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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293913
• Other study ID #: 16161616
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: June 15, 2017

Study information

• Verified date: February 2020
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Comfort
• Communication

Intervention

Behavioral:
• illustrated communication material
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	hemodynamic data	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
Secondary	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	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