- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297095
The Effect of Virtual Reality Education on Preoperative Anxiety, Postoperative Pain, and Sleep in Patients Undergoing Colon Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Ankara, Turkey (Türkiye)
- Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who agree to participate in the study will be included:
They are undergoing surgery for the first time,
They have not received preoperative training,
They will undergo colon surgery,
They are over 18 years of age,
They are eligible for the Virtual Reality Discomfort Questionnaire,
They do not have claustrophobia.
Exclusion Criteria:
- Patients who have had multiple surgeries, Patients with head and neck, vision, or hearing problems that prevent them from wearing virtual reality glasses, Patients who had a stoma created during surgery, Patients who wish to withdraw from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental
Participants in the intervention group will receive training in the patient room of the General Surgery Clinic using a training video prepared with virtual reality glasses.
The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors.
On the first postoperative day, the Richards Campbell Sleep Scale will be administered to the intervention and control groups.
At 8, 16, and 24 hours, the intervention and control groups will be assessed for pain intensity using the Visual Analog Scale (VAS).
|
In the General Surgery Clinic, intervention group participants will receive training in the patient room using a virtual reality headset.
The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors.
A training video will be prepared explaining that the patient will be monitored upon returning to the room after the surgery, will be monitored frequently, will be questioned about pain and sleep, and that their family and nurse will be available for any needs they may have.
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No Intervention: control group
The control group will receive routine verbal training as applied in the classical hospital procedure.
The control group will receive routine verbal training as applied in the classical hospital procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Visual Analog Scale (VAS) Richard Campbell Sleep Quality Scale Surgical Anxiety Scale
Time Frame: 6 month
|
The Visual Analog Scale (VAS) will be used in the study to assess patients' pain. It is a simple, effective, repeatable, and minimally instrumental measurement tool. Richard Campbell Sleep Quality Scale Developed by Richards, this six-item scale measures the depth and quality of nighttime sleep, time to fall asleep, frequency of awakenings and duration of wakefulness, and ambient noise. Surgical Anxiety Scale The scale has three subscales: health-related anxiety, recovery-related anxiety, and procedure-related anxiety. |
6 month
|
Collaborators and Investigators
Investigators
- Study Director: Sema Koçaşlı, Assist. Prof. Dr., Ankara Yildirim Beyazıt University
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
- 08/832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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