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Completed

NCT Number: NCT04293913

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Comfort Communication Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

illustrated communication material

Behavioral

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 outcomes

  1. change of anxiety over time

    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

    it was measured by using the Faces Anxiety Scale

  2. comfort level

    Time frame: 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

Secondary outcomes

  1. hemodynamic data

    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

    hemodynamic data are systolic and diastolic blood pressure, heart rate, respiration rate, and peripheral oxygen

  2. communication satisfaction and adequacy of communication techniqu, change of pain over time

    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

    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

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Registry information

Official study title

The Effect of Using Illustrated Communication Material on Anxiety and Comfort in Communication With Patients Receiving Mechanical Ventilator: Randomised Controlled Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2020
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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