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

NCT06180317 | Completed

• 1 other identifier: KırklareliED-3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to reduce the anxiety and pain felt during endometrial biopsy procedure.

Conditions

Endometrial Biopsy

Keywords

Endometrial Biopsy; Virtual Reality; Anxiety; Pain

Outcome Measures

Primary Outcomes (1)

• Introductory Information Form

  The form consists of questions about socio-demographic and endometrial biopsy

  between one to six months

Secondary Outcomes (2)

• The State/Trait Anxiety Inventory (STAI)

  between one to six months

• Visual Anolag Scale (VAS)

  between one to six months

Study Arms (2)

Virtual reality group

EXPERIMENTAL

Virtual reality to be applied to women undergoing endometrial biopsy.

Other: Virtual reality

Control group

NO INTERVENTION

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.

Interventions

Virtual reality 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.

Virtual reality group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

1.Murat State Hospital

Edirne, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• meltem yavuz, Midwife

  1. Murat state hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 22, 2023
• Study Start: March 1, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 28, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

TU (1)