- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04293913
Use of Illustrated Material in Communication With the Patient in the Mechanical Ventilator
28 febbraio 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
60
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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,
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: gruppo di controllo
nessun intervento
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
change of anxiety over time
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
hemodynamic data
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: bircan kolcak, lecturer, University of Health Sciences, Gulhane Faculty of Nursing, Ankara, Turkey
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 gennaio 2016
Completamento primario (Effettivo)
20 aprile 2017
Completamento dello studio (Effettivo)
15 giugno 2017
Date di iscrizione allo studio
Primo inviato
17 febbraio 2020
Primo inviato che soddisfa i criteri di controllo qualità
28 febbraio 2020
Primo Inserito (Effettivo)
3 marzo 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 febbraio 2020
Ultimo verificato
1 febbraio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 16161616
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
options collected on this subject will be shared in a way that they can be used by other researchers.
Periodo di condivisione IPD
This work is only available after publication
Criteri di accesso alla condivisione IPD
it was approved by the responsible researcher of the study to share this study.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su illustrated communication material
-
Jacobs University Bremen gGmbHGoethe University; University Hospital Ulm; Techniker Krankenkasse; German Coalition... e altri collaboratoriCompletatoCorrelati alla gravidanzaGermania
-
Stanford UniversityBill and Melinda Gates FoundationCompletatoBambino | Gravidanza | Infante | Nutrizione | Salute
-
Instituto de Investigación Sanitaria AragónCompletato
-
Children's Hospital of PhiladelphiaCompletato