Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180317
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-12-11
Brief Title:
The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy
Sponsor:
Kırklareli University
Organization:
Kırklareli University
Study Overview
Official Title:
The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy A Randomised Controlled Experimental Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The aim of this study was to reduce the anxiety and pain felt during endometrial biopsy procedure
Detailed Description:
Endometrial cancers are among the most common gynaecological cancers globally while abnormal uterine bleeding is a common gynaecological problemEndometrial biopsy is a safe method frequently used in gynaecology to evaluate abnormal or postmenopausal uterine bleeding It is a rapid and cost-effective medical procedure performed to examine the endometrium to detect the presence of endometrial hyperplasia malignancy or other pathological conditions
Since early diagnosis and correct treatment can affect the prognosis of the disease endometrial biopsy is considered an important diagnostic and screening tool for womens health Although endometrial biopsy is a painless or mildly painful procedure approximately half of the patients experience pain of different intensity during the procedureEndometrial biopsy which is an invasive procedure can trigger anxiety in women and increase the perceived pain experience and severity by reducing pain tolerance during the procedure
Effective management of anxiety which can also exacerbate the pain experienced during endometrial biopsy procedure can increase womens comfort and satisfaction Therefore anxiety management may be effective in helping women cope with the problems experienced during the endometrial biopsy procedure While many alternative methods are used to reduce anxiety in the literature acupressure meditation laughter therapy art therapy the therapeutic effect of virtual reality has also been reported in studies
Virtual reality VR is an interactive virtual environment dating back to the 1960s where the user experiences the virtual world by feeling there in the virtual world thanks to computer technologies It represents complex technologies in which visual auditory and tactile multisensory inputs are integrated into a 3D environment It is a virtual space that can include hand or body tracking sensors with a VR headset and expands up to 360 degrees offering users experiences similar to those in the real world In addition VR is frequently used in various sectors such as education gaming simulation and design as well as in the field of health A randomised clinical trial by Chiu et al showed that virtual reality was effective in reducing anxiety in patients The results of another study conducted by Yamashita et al revealed that virtual reality improved anxiety and pain
When the studies in the literature were examined no study on the effect of virtual reality on anxiety and pain that may be experienced during endometrial biopsy procedure was found In this study it was aimed to determine the effect of virtual reality use on anxiety and pain during endometrial biopsy
Since early diagnosis and correct treatment can affect the prognosis of the disease endometrial biopsy is considered an important diagnostic and screening tool for womens health Although endometrial biopsy is a painless or mildly painful procedure approximately half of the patients experience pain of different intensity during the procedureEndometrial biopsy which is an invasive procedure can trigger anxiety in women and increase the perceived pain experience and severity by reducing pain tolerance during the procedure
Effective management of anxiety which can also exacerbate the pain experienced during endometrial biopsy procedure can increase womens comfort and satisfaction Therefore anxiety management may be effective in helping women cope with the problems experienced during the endometrial biopsy procedure While many alternative methods are used to reduce anxiety in the literature acupressure meditation laughter therapy art therapy the therapeutic effect of virtual reality has also been reported in studies
Virtual reality VR is an interactive virtual environment dating back to the 1960s where the user experiences the virtual world by feeling there in the virtual world thanks to computer technologies It represents complex technologies in which visual auditory and tactile multisensory inputs are integrated into a 3D environment It is a virtual space that can include hand or body tracking sensors with a VR headset and expands up to 360 degrees offering users experiences similar to those in the real world In addition VR is frequently used in various sectors such as education gaming simulation and design as well as in the field of health A randomised clinical trial by Chiu et al showed that virtual reality was effective in reducing anxiety in patients The results of another study conducted by Yamashita et al revealed that virtual reality improved anxiety and pain
When the studies in the literature were examined no study on the effect of virtual reality on anxiety and pain that may be experienced during endometrial biopsy procedure was found In this study it was aimed to determine the effect of virtual reality use on anxiety and pain during endometrial biopsy
Study Oversight
Has Oversight DMC:
None
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?:
None