Endometrial BiopsyNCT06180317
The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy
A study testing Virtual reality in people with Endometrial Biopsy, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to reduce the anxiety and pain felt during endometrial biopsy procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Biopsy
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 28 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy: A Randomised Controlled Experimental Study
The aim of this study was to reduce the anxiety and pain felt during endometrial biopsy procedure.
Read the 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
- Being tested
- Virtual reality
- Keywords
- Endometrial Biopsy, Virtual Reality, Anxiety, Pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Experimental | Virtual reality to be applied to women undergoing endometrial biopsy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
The form consists of questions about socio-demographic and endometrial biopsy
Measured: between one to six months
Secondary outcomes (2)
The State/Trait Anxiety Inventory (STAI)
This inventory was developed by Spielberg in 1973 and each of the subscales ranges from 1 (not at all) to 4 (very much). The lowest and highest scores that can be obtained from each subscale are 20 and 80, respectively. Higher scores are associated with more anxiety. The alpha value of the scale varies between 0.86 and 0.92 . Öner et al. 1983, it was shown that the alpha value of the Turkish version of the STAI ranged between 0.83 and 0.87.27.
Measured: between one to six months
Visual Anolag Scale (VAS)
It was developed by Price et al. (1983) to assess the severity of pain. It is a line, usually 10 cm long, horizontal or vertical, starting with "No Pain" and ending with "Intolerable Pain". This line may be just a straight line, or it may be divided into equal intervals, or it may have description words placed on the line to describe pain. It is generally accepted that the vertical line is easier to understand. The patient indicates the intensity of his/her pain with a mark on this line where he/she deems appropriate. The distance between the beginning of no pain and this point is measured in "cm" and recorded. Values vary between 0 and 10 and higher values indicate increased pain. Turkish validity and reliability was performed by Eti Aslan.
Measured: between one to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Mar 2024
- Primary completion25 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- meltem yavuz, Midwife, Principal investigator, 1. Murat state hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180317
- Sponsor's protocol ID
- KırklareliED-3
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2023
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy: A Randomised Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT06180317
- Acronym / sponsor ID
- KırklareliED-3
- Conditions
- Endometrial Biopsy
- Keywords
- Endometrial Biopsy, Virtual Reality, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Other: Virtual realityVirtual reality to be applied to women undergoing endometrial biopsy. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityParticipants 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. | Other | Virtual reality group |
Primary outcome
Introductory Information Form
Time frame: between one to six months
The form consists of questions about socio-demographic and endometrial biopsy
2 secondary outcomes
The State/Trait Anxiety Inventory (STAI)
Time frame: between one to six months
Visual Anolag Scale (VAS)
Time frame: between one to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Endometrial Biopsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
meltem yavuz, Midwife principal investigator
1. Murat state hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Endometrial Biopsy, run by Kırklareli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: between one to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.