Surgery Clinical Trial
Official title:
The Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety in Patients Planned for Open Heart Surgery
NCT number | NCT06127758 |
Other study ID # | 0031 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2023 |
Est. completion date | June 2024 |
Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research. Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale. Hypothesis of the Research: H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery. H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | June 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years and over, - Those who will undergo open heart surgery, - Those who have not had cardiovascular surgery before, - No communication problems, - Is conscious and able to answer questions and does not have any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.), - Does not have a psychiatric disease such as anxiety disorder, panic attack, depression, - Individuals who do not receive psychiatric treatment such as antipsychotics/anxiolytics will be included in the study. Exclusion Criteria: - Being under the age of 18, - Not having open heart surgery, - Those who have previously undergone cardiovascular surgery, - Having communication problems, - Those who are unconscious and unable to answer questions Having any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.), - Having a psychiatric disease such as anxiety disorder, panic attack, depression, - Individuals receiving psychiatric treatment such as antipsychotic/anxiolytic will not be included in the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Uskudar University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Personal Information Form | The form prepared by the researchers contains a total of 8 questions containing the patients' introductory information. | for 1 day | |
Primary | surgical fear scale | There are 8 questions in the scale. The scale is an 11-point Likert type scale with a score between 0 and 10. The scale included two subscales related to the source of fear, each consisting of 4 items. While items 1 to 4 on the scale measure the fear of the short-term consequences of surgery, items 5 to 8 measure the fear of the long-term consequences of surgery (0: not at all afraid, 10: very afraid). An increase in the score indicates an increase in fear. | for 1 day | |
Primary | state anxiety scale | It consists of a total of 40 items and is scored from 1 to 4. Scale items are evaluated using the "Likert type" scaling method as "1 = not at all", "2 = a little", "3 = a lot", "4 = completely". A high score on the scale indicates a high level of anxiety; A low score indicates a low level of anxiety. In the validity and reliability study of the scale, the alpha value was found to be 0.91. | for 1 day |
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