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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

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

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Having undergone cardiac surgery
  2. Being applied mechanical ventilator therapy
  3. Being 18 or over
  4. To have scored minimum 2 to maximum 2 from Richmond Agitation Sedation Scale (RASS)
  5. Agree to participate in the research.

Exclusion Criteria:

  1. not knowing Turkish
  2. Having vision and hearing loss,
  3. 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

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)?

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

3
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