- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05255887
The Effect of Informing Patients With Video Surgery
August 27, 2023 updated by: Figen Dıgın, Kırklareli University
The Effect of Informing Patients With Video on Intensive Care Experiences Before Heart Surgery
Purpose of the research; The aim of this study is to determine the effect of informing patients with video before heart surgery on their intensive care experience."Patient
Descriptive Information Form" and "Intensive Care Experience Scale (ICES)" will be used to collect data.In Kavuncu's study, the average score they got from ICES was found to be 57.07±5.6.
It was calculated that 45 patients from each group should be included in the study in order to test the 0.6-unit effect size value, which was calculated by accepting a 5% difference from this score in the experimental group, with a 5% margin of error, 95% confidence level and 80% power value.In the study, after the patients admitted to the cardiovascular surgery service for cardiac surgery were informed about the purpose and importance of the study and the research, informed consent will be obtained verbally and in writing from the volunteer patients.
In order to ensure randomization of the patients in the study, a randomization plan was prepared for 45 experiments and 45 controls using a probabilistic scheme-based computer program.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Purpose of the research; The aim of this study is to determine the effect of informing patients with video before heart surgery on their intensive care experience."Patient
Descriptive Information Form" and "Intensive Care Experience Scale (ICES)" will be used to collect data.In Kavuncu's study, the average score they got from ICES was found to be 57.07±5.6.
It was calculated that 45 patients from each group should be included in the study in order to test the 0.6-unit effect size value, which was calculated by accepting a 5% difference from this score in the experimental group, with a 5% margin of error, 95% confidence level and 80% power value.In the study, after the patients admitted to the cardiovascular surgery service for cardiac surgery were informed about the purpose and importance of the study and the research, informed consent will be obtained verbally and in writing from the volunteer patients.
In order to ensure randomization of the patients in the study, a randomization plan was prepared for 45 experiments and 45 controls using a probabilistic scheme-based computer program.
24-48 hours before the surgery, the patients will be shown an informative video about the intensive care environment in a separate room through a one-on-one interview.
In the study, no attempt will be made to the control group patients other than the routine practice of the institution before the surgery.
In the study, the day of discharge from the intensive care unit will be counted as the first day, and on the second day, the 'Intensive Care Experience Scale' will be applied to the patients in both the experimental and control groups by face-to-face interview method.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kırklareli, Turkey, 39100
- Kırklareli University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years old and above, open to communication and cooperation,
- He will have planned heart surgery,
- He is sane,
- Not having a diagnosis of psychiatric disease or using psychiatric medication,
- Do not have sensory problems such as vision, hearing and speech,
- Literate,
- speaking Turkish,
- Patients who volunteered to participate in the study
Exclusion Criteria:
- Under the age of 18 and not open to communication and cooperation,
- Unplanned or emergency heart surgery,
- mentally ill
- Diagnosed with psychiatric illness and using psychiatric medication,
- Having sensory problems such as vision, hearing and speech
- Being illiterate
- Does not speak Turkish,
- Patients who did not volunteer to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Informing patients group
24-48 hours before the surgery, the patients will be shown an informative video about the intensive care environment in a separate room through a one-on-one interview.
In the study, the day of discharge from the intensive care unit will be counted as the first day, and on the second day, the 'Intensive Care Experience Scale' will be applied to the patients in the experimental group by face-to-face interview method.
|
24-48 hours before the surgery, the patients will be shown an informative video about the intensive care environment in a separate room through a one-on-one interview.
(The content of the training to be done with the video is stated in the appendix) In the study, no attempt will be made to the control group patients other than the routine practice of the institution before the surgery.
In the study, the day of discharge from the intensive care unit will be counted as the first day, and on the second day, the 'Intensive Care Experience Scale' will be applied to the patients in both the experimental and control groups by face-to-face interview method.
|
No Intervention: Control Group
patients who were no intervation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effect of preoperative video training on patients' intensive care experience
Time Frame: 1 year
|
The Intensive Care Experience Scale will be used for determining the effect of preoperative video training on patients' intensive care experience.
According to 19 items with scale, the individual may determine his or her experiences in intensive care unit.
The Intensive Care Experiences Scale are scored between 19 and 95.
The lowest score that can be obtained from the scale is 19, the highest score is 95.
As the total score obtained from the scale increases, it is evaluated that the patient's experience is positive and his awareness is high.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2022
Primary Completion (Actual)
December 25, 2022
Study Completion (Actual)
March 25, 2023
Study Registration Dates
First Submitted
February 15, 2022
First Submitted That Met QC Criteria
February 24, 2022
First Posted (Actual)
February 25, 2022
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 27, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- KırklareliUU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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