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

NCT ID: NCT04293913

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2017-06-15

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.

Conditions

Anxiety; Comfort; Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

illustrated communication material

Intervention Type: 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.

control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role: lead

Responsible Party

Bircan Kolcak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

bircan kolcak, lecturer

Role: PRINCIPAL_INVESTIGATOR

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

References

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.

Reference Type: RESULT

PMID: 25939965 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36827715 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

16161616

Identifier Type: -

Identifier Source: org_study_id