Endometrial BiopsyNCT06961097
The Effect of Virtual Reality on Women Undergoing Endometrial Biopsy
A study testing Virtual Reality Group in people with Endometrial Biopsy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim was to determine the effect of nature sounds and images that will be shown to women who underwent endometrial biopsy by using virtual reality glasses on pain and anxiety. Hypotheses H0: Virtual reality glasses have no effect on women's pain and anxiety during endometrial biopsy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Biopsy
- What is being tested?
- Virtual Reality Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Jun 2026
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- *Being over 18 years old
- Speaking and understanding Turkish
- Being willing to participate in the research
Who cannot join
- Not volunteering to participate in research * Not speaking or understanding Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasess Application on Pain and Anxiety in Women Undergoing Endometrial Biopsy:A Randomized Controlled Research
The aim was to determine the effect of nature sounds and images that will be shown to women who underwent endometrial biopsy by using virtual reality glasses on pain and anxiety.
Hypotheses H0: Virtual reality glasses have no effect on women's pain and anxiety during endometrial biopsy.
Read more
H1: Virtual reality glasses have an effect on women's pain and anxiety during endometrial biopsy.
The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an endometrial biopsy. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sounds music of the video will be played in the practice room with a bluetooth speaker.
Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.
- Conditions
- Endometrial Biopsy
- Being tested
- Virtual Reality Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupOther
Also called control group
control group
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. After being taken to the gynecological table for the endometraial biopsy procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sound music of the video will be played. Receives: Other: Virtual Reality Group |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale
It was developed to measure the pain level of patients. It is named differently at two ends on a vertical or horizontal line of ten centimeters (cm) in length (0=no pain, 10=highest level of pain). The numerical values specified by the patient indicate the pain intensity. The validity and reliability of the scale have been performed. It has been determined that it is a suitable method for assessing the pain intensity.
Measured: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure
Change in anxiety
STAI-S It is a self-assessment type scale consisting of short statements. While the State Anxiety Inventory (SAI) provides information only about what is felt at that moment, the Trait Anxiety Inventory (TAI) was developed to measure what has been felt in the last 7 days. The SAI-SAI is a Likert-type scale consisting of 20 items and graded from 1 to 4. It is reported that the reliability coefficients obtained as a result of studies conducted with normal and patient samples of the scale vary between .83 and .87
Measured: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 May 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
- Investigators
- Sümeyye BAL, Ph.D., Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961097
- Sponsor's protocol ID
- 2025/7/4
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasess Application on Pain and Anxiety in Women Undergoing Endometrial Biopsy:A Randomized Controlled Research
- ClinicalTrials.gov ID
- NCT06961097
- Acronym / sponsor ID
- 2025/7/4
- Conditions
- Endometrial Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 7 May 2025 (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 was to determine the effect of nature sounds and images that will be shown to women who underwent endometrial biopsy by using virtual reality glasses on pain and anxiety.
Hypotheses H0: Virtual reality glasses have no effect on women's pain and anxiety during endometrial biopsy.
H1: Virtual reality glasses have an effect on women's pain and anxiety during endometrial biopsy.
The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an endometrial biopsy. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sounds music of the video will be played in the practice room with a bluetooth speaker.
Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality GroupIn addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. After being taken to the gynecological table for the endometraial biopsy procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sound music of the video will be played. |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- *Being over 18 years old
Key exclusion criteria (1 listed)
- Not volunteering to participate in research * Not speaking or understanding Turkish
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 Reality GroupAlso: control groupcontrol group | Other | Virtual Reality Group |
Primary outcome
Numerical Pain Scale
Time frame: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure
It was developed to measure the pain level of patients. It is named differently at two ends on a vertical or horizontal line of ten centimeters (cm) in length (0=no pain, 10=highest level of pain). The numerical values specified by the patient indicate the pain intensity. The validity and reliability of the scale have been performed. It has been determined that it is a suitable method for assessing the pain intensity.
Change in anxiety
Time frame: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure
STAI-S It is a self-assessment type scale consisting of short statements. While the State Anxiety Inventory (SAI) provides information only about what is felt at that moment, the Trait Anxiety Inventory (TAI) was developed to measure what has been felt in the last 7 days. The SAI-SAI is a Likert-type scale consisting of 20 items and graded from 1 to 4. It is reported that the reliability coefficients obtained as a result of studies conducted with normal and patient samples of the scale vary between .83 and .87
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sümeyye BAL, Ph.D. study director
Ondokuz Mayıs University
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 Group in people with Endometrial Biopsy, run by Ondokuz Mayıs 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 3 inclusion and 1 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 27 Jul 2026. 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?
Numerical Pain Scale (time frame: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure). The study lists 2 primary outcomes in all. 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 27 Jul 2026.