect of the oral care on the oral mucosa.
The intervention is planned to continue for five days, and the results will be recorded.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Altıeylül
-
Balıkesir, Altıeylül, Tyrkiet (Türkiye), 10100
- Balıkesir Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
•Patients admitted to the adult intensive care unit:
- Patients aged 18 and over
- Patients who agreed to participate in the study (voluntary informed consent obtained from the patient or their relatives)
- Patients who are not allergic to the contents of the oral care solution to be used were included in the study.
Exclusion Criteria:
• Patients under 18 years of age
- Patients with oral bleeding
- Patients with thrombocytopenia
- Patients who have undergone oral surgery
- Patients who did not consent to the study (either from the patient themselves or a relative) were not included in the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Individualized oral care frequency group
Oral care is provided according to the Intensive Care Oral Care Frequency Assessment Scale score during the follow-up period.
|
Oral care frequency is determined according to the Intensive Care Oral Care Frequency Assessment Scale.
|
|
Aktiv komparator: Routine oral care group
Oral care is provided according to routine unit practice, such as 4 times daily, during the follow-up period.
|
Oral care is provided according to standard intensive care unit routine practice.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intensive Care Unit Oral Care Frequency Assessment Scale (Day 1 to Day 5)
Tidsramme: For 5 days after being admitted to intensive care
|
9 points 12*1 10-19 points 3*1 20-29 points 4*1 30 and above 6*1
|
For 5 days after being admitted to intensive care
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Oral mucosa assessment scale
Tidsramme: 9:00 AM every day for 5 days
|
The scale evaluates five sections of the mouth and its parts (lips, oral mucosa, gingiva, tongue, teeth, and saliva).
Each question is scored from 1 to 4. The lowest possible score is "5" and the highest is "20".
A score of 0-5 indicates normal oral mucosal health, 6-20 indicates mild dysfunction, 11-15 indicates moderate dysfunction, and 16-20 indicates severe dysfunction.
A low score indicates good oral mucosal health, while a high score indicates poor oral mucosal health.
|
9:00 AM every day for 5 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: türkan çalışkan, Balıkesir Üniversitesi Sağlık Bilimleri Fakültesi
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. august 2025
Primær færdiggørelse (Faktiske)
20. oktober 2025
Studieafslutning (Faktiske)
1. februar 2026
Datoer for studieregistrering
Først indsendt
13. april 2026
Først indsendt, der opfyldte QC-kriterier
3. juni 2026
Først opslået (Faktiske)
9. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- E.521870
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
All individual participant data collected, all individual participant data that forms the basis of the results in a publication.
IPD-delingstidsramme
01/05/2026- 01/12/2027
IPD-delingsadgangskriterier
It is accessible to everyone.
They have access to data analysis and work plans.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Patient Care in Intensive Care Units
-
University Hospital, Clermont-FerrandUkendtPatient indlagt på Sygdomsinfektionsenhed | Patient indlagt på Intensiv Reanimation Unit | Patient indlagt på internmedicinsk afdelingFrankrig