The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy

NCT ID: NCT06180317

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-11-28

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 problem.Endometrial 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 women's health. Although endometrial biopsy is a painless or mildly painful procedure, approximately half of the patients experience pain of different intensity during the procedure.Endometrial 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 women's 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.

Conditions

Endometrial Biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Virtual reality group

Virtual reality to be applied to women undergoing endometrial biopsy.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

Participants will view a specific relaxing and distracting scenario using virtual reality (VR) for approximately 7-8 minutes from one minute before the procedure until the end of the procedure. Assessment will be performed with STAI and VAS just before the endometrial biopsy procedure, VAS during the procedure and again with STAI and VAS after the procedure.

Control group

Participants in this group will consist of people who do not routinely do any practive on their own to reduce anxiety and pain during endometrial biopsy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality

Participants will view a specific relaxing and distracting scenario using virtual reality (VR) for approximately 7-8 minutes from one minute before the procedure until the end of the procedure. Assessment will be performed with STAI and VAS just before the endometrial biopsy procedure, VAS during the procedure and again with STAI and VAS after the procedure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• -Volunteering to participate in the research
• Answering questionnaire and scale forms completely
• Ability to read and understand Turkish
• 18 years of age or older
• STAI score of 35 and above

Exclusion Criteria

• Unwilling to continue working
• Having any problem that prevents communication (such as impaired hearing, speech, comprehension skills),
• Having used a pharmacological agent with analgesic or anxiolytic effect or a non-pharmacological method 24 hours before the procedure
• Having any psychiatric illness
• Vertigo, vision, hearing, perception problems
• Pregnancy
• Acute pelvic inflammatory disease, acute cervical and vaginal infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kırklareli University

OTHER

Sponsor Role: lead

Responsible Party

Ayca Solt Kirca

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

meltem yavuz, Midwife

Role: PRINCIPAL_INVESTIGATOR

1. Murat state hospital

Locations

1.Murat State Hospital

Edirne, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KırklareliED-3

Identifier Type: -

Identifier Source: org_study_id