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Use of Illustrated Material in Communication With the Patient in the Mechanical Ventilator

Primary Purpose

Anxiety, Comfort, Communication

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
illustrated communication material
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring patient, mechanical ventilator, communication material

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    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.

    no intervention

    Outcomes

    Primary Outcome Measures

    change of anxiety over time
    it was measured by using the Faces Anxiety Scale
    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

    Secondary Outcome Measures

    hemodynamic data
    hemodynamic data are systolic and diastolic blood pressure, heart rate, respiration rate, and peripheral oxygen
    communication satisfaction and adequacy of communication techniqu, change of pain over time
    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

    Full Information

    First Posted
    February 17, 2020
    Last Updated
    February 28, 2020
    Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04293913
    Brief Title
    Use of Illustrated Material in Communication With the Patient in the Mechanical Ventilator
    Official Title
    The Effect of Using Illustrated Communication Material on Anxiety and Comfort in Communication With Patients Receiving Mechanical Ventilator: Randomised Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2016 (Actual)
    Primary Completion Date
    April 20, 2017 (Actual)
    Study Completion Date
    June 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Comfort, Communication
    Keywords
    patient, mechanical ventilator, communication material

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    no intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    illustrated communication material
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    change of anxiety over time
    Description
    it was measured by using the Faces Anxiety Scale
    Time Frame
    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
    Title
    comfort level
    Description
    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
    Time Frame
    1 day after surgery
    Secondary Outcome Measure Information:
    Title
    hemodynamic data
    Description
    hemodynamic data are systolic and diastolic blood pressure, heart rate, respiration rate, and peripheral oxygen
    Time Frame
    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
    Title
    communication satisfaction and adequacy of communication techniqu, change of pain over time
    Description
    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
    Time Frame
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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,
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    bircan kolcak, lecturer
    Organizational Affiliation
    University of Health Sciences, Gulhane Faculty of Nursing, Ankara, Turkey
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    options collected on this subject will be shared in a way that they can be used by other researchers.
    IPD Sharing Time Frame
    This work is only available after publication
    IPD Sharing Access Criteria
    it was approved by the responsible researcher of the study to share this study.
    Citations:
    PubMed Identifier
    25939965
    Citation
    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.
    Results Reference
    result

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    Use of Illustrated Material in Communication With the Patient in the Mechanical Ventilator

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