- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04293913
Use of Illustrated Material in Communication With the Patient in the Mechanical Ventilator
28 februari 2020 uppdaterad av: Bircan Kolcak, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
The Effect of Using Illustrated Communication Material on Anxiety and Comfort in Communication With Patients Receiving Mechanical Ventilator: Randomised Controlled Clinical Trial
This study was carried out to determine the effect of the use of communication material on the anxiety and comfort of the patient in communication with patients receiving mechanical ventilators.As a result, the use of communication material reduces anxiety and increases patient satisfaction and comfort level.
In communicating with intubated patients receiving mechanical ventilator therapy, the use of illustrated communication material is recommended.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The use ofcommunication material in communication with patients receiving mechanical ventilator support increases patient satisfaction and reduces communication difficulties.
However, there was no randomized controlled clinical study showing the effect of the use of these materials on patient care outcomes such as anxiety and comfort level.Patients were randomly assigned to the control groups using illustrated communication material and intervention and routine communication methods.
The research was carried out in three stages: preoperative, intensive care and one day after surgery.
The primary outcomes of the study were pain, anxiety and comfort levels of the patients.
Secondary outcomes were the patients' satisfaction with hemodynamic parameters and communication method.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Having undergone cardiac surgery
- Being applied mechanical ventilator therapy
- Being 18 or over
- To have scored minimum 2 to maximum 2 from Richmond Agitation Sedation Scale (RASS)
- Agree to participate in the research.
Exclusion Criteria:
- not knowing Turkish
- Having vision and hearing loss,
- Having a cognitive or psychological problem that prevents them from communicating. 4. Having an intubation experience before
5. Bleeding, etc. in the early postoperative period. industrial development such as undergoing revision surgery or needing additional sedation,
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: kontrollgrupp
inget ingripande
|
|
Experimentell: intervention group
In the intervention group, communication was established with the illustrated communication material.
The pain, anxiety scores, and hemodynamic data of the patients were recorded by the intensive care nurse in three consecutive measurements starting with the first communication (0th minute) and at 30th and 60th minutes.
On the first postoperative day, the satisfaction of the communication established with them, as well as their evaluations regarding the adequacy of this communication and their comfort levels were determined during the time they received mechanical ventilation therapy.
|
Illustrated communication material was introduced to the patients in the intervention group.
In the process (intensive care) that patients received mechanical ventilation support after the operation, agitation and sedation levels were monitored by the intensive care nurse who was to communicate with the patient using the Richmond Agitation Sedation Scale (RASS).
According to this scale, having minimum -2 and maximum +2 points was accepted as the starting criteria for communication (Sessler et al., 2002).
Communication was established with the illustrated communication material.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
change of anxiety over time
Tidsram: The anxiety scores were recorded by the intensive care nurse in three consecutive measurements starting with the first communication (0th minute) and at 30th and 60th minutes
|
it was measured by using the Faces Anxiety Scale
|
The anxiety scores were recorded by the intensive care nurse in three consecutive measurements starting with the first communication (0th minute) and at 30th and 60th minutes
|
comfort level
Tidsram: 1 day after surgery
|
Postoperative comfort levels of the patients were determined by the Early Postoperative Comfort Scale.The highest total score that can be obtained from the scale is 144, and the lowest total score is 24.
High scores show that comfort is good, and low scores show that comfort is depraved
|
1 day after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
hemodynamic data
Tidsram: Hemodynamic data were recorded through the patient monitor by intensive care nurses in three consecutive measurements starting with the first communication (0th minute) and at 30th and 60th minutes
|
hemodynamic data are systolic and diastolic blood pressure, heart rate, respiration rate, and peripheral oxygen
|
Hemodynamic data were recorded through the patient monitor by intensive care nurses in three consecutive measurements starting with the first communication (0th minute) and at 30th and 60th minutes
|
communication satisfaction and adequacy of communication techniqu, change of pain over time
Tidsram: Pain data were recorded as 30th and 60th minutes, starting from the first communication (0th minute) in mechanical ventilation. Satisfaction and adequacy of communication were evaluated an average of 24 hours after surgery
|
It is stated that numerical scales have been adopted more in clinical practice because they are useful in facilitating the definition of pain intensity, facilitating scoring and recording, and evaluating ceiling and floor effects.
"The Numerical Evaluation Scale" was used to determine the pain levels of patients and to evaluate their satisfaction with the communication method used and the adequacy of the method
|
Pain data were recorded as 30th and 60th minutes, starting from the first communication (0th minute) in mechanical ventilation. Satisfaction and adequacy of communication were evaluated an average of 24 hours after surgery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: bircan kolcak, lecturer, University of Health Sciences, Gulhane Faculty of Nursing, Ankara, Turkey
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 januari 2016
Primärt slutförande (Faktisk)
20 april 2017
Avslutad studie (Faktisk)
15 juni 2017
Studieregistreringsdatum
Först inskickad
17 februari 2020
Först inskickad som uppfyllde QC-kriterierna
28 februari 2020
Första postat (Faktisk)
3 mars 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 mars 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16161616
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
options collected on this subject will be shared in a way that they can be used by other researchers.
Tidsram för IPD-delning
This work is only available after publication
Kriterier för IPD Sharing Access
it was approved by the responsible researcher of the study to share this study.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Ångest
-
Szeged UniversityAvslutadCoping färdigheter | Humör | Covid-19 pandemi | Psykologisk stress | Subjektivt hälsoklagomål | Frågeformulärdesigner | Tvådelad skala för generaliserat ångestsyndrom | Patienthälsa frågeformulär Anxiety and Depression Scale | HälsostatusindexUngern
Kliniska prövningar på illustrated communication material
-
Northwestern UniversityNational Institute on Aging (NIA)AvslutadDemens | Kommunikation | Alzheimers sjukdom | Primär progressiv afasi | AfasiFörenta staterna
-
Jacobs University Bremen gGmbHGoethe University; University Hospital Ulm; Techniker Krankenkasse; German... och andra samarbetspartnersAvslutadGraviditetsrelateradTyskland
-
Northwestern UniversityNational Institute on Aging (NIA)AvslutadPrimär progressiv afasiFörenta staterna
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RekryteringPosttraumatisk stressyndrom | Hospitalism hos barnFörenta staterna
-
University of ChicagoNational Institute on Aging (NIA); Western University, CanadaHar inte rekryterat ännu
-
Jordan University of Science and TechnologyAvslutadAutismspektrumstörningJordanien
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)RekryteringFörsta episod psykos (FEP) | Klinisk högrisk för psykos (CHR)Förenta staterna
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)AvslutadLungsjukdomar | AstmaFörenta staterna
-
University of British ColumbiaChild and Family Research InstituteAvslutad
-
Stanford UniversityBill and Melinda Gates FoundationAvslutadBarn | Graviditet | Spädbarn | Näring | Hälsa