Pelvic Examination,Virtual RealityNCT05545488
Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination
A study testing Virtual reality in people with Pelvic Examination,Virtual Reality, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study was conducted as a randomized controlled experimental study to examine the effect of the video watched with virtual reality glasses during the pelvic examination on the level of pain and anxiety perceived by women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pelvic Examination,Virtual Reality
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 15 Mar 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-40
- Being able to read and write
- To be competent to express oneself
- Having applied to the outpatient clinic for any gynecological complaint (bleeding, menstrual cycle irregularity, discharge, itching...) or for routine gynecological control.
Who cannot join
- Having a current pregnancy
- Complaining of acute pelvic pain
- Having any damage or lesion in the perineum that may cause pain during the examination
- Having used a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the examination
- Having a vaginismus problem
- Having any physical or mental problems that may prevent communication
Trial locations and contacts
1 site in 1 country.
About this study
Objective: The study was conducted as a randomized controlled experimental study to examine the effect of the video watched with virtual reality glasses during the pelvic examination on the level of pain and anxiety perceived by women.
Materials-Methods: The sample of the study consisted of 128 women (64 experimental, 64 control group) who applied to the Obstetrics and Gynecology Polyclinics with non-pregnancy complaints between November 2021 and February 2022, volunteered to participate in the study and were approved by the doctor for pelvic examination. Institutional and ethical committee permissions were obtained before starting the study. Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (GDS), Pelvic Examination Experience Evaluation Questionnaire, and Questionnaire Evaluating Non-Verbal Responses to Emotional Stressful Situations, prepared by the researcher, were used to collect data. In the pre-test to the women in the experimental group of the study: Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination + Virtual reality application (using virtual reality glasses for a minimum of 5 maximum 15 minutes), Emotional Stress to be applied by the researcher The Form Evaluating Non-Verbal Responses to the Creating Situations, and in the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. In the pre-test to the women in the control group of the study: Introductory Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination (routine service), Form Evaluating Non-Verbal Responses to Emotional Stressing Situations to be administered by the Researcher, In the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. Data were evaluated in computer environment and using SPSS 23.0 statistical package program. A p value of <.05 for the data was considered statistically significant.
- Conditions
- Pelvic Examination,Virtual Reality
- Being tested
- Virtual reality
- Keywords
- Pelvic Exam, Pain, Anxiety, Virtual Reality
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
I had the women wear virtual reality glasses and watch the video they wanted for at least 5, maximum 15 minutes during the examination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Before preparing for pelvic training, information was given about virtual training applications, 1-2 minutes of practical information about both virtual glasses and pelvic training. Afterwards, the woman was taken to the gynecological examination table and, as the doctor began the examination, virtual glasses were put on the woman and a virtual reality application containing both sound and image was performed for 5-15 minutes. In the meantime, the pelvic examination was performed by the physician, the researcher accompanied the woman at all stages of the pelvic examination process and provided care based on ethical principles, which cared for the woman, respected, protected privacy. Receives: Device: Virtual reality |
| Control group | No intervention | The control group was accompanied by the woman at all stages of the pelvic examination process, and the care service that cared for the woman, was respectful, privacy was protected and based on ethical principles was given in the same way, but the virtual glasses initiative was not applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
The visual comparison scale,(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity.
Measured: 15 minutes
Anxiety level
The visual comparison scale and the state anxiety scale were evaluated.(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity. State Anxiety Scale(STAI FORM TX - I) It is an inventory in which state anxiety is evaluated. The scores vary between 20 and 80 points. With the increase in the score, the level of anxiety also increases.
Measured: 15 minutes
Pelvic examination using virtual reality glasses
Before the video, anxiety is evaluated with a visual comparison scale, then videos with nature, rain, water, flower scenes are watched for 5 to 15 minutes by wearing virtual reality glasses. Afterwards, anxiety and pain are evaluated with state anxiety scale and visual comparison scale. All results SPSS 23.0 It is analyzed by the program.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start15 Dec 2021
- Primary completion15 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pelvic Examination,Virtual RealityStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay KURT, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545488
- Sponsor's protocol ID
- 2021/20
- Status last verified
- Sep 2022
- First submitted
- 22 Aug 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ACOG Committee Opinion No. 754: The Utility of and Indications for Routine Pelvic Examination. Obstet Gynecol. 2018 Oct;132(4):e174-e180. doi: 10.1097/AOG.0000000000002895.
PubMed 30247363Bates CK, Carroll N, Potter J. The challenging pelvic examination. J Gen Intern Med. 2011 Jun;26(6):651-7. doi: 10.1007/s11606-010-1610-8. Epub 2011 Jan 12.
PubMed 21225474Davisson L, Clark K, Powers R, Hobbs G. The rectovaginal examination: physician attitudes and practice patterns. South Med J. 2006 Mar;99(3):212-5. doi: 10.1097/01.smj.0000203334.80885.de.
PubMed 16553094Granberg S, Wikland M. A comparison between ultrasound and gynecologic examination for detection of enlarged ovaries in a group of women at risk for ovarian carcinoma. J Ultrasound Med. 1988 Feb;7(2):59-64. doi: 10.7863/jum.1988.7.2.59.
PubMed 3279225Hassan SJ, Sundby J, Husseini A, Bjertness E. The paradox of vaginal examination practice during normal childbirth: Palestinian women's feelings, opinions, knowledge and experiences. Reprod Health. 2012 Aug 28;9:16. doi: 10.1186/1742-4755-9-16.
PubMed 22929060Ying Lai C, Levy V. Hong Kong Chinese women's experiences of vaginal examinations in labour. Midwifery. 2002 Dec;18(4):296-303. doi: 10.1054/midw.2002.0326.
PubMed 12473444Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
PubMed 19272275Peeker R, Enerback L, Fall M, Aldenborg F. Recruitment, distribution and phenotypes of mast cells in interstitial cystitis. J Urol. 2000 Mar;163(3):1009-15.
PubMed 10688040Ueland FR, Depriest PD, Desimone CP, Pavlik EJ, Lele SM, Kryscio RJ, van Nagell JR Jr. The accuracy of examination under anesthesia and transvaginal sonography in evaluating ovarian size. Gynecol Oncol. 2005 Nov;99(2):400-3. doi: 10.1016/j.ygyno.2005.06.030. Epub 2005 Aug 9.
PubMed 16084576Swahnberg K, Wijma B, Siwe K. Strong discomfort during vaginal examination: why consider a history of abuse? Eur J Obstet Gynecol Reprod Biol. 2011 Aug;157(2):200-5. doi: 10.1016/j.ejogrb.2011.02.025. Epub 2011 Apr 5.
PubMed 21470763Kurt G, Ozcan NK. The Effect of Virtual Reality On Pain and Anxiety Management During Pelvic Examination: A Randomized Controlled Trial. J Midwifery Womens Health. 2024 Jul-Aug;69(4):543-549. doi: 10.1111/jmwh.13587. Epub 2024 Jan 4.
PubMed 38178322
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Virtual Reality on Pain and Anxiety Management During Pelvic Examination
- ClinicalTrials.gov ID
- NCT05545488
- Acronym / sponsor ID
- 2021/20
- Conditions
- Pelvic Examination,Virtual Reality
- Keywords
- Pelvic Exam, Pain, Anxiety, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 19 Sep 2022 (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.
Objective: The study was conducted as a randomized controlled experimental study to examine the effect of the video watched with virtual reality glasses during the pelvic examination on the level of pain and anxiety perceived by women.
Materials-Methods: The sample of the study consisted of 128 women (64 experimental, 64 control group) who applied to the Obstetrics and Gynecology Polyclinics with non-pregnancy complaints between November 2021 and February 2022, volunteered to participate in the study and were approved by the doctor for pelvic examination. Institutional and ethical committee permissions were obtained before starting the study. Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (GDS), Pelvic Examination Experience Evaluation Questionnaire, and Questionnaire Evaluating Non-Verbal Responses to Emotional Stressful Situations, prepared by the researcher, were used to collect data. In the pre-test to the women in the experimental group of the study: Descriptive Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination + Virtual reality application (using virtual reality glasses for a minimum of 5 maximum 15 minutes), Emotional Stress to be applied by the researcher The Form Evaluating Non-Verbal Responses to the Creating Situations, and in the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. In the pre-test to the women in the control group of the study: Introductory Information Form, State Anxiety Scale, Visual Comparison Scale (for anxiety), then Pelvic examination (routine service), Form Evaluating Non-Verbal Responses to Emotional Stressing Situations to be administered by the Researcher, In the post-test: State Anxiety Scale, Visual Comparison Scale (anxiety + pain), Pelvic Examination Experience Evaluation Questionnaire were applied. Data were evaluated in computer environment and using SPSS 23.0 statistical package program. A p value of <.05 for the data was considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Virtual realityBefore preparing for pelvic training, information was given about virtual training applications, 1-2 minutes of practical information about both virtual glasses and pelvic training. Afterwards, the woman was taken to the gynecological examination table and, as the doctor began the examination, virtual glasses were put on the woman and a virtual reality application containing both sound and image was performed for 5-15 minutes. In the meantime, the pelvic examination was performed by the physician, the researcher accompanied the woman at all stages of the pelvic examination process and provided care based on ethical principles, which cared for the woman, respected, protected privacy. |
| Control group | No intervention | –The control group was accompanied by the woman at all stages of the pelvic examination process, and the care service that cared for the woman, was respectful, privacy was protected and based on ethical principles was given in the same way, but the virtual glasses initiative was not applied. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-40
- Being able to read and write
- To be competent to express oneself
- Having applied to the outpatient clinic for any gynecological complaint (bleeding, menstrual cycle irregularity, discharge, itching...) or for routine gynecological control.
Key exclusion criteria (6 listed)
- Having a current pregnancy
- Complaining of acute pelvic pain
- Having any damage or lesion in the perineum that may cause pain during the examination
- Having used a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the examination
- Having a vaginismus problem
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 realityI had the women wear virtual reality glasses and watch the video they wanted for at least 5, maximum 15 minutes during the examination. | Device | Experimental group |
Primary outcome
Pain level
Time frame: 15 minutes
The visual comparison scale,(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity.
Anxiety level
Time frame: 15 minutes
The visual comparison scale and the state anxiety scale were evaluated.(VAS).The visual analog scale has a score from 1 to 10. The higher the score, the higher the pain intensity. State Anxiety Scale(STAI FORM TX - I) It is an inventory in which state anxiety is evaluated. The scores vary between 20 and 80 points. With the increase in the score, the level of anxiety also increases.
Pelvic examination using virtual reality glasses
Time frame: 15 minutes
Before the video, anxiety is evaluated with a visual comparison scale, then videos with nature, rain, water, flower scenes are watched for 5 to 15 minutes by wearing virtual reality glasses. Afterwards, anxiety and pain are evaluated with state anxiety scale and visual comparison scale. All results SPSS 23.0 It is analyzed by the program.
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 19 Sep 2022.
- Background: PubMed 30247363ACOG Committee Opinion No. 754: The Utility of and Indications for Routine Pelvic Examination. Obstet Gynecol. 2018 Oct;132(4):e174-e180. doi: 10.1097/AOG.0000000000002895.
- Background: PubMed 21225474Bates CK, Carroll N, Potter J. The challenging pelvic examination. J Gen Intern Med. 2011 Jun;26(6):651-7. doi: 10.1007/s11606-010-1610-8. Epub 2011 Jan 12.
- Background: PubMed 16553094Davisson L, Clark K, Powers R, Hobbs G. The rectovaginal examination: physician attitudes and practice patterns. South Med J. 2006 Mar;99(3):212-5. doi: 10.1097/01.smj.0000203334.80885.de.
- Background: PubMed 3279225Granberg S, Wikland M. A comparison between ultrasound and gynecologic examination for detection of enlarged ovaries in a group of women at risk for ovarian carcinoma. J Ultrasound Med. 1988 Feb;7(2):59-64. doi: 10.7863/jum.1988.7.2.59.
- Background: PubMed 22929060Hassan SJ, Sundby J, Husseini A, Bjertness E. The paradox of vaginal examination practice during normal childbirth: Palestinian women's feelings, opinions, knowledge and experiences. Reprod Health. 2012 Aug 28;9:16. doi: 10.1186/1742-4755-9-16.
- Background: PubMed 12473444Ying Lai C, Levy V. Hong Kong Chinese women's experiences of vaginal examinations in labour. Midwifery. 2002 Dec;18(4):296-303. doi: 10.1054/midw.2002.0326.
- Background: PubMed 19272275Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
- Background: PubMed 10688040Peeker R, Enerback L, Fall M, Aldenborg F. Recruitment, distribution and phenotypes of mast cells in interstitial cystitis. J Urol. 2000 Mar;163(3):1009-15.
- Background: PubMed 16084576Ueland FR, Depriest PD, Desimone CP, Pavlik EJ, Lele SM, Kryscio RJ, van Nagell JR Jr. The accuracy of examination under anesthesia and transvaginal sonography in evaluating ovarian size. Gynecol Oncol. 2005 Nov;99(2):400-3. doi: 10.1016/j.ygyno.2005.06.030. Epub 2005 Aug 9.
- Background: PubMed 21470763Swahnberg K, Wijma B, Siwe K. Strong discomfort during vaginal examination: why consider a history of abuse? Eur J Obstet Gynecol Reprod Biol. 2011 Aug;157(2):200-5. doi: 10.1016/j.ejogrb.2011.02.025. Epub 2011 Apr 5.
- Derived from this study: PubMed 38178322Kurt G, Ozcan NK. The Effect of Virtual Reality On Pain and Anxiety Management During Pelvic Examination: A Randomized Controlled Trial. J Midwifery Womens Health. 2024 Jul-Aug;69(4):543-549. doi: 10.1111/jmwh.13587. Epub 2024 Jan 4.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pelvic Examination,Virtual Reality, run by Istanbul University - Cerrahpasa 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 4 inclusion and 6 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 19 Sep 2022. 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?
Pain level (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05545488, which also lists 11 linked publications.
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 19 Sep 2022.