NCT04293913

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

February 17, 2020

Last Update Submit

February 28, 2020

Conditions

Keywords

patientmechanical ventilatorcommunication material

Outcome Measures

Primary Outcomes (2)

  • change of anxiety over time

    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

    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

Secondary Outcomes (2)

  • hemodynamic data

    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

    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

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Behavioral: illustrated communication material

control group

NO INTERVENTION

no intervention

Interventions

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.

intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • \. Bleeding, etc. in the early postoperative period. industrial development such as undergoing revision surgery or needing additional sedation,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wang Y, Li H, Zou H, Li Y. Analysis of Complaints from Patients During Mechanical Ventilation After Cardiac Surgery: A Retrospective Study. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):990-4. doi: 10.1053/j.jvca.2015.01.036. Epub 2015 Jan 29.

  • Kolcak B, Ayhan H, Tastan S. The effect of using illustrated materials for communication on the anxiety and comfort of cardiac surgery patients receiving mechanical ventilator support: A randomized controlled trial. Heart Lung. 2023 May-Jun;59:157-164. doi: 10.1016/j.hrtlng.2023.02.005. Epub 2023 Feb 22.

MeSH Terms

Conditions

Anxiety DisordersCommunication

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • bircan kolcak, lecturer

    University of Health Sciences, Gulhane Faculty of Nursing, Ankara, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was planned as a randomized controlled clinical trial with two arms: Patients who had undergone cardiac surgery were randomly assigned to intervention (illustrated communication material were used) and control (routine methods in the communication were used) groups when they were connected to the mechanical ventilator.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2020

First Posted

March 3, 2020

Study Start

January 15, 2016

Primary Completion

April 20, 2017

Study Completion

June 15, 2017

Last Updated

March 3, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

options collected on this subject will be shared in a way that they can be used by other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
This work is only available after publication
Access Criteria
it was approved by the responsible researcher of the study to share this study.