Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT07258420
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Watching Video With Virtual Reality Glasses During Surgery on Anxiety and Comfort Levels
Sponsor:
Trakya University
Organization:
Study Overview
Official Title:
The Effect of Using Virtual Reality Glasses on Patients' Anxiety and Comfort Levels in Open Inguinal Hernia Surgery Performed With Spinal Anesthesia
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted to evaluate the effect of using virtual reality glasses during surgery on patients' anxiety and comfort levels. The main hypotheses are as follows:
H1: 'During open inguinal hernia surgery performed with spinal anesthesia, anxiety levels of patients using virtual reality glasses are lower than those of patients who do not use them.' H2: It was determined that 'The comfort levels of patients who use virtual reality glasses during open inguinal hernia surgery performed with spinal anesthesia are higher than those of patients who do not use them'.
Participants will be asked to watch a video using VR goggles during surgery. If there is a comparison group: Researchers will compare patients to a control group to see if there are any differences in anxiety and comfort levels.
H1: 'During open inguinal hernia surgery performed with spinal anesthesia, anxiety levels of patients using virtual reality glasses are lower than those of patients who do not use them.' H2: It was determined that 'The comfort levels of patients who use virtual reality glasses during open inguinal hernia surgery performed with spinal anesthesia are higher than those of patients who do not use them'.
Participants will be asked to watch a video using VR goggles during surgery. If there is a comparison group: Researchers will compare patients to a control group to see if there are any differences in anxiety and comfort levels.
Detailed Description:
Randomization method will be used to determine the groups. Randomization of the patients was done using 'Random Allocation Software 2.0' program and they were divided into 2 groups: 1) Control group and 2) Intervention group.
1. Control Group: Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels.
2. Intervention Group: Patients in this group will be visited by the researcher in the pre-anesthesia recovery room in the operating room before surgery. Patients will be informed about the virtual reality glasses they will use during surgery. Patients will be asked to watch videos with virtual reality glasses during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess patients' anxiety levels; Perioperative Comfort Scale was used to assess their comfort levels.
1. Control Group: Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels.
2. Intervention Group: Patients in this group will be visited by the researcher in the pre-anesthesia recovery room in the operating room before surgery. Patients will be informed about the virtual reality glasses they will use during surgery. Patients will be asked to watch videos with virtual reality glasses during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess patients' anxiety levels; Perioperative Comfort Scale was used to assess their comfort levels.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: