- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07294690
The Effect of Preoperative Training With Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery
The aim of the study is to determine the effect of The Effect of Preoperative Training with Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery.
Research Hypotheses
In patients undergoing colorectal surgery:
H1 The comfort level of patients who received preoperative training using virtual reality is higher than that of patients who received training using written brochures and the control group.
H2. The anxiety level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.
H3 The satisfaction level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Özkan Karadede, MsC
- Phone Number: +905067705766
- Email: ozkan.karadede@iuc.edu.tr
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34090
- Recruiting
- Istanbul University-Cerrahpasa
-
Contact:
- Özkan Karadede, Msc
- Phone Number: +905067705766
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Agreement to participate in the study, Ability to read and write in Turkish, Being conscious and communicative.
Exclusion Criteria:
Those with any psychiatric illness, Those diagnosed with an anxiety disorder and taking medication for anxiety, Those with active nausea, vomiting, or headache, Those with vision or hearing problems, Those with a history of seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Experimental: virtual reality group
Patients undergoing colorectal surgery will be trained using virtual reality glasses.
|
Patients undergoing colorectal surgery will be trained using virtual reality glasses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(State Trait Anxiety Inventory I-II)
Time Frame: 24 hour
|
STAI I determines how an individual feels at a specific moment and under specific conditions. The State-Trait Anxiety Inventory (STAI II) determines how individuals generally feel in their current situation and conditions. Inventory items are scored between 1 and 4. High scores on the inventory indicate that the person has high levels of state and trait anxiety. Scores between 0 and 19 on the inventory indicate no anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-80 points indicate severe anxiety. |
24 hour
|
|
The Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ)
Time Frame: 24 hour
|
The scale determines whether the verbal and written information provided about the surgery prepares individuals for the surgery.
The scale is a 4-point Likert scale ranging from positive to negative.
The scale consists of a total of 24 items.
The score that can be obtained from the scale ranges from 0 to 96.
Item 24 on the scale is reverse-scored.
The scale is evaluated by calculating the total score of the items.
High scores indicate a high level of readiness.
|
24 hour
|
|
Recovery Quality-40 Survey (QoR-40)
Time Frame: 24 hour
|
The scale consists of a total of 40 items.
It comprises five subscales: emotional state, physical comfort, patient support, physical independence, and pain.
The scale is a 5-point Likert scale, and items are scored on a scale of 1 to 5. Subscale averages are obtained by summing the scores for each subscale, and the total survey score is obtained by summing all items.
A higher score indicates that patients' physical and emotional well-being is at the expected level (good condition) post-surgery.
A low score indicates that the patient's well-being post-surgery has been negatively affected.
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortisol Level
Time Frame: 24 hour
|
Cortisol, commonly known as the "stress hormone," is essential for life.
When stress occurs, cortisol levels increase.
Cortisol is secreted by the adrenal cortex in response to various stimuli.
It enables the organism to adapt to its environment.
Cortisol helps the organism defend against dangers by enhancing its homeostasis ability.
Cortisol levels were measured using saliva samples taken at specified times.
|
24 hour
|
|
Number of Steps
Time Frame: 24 hour
|
A pedometer wristband was used to monitor the patient's daily physical activities and determine the number of steps taken.
|
24 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-83045809-604.01-1017096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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