AnxietyNCT04293913
Use of Illustrated Material in Communication With the Patient in the Mechanical Ventilator
A study testing illustrated communication material in people with Anxiety and Comfort, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Comfort, Communication
- What is being tested?
- illustrated communication material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
About this study
Official title: The Effect of Using Illustrated Communication Material on Anxiety and Comfort in Communication With Patients Receiving Mechanical Ventilator: Randomised Controlled Clinical Trial
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.
Read the 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
- Being tested
- illustrated communication material
- Keywords
- patient, mechanical ventilator, communication material
- Medical subject headings
- Anxiety Disorders, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
illustrated communication materialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: illustrated communication material |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of anxiety over time
it was measured by using the Faces Anxiety Scale
Measured: 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
Measured: 1 day after surgery
Secondary outcomes (2)
hemodynamic data
hemodynamic data are systolic and diastolic blood pressure, heart rate, respiration rate, and peripheral oxygen
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start15 Jan 2016
- Primary completion20 Apr 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bircan Kolcak, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- bircan kolcak, lecturer, Principal investigator, University of Health Sciences, Gulhane Faculty of Nursing, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293913
- Sponsor's protocol ID
- 16161616
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: options collected on this subject will be shared in a way that they can be used by other researchers.
Publications
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.
PubMed 25939965Kolcak 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.
PubMed 36827715
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Illustrated Communication Material on Anxiety and Comfort in Communication With Patients Receiving Mechanical Ventilator: Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04293913
- Acronym / sponsor ID
- 16161616
- Conditions
- Anxiety, Comfort, Communication
- Keywords
- patient, mechanical ventilator, communication material
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: illustrated communication materialIn 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. |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| illustrated communication materialIllustrated 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. | Behavioural | intervention group |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Results publication: PubMed 25939965Wang 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.
- Derived from this study: PubMed 36827715Kolcak 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.
- Individual participant dataSharing planned: Yes. options collected on this subject will be shared in a way that they can be used by other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bircan kolcak, lecturer principal investigator
University of Health Sciences, Gulhane Faculty of Nursing, Ankara, Turkey
Questions about this trial
What is this clinical trial studying?
A study testing illustrated communication material in people with Anxiety and Comfort, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.