Cervical DysplasiaNCT04751799
Virtual Reality: Influence on Satisfaction, Pain, and Anxiety in Patients Undergoing Colposcopy
A study testing Virtual reality headset before colposcopy and Virtual reality headset during colposcopy in people with Cervical Dysplasia and Pain, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Cervical cancer is one of the most common cancers in women and one of the leading causes of death in women worldwide. Pre-cancerous lesions (dysplasias) are detected by the screening smear test at the gynecologist's office and can thus contribute to a 100% chance of cure if they are clarified by a colposcopic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dysplasia, Pain, Anxiety
- What is being tested?
- Virtual reality headset before colposcopy and Virtual reality headset during colposcopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteGermany
- Study dates
- 25 May 2021to 10 Jul 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent to participate in the study
- Clinically indicated colposcopy in case of abnormal PAP smear for detection of precancerous lesions of the cervix uteri and/or clinical abnormality of the cervix uteri (e.g. leukoplakia) with biopsy
Who cannot join
- Eye diseases (e.g., glaucoma/cataracts) that impair viewing of VR content.
- Claustrophobia/agoraphobia or epilepsy
- Patients with insufficient knowledge of the German language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a VR Headset on Pain Perception and Satisfaction During Colposcopic Workup of Cervical Precancerous Lesions: a Multicenter Randomized-controlled Trial.
Cervical cancer is one of the most common cancers in women and one of the leading causes of death in women worldwide. Pre-cancerous lesions (dysplasias) are detected by the screening smear test at the gynecologist's office and can thus contribute to a 100% chance of cure if they are clarified by a colposcopic examination as part of the dysplasia consultation.
To detect cervical dysplasia during colposcopic examination, the effect of diluted acetic acid on the epithelium of the cervix uteri is utilized. Metaplastic epithelium and low-grade dysplasia are visually noticeable by a slight white staining. Biopsies are then taken from these areas for further diagnosis.
Read more
The colposcopy itself and especially the colposcopic targeted biopsy of the cervix are painful. Virtual reality (VR) is a new method for 360° three-dimensional viewing of image content. A number of studies have shown that the use of VR can have a positive impact on the course of medical interventions. Randomized studies on the effectiveness of VR in a collective of women with colposcopically targeted biopsy of the cervix are not available according to a recent literature search (PubMed search of 12/30/2020; search terms: cervical biopsy, colposcopy, pain relief, pain control, virtual reality). In studies of our research group on colposcopy, we found increased pain scores especially in younger patients, but also in obese patients and smokers. A controlled study on the effectiveness of VR in colposcopically targeted biopsy is therefore useful.
In our study, we now want to answer the question under prospective conditions whether the use of VR before the start or before the start and during colposcopy compared to no intervention leads to a significant increase in patient satisfaction and/or a reduction in pain in the context of clarification colposcopy and colposcopically targeted biopsy.
Read the detailed description
HPV and cervical cancer
Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide. The prevalence in the population is high. Epidemiological estimates suggest that 75-80% of sexually active adults acquire an HPV infection in the genital area at least once by the age of 50. However, up to 95% of these HPV infections are considered harmless and are spontaneously eliminated within 2 years in terms of immunological HPV clearance [1]. On the other hand, persistent infections with HPV of the high-risk group, e.g. HPV-16 and HPV-18, are the main cause for the development of cervical carcinoma and are also partly responsible for the development of vulvar carcinoma, vaginal carcinoma and anal carcinoma. HPV preferentially infects the epithelial cells of the anogenital region and, through incorporation of HPV DNA into the host genome and subsequent interference with the cell cycle control of the host cell, causes changes in the cervical epithelium that, if left untreated, may develop into precancerous lesions (so-called cervical intraepithelial neoplasia) and consecutively into invasive carcinoma of the cervix (cervical carcinoma). Specifically, the viral protooncogene E6 gene product couples to p53 and promotes its degradation, and the viral protooncogene E7 gene product forms a complex with the retinoblastoma gene product pRB and suppresses its tumor suppressor function [2]. Both the impairment of apoptosis and tumor suppressor function promote immortalization of infected basal cells in the transformation zone of the cervix uteri.
Cervical carcinoma is the third most common cancer in women worldwide, as well as the fourth leading cause of death in women worldwide. Cervical carcinoma accounted for 9% (n=529 800) of all new cancer cases and 8% (n=275 100) of cancer-related deaths in women in 2008 [3].
The precursor of cervical cancer is cervical intraepithelial neoplasia (CIN), which can lead to the development of squamous cell carcinoma (approximately 80% of all cervical cancers). Three grades of expression are distinguished in CIN (CIN1, CIN 2, and CIN 3). Compared with invasive cervical carcinoma, the occurrence of precancerous lesions of the cervix uteri is more widespread. It is estimated that approximately 100,000 women in Germany develop new dysplasias (CIN 1-3) annually, with a point prevalence of >200,000 [3, 4].
Colposcopy as a diagnostic method
Dysplasia of the cervix typically becomes conspicuous during the gynecological screening examination at the gynecologist. In this case, smears are taken from the ectocervix and endocervix and assessed by the cytologist after a Papanicolaou stain has been performed with regard to dysplastic cells and the quality of the smear. For further clarification of dysplastic changes, presentation to a specialized dysplasia consultation is recommended. During colposcopic examination, histological confirmation of dysplastic areas is performed by means of biopsy.
Colposcopy (visual examination of the vagina and the entrance to the uterus with optical magnification) is an integral part of early cervical cancer detection. It is used to visualize dysplastic areas on the cervix uteri and to determine their spatial expression. The magnifying glass allows a multilevel (3.5 to 30x) two-dimensional magnification. After visual identification of suspicious areas using 5% acetic acid (dysplasias become acetic white) and classification into "minor" (grade 1) or "major" (grade 2) changes according to the internationally used RIO classification, a targeted biopsy for exact determination of the degree of dysplasia is possible [4]. Only in this way is further individual therapy planning possible.
Pain sensation during colposcopic examination.
Colposcopy itself and especially colposcopic targeted biopsy of the cervix are painful [4, 5]. General practice is to use local analgesics, oral analgesics, or no analgesics during a colposcopically targeted biopsy of the cervix [5]. The use of nonpharmacologic methods to positively influence patient pain perception and satisfaction has been investigated in a number of studies. For example, in a prospective randomized study, our group demonstrated that classical music (Mozart, Symphony No. 40 in G minor, KV 550) [6] had no positive influence on satisfaction and pain perception. Similarly, in another randomized study, we found no positive influence on satisfaction and pain perception by using video colposcopy [7]. Virtual reality (VR) is a new method for 360° three-dimensional viewing of image content. A number of studies have shown that the use of VR can have a positive effect on the course of medical interventions. For example, in a systematic review and meta-analysis of 8 randomized trials with a total of 723 subjects, Ding et al showed lower postoperative pain scores after the application of VR in the context of various surgeries such as dental, knee, hemorrhoid surgery, and obstetric injury care [8].
Randomized trials of the effectiveness of VR in a collective of women undergoing colposcopy-targeted cervical biopsy are not available according to a recent literature search (PubMed search as of 12/30/2020; search terms: cervical biopsy, colposcopy, pain relief, pain control, virtual reality). In studies of our research group on colposcopy, we found increased pain scores especially in younger patients, but also in obese patients and smokers [7, 9]. Therefore, a controlled study on the effectiveness of VR in colposcopy-targeted biopsy is reasonable.
Aim of the study
Our study now aims to answer the question under prospective conditions whether the use of VR before initiation or before initiation and during colposcopy compared to no intervention leads to a significant increase in patient satisfaction and/or a reduction in pain in the context of clarification colposcopy and colposcopically targeted biopsy.
References
- Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006;55:1-94.
- Münger K, Scheffner M, Huibregtse JM, Howley PM. Interactions of HPV E6 and E7 oncoproteins with tumour suppressor gene products. Cancer Surv. 1992;12:197-217.
- Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015;65:87-108. doi:10.3322/caac.21262.
- Kühn W. Kolposkopie zur Früherkennung des Zervixkarzinoms. Pathologe. 2011;32:497-504. doi:10.1007/s00292-011-1480-9.
- Heinrich J, Kühn W. Kolposkopie in Klinik und Praxis. 2nd ed. Berlin: De Gruyter; 2013.
- Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018;132:1047-55. doi:10.1097/AOG.0000000000002876.
- Hilal Z, Alici F, Tempfer CB, Seebacher V, Rezniczek GA. Video Colposcopy for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2017;130:411-9. doi:10.1097/AOG.0000000000002127.
- Ding L, Hua H, Zhu H, Zhu S, Lu J, Zhao K, Xu Q. Effects of virtual reality on relieving postoperative pain in surgical patients: A systematic review and meta-analysis. Int J Surg. 2020;82:87-94. doi:10.1016/j.ijsu.2020.08.033.
- Hilal Z, Rezniczek GA, Tettenborn Z, Hefler LA, Tempfer CB. Efficacy of Monsel Solution After Cervical Biopsy: A Randomized Trial. J Low Genit Tract Dis. 2016;20:312-6. doi:10.1097/LGT.0000000000000234.
- Laux L, Glanzmann P, Schaffner P, Spielberger CD. Das State-Trait-Angstinventar (STAI). Theoretische Grundlagen und Handlungsanweisungen. Weinheim: Beltz; 1981.
- Bornstein J, Bentley J, Bösze P, Girardi F, Haefner H, Menton M, et al. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol. 2012;120:166-72. doi:10.1097/AOG.0b013e318254f90c.
- Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377-81. doi:10.1016/j.jbi.2008.08.010.
- Conditions
- Cervical Dysplasia, Pain, Anxiety
- Being tested
- Virtual reality headset before colposcopy, Virtual reality headset during colposcopy
- Keywords
- colposcopy, virtual reality, cervical dysplasia, pain, anxiety
- Medical subject headings
- Uterine Cervical Dysplasia, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headset before colposcopyDevice
Patients wear a virtual headset presenting 360° 3D views of relaxing environments
Virtual reality headset during colposcopyDevice
Patients wear a virtual headset presenting 360° 3D views of distracting environments
| Study group | Role | What they receive |
|---|---|---|
| Control Group (no VR) | No intervention | Patients undergoing colposcopy and colposcopically-guided biopsy without further intervention |
| VR before and during colposcopy | Experimental | Patients undergoing colposcopy and colposcopically-guided biopsy with a VR headset for 15 minutes before colposcopy as well as during colposcopy. Receives: Device: Virtual reality headset before colposcopy; Device: Virtual reality headset during colposcopy |
| VR before colposcopy | Experimental | Patients undergoing colposcopy and colposcopically-guided biopsy with a VR headset for 15 minutes before colposcopy but not during colposcopy. Receives: Device: Virtual reality headset before colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
11-item VAS (0 = not satisfied at all, 10 = totally satisfied)
Measured: immediately after procedure
Secondary outcomes (4)
Patient pain
11-item VAS (0 = no pain, 10 = worst imaginable pain)
Measured: during the colposcopy
Patient pain
11-item VAS (0 = no pain, 10 = worst imaginable pain)
Measured: immediately after the colposcopy
Patient anxiety
11-item VAS (0 = not anxious at all, 10 = very anxious)
Measured: during the colposcopy
Surgical complications
Questionnaire (mail-back or online) regarding pain, self-medicated pain medication, bleeding duration.
Measured: 72 hours after colposcopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start25 May 2021
- Primary completion7 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DysplasiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized open interventional study
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Günther Rezniczek, Ruhr University of Bochum
- Investigators
- Clemens B Tempfer, MD, Study chair, Ruhr-Universität Bochum / Marien Hospital Herne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751799
- Sponsor's protocol ID
- VR-1
- Status last verified
- Apr 2024
- First submitted
- 3 Feb 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hecken JM, Halagiera P, Rehman S, Tempfer CB, Rezniczek GA. Virtual Reality for Anxiety Reduction in Women Undergoing Colposcopy: A Randomized Controlled Trial. J Low Genit Tract Dis. 2023 Jul 1;27(3):223-229. doi: 10.1097/LGT.0000000000000745. Epub 2023 May 11.
PubMed 37166026
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a VR Headset on Pain Perception and Satisfaction During Colposcopic Workup of Cervical Precancerous Lesions: a Multicenter Randomized-controlled Trial.
- ClinicalTrials.gov ID
- NCT04751799
- Acronym / sponsor ID
- VR-1
- Conditions
- Cervical Dysplasia, Pain, Anxiety
- Keywords
- colposcopy, virtual reality, cervical dysplasia, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 12 Feb 2021 (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.
Cervical cancer is one of the most common cancers in women and one of the leading causes of death in women worldwide. Pre-cancerous lesions (dysplasias) are detected by the screening smear test at the gynecologist's office and can thus contribute to a 100% chance of cure if they are clarified by a colposcopic examination as part of the dysplasia consultation.
To detect cervical dysplasia during colposcopic examination, the effect of diluted acetic acid on the epithelium of the cervix uteri is utilized. Metaplastic epithelium and low-grade dysplasia are visually noticeable by a slight white staining. Biopsies are then taken from these areas for further diagnosis.
The colposcopy itself and especially the colposcopic targeted biopsy of the cervix are painful. Virtual reality (VR) is a new method for 360° three-dimensional viewing of image content. A number of studies have shown that the use of VR can have a positive impact on the course of medical interventions. Randomized studies on the effectiveness of VR in a collective of women with colposcopically targeted biopsy of the cervix are not available according to a recent literature search (PubMed search of 12/30/2020; search terms: cervical biopsy, colposcopy, pain relief, pain control, virtual reality). In studies of our research group on colposcopy, we found increased pain scores especially in younger patients, but also in obese patients and smokers. A controlled study on the effectiveness of VR in colposcopically targeted biopsy is therefore useful.
In our study, we now want to answer the question under prospective conditions whether the use of VR before the start or before the start and during colposcopy compared to no intervention leads to a significant increase in patient satisfaction and/or a reduction in pain in the context of clarification colposcopy and colposcopically targeted biopsy.
Detailed description
HPV and cervical cancer
Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide. The prevalence in the population is high. Epidemiological estimates suggest that 75-80% of sexually active adults acquire an HPV infection in the genital area at least once by the age of 50. However, up to 95% of these HPV infections are considered harmless and are spontaneously eliminated within 2 years in terms of immunological HPV clearance [1]. On the other hand, persistent infections with HPV of the high-risk group, e.g. HPV-16 and HPV-18, are the main cause for the development of cervical carcinoma and are also partly responsible for the development of vulvar carcinoma, vaginal carcinoma and anal carcinoma. HPV preferentially infects the epithelial cells of the anogenital region and, through incorporation of HPV DNA into the host genome and subsequent interference with the cell cycle control of the host cell, causes changes in the cervical epithelium that, if left untreated, may develop into precancerous lesions (so-called cervical intraepithelial neoplasia) and consecutively into invasive carcinoma of the cervix (cervical carcinoma). Specifically, the viral protooncogene E6 gene product couples to p53 and promotes its degradation, and the viral protooncogene E7 gene product forms a complex with the retinoblastoma gene product pRB and suppresses its tumor suppressor function [2]. Both the impairment of apoptosis and tumor suppressor function promote immortalization of infected basal cells in the transformation zone of the cervix uteri.
Cervical carcinoma is the third most common cancer in women worldwide, as well as the fourth leading cause of death in women worldwide. Cervical carcinoma accounted for 9% (n=529 800) of all new cancer cases and 8% (n=275 100) of cancer-related deaths in women in 2008 [3].
The precursor of cervical cancer is cervical intraepithelial neoplasia (CIN), which can lead to the development of squamous cell carcinoma (approximately 80% of all cervical cancers). Three grades of expression are distinguished in CIN (CIN1, CIN 2, and CIN 3). Compared with invasive cervical carcinoma, the occurrence of precancerous lesions of the cervix uteri is more widespread. It is estimated that approximately 100,000 women in Germany develop new dysplasias (CIN 1-3) annually, with a point prevalence of >200,000 [3, 4].
Colposcopy as a diagnostic method
Dysplasia of the cervix typically becomes conspicuous during the gynecological screening examination at the gynecologist. In this case, smears are taken from the ectocervix and endocervix and assessed by the cytologist after a Papanicolaou stain has been performed with regard to dysplastic cells and the quality of the smear. For further clarification of dysplastic changes, presentation to a specialized dysplasia consultation is recommended. During colposcopic examination, histological confirmation of dysplastic areas is performed by means of biopsy.
Colposcopy (visual examination of the vagina and the entrance to the uterus with optical magnification) is an integral part of early cervical cancer detection. It is used to visualize dysplastic areas on the cervix uteri and to determine their spatial expression. The magnifying glass allows a multilevel (3.5 to 30x) two-dimensional magnification. After visual identification of suspicious areas using 5% acetic acid (dysplasias become acetic white) and classification into "minor" (grade 1) or "major" (grade 2) changes according to the internationally used RIO classification, a targeted biopsy for exact determination of the degree of dysplasia is possible [4]. Only in this way is further individual therapy planning possible.
Pain sensation during colposcopic examination.
Colposcopy itself and especially colposcopic targeted biopsy of the cervix are painful [4, 5]. General practice is to use local analgesics, oral analgesics, or no analgesics during a colposcopically targeted biopsy of the cervix [5]. The use of nonpharmacologic methods to positively influence patient pain perception and satisfaction has been investigated in a number of studies. For example, in a prospective randomized study, our group demonstrated that classical music (Mozart, Symphony No. 40 in G minor, KV 550) [6] had no positive influence on satisfaction and pain perception. Similarly, in another randomized study, we found no positive influence on satisfaction and pain perception by using video colposcopy [7]. Virtual reality (VR) is a new method for 360° three-dimensional viewing of image content. A number of studies have shown that the use of VR can have a positive effect on the course of medical interventions. For example, in a systematic review and meta-analysis of 8 randomized trials with a total of 723 subjects, Ding et al showed lower postoperative pain scores after the application of VR in the context of various surgeries such as dental, knee, hemorrhoid surgery, and obstetric injury care [8].
Randomized trials of the effectiveness of VR in a collective of women undergoing colposcopy-targeted cervical biopsy are not available according to a recent literature search (PubMed search as of 12/30/2020; search terms: cervical biopsy, colposcopy, pain relief, pain control, virtual reality). In studies of our research group on colposcopy, we found increased pain scores especially in younger patients, but also in obese patients and smokers [7, 9]. Therefore, a controlled study on the effectiveness of VR in colposcopy-targeted biopsy is reasonable.
Aim of the study
Our study now aims to answer the question under prospective conditions whether the use of VR before initiation or before initiation and during colposcopy compared to no intervention leads to a significant increase in patient satisfaction and/or a reduction in pain in the context of clarification colposcopy and colposcopically targeted biopsy.
References
- Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006;55:1-94.
- Münger K, Scheffner M, Huibregtse JM, Howley PM. Interactions of HPV E6 and E7 oncoproteins with tumour suppressor gene products. Cancer Surv. 1992;12:197-217.
- Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015;65:87-108. doi:10.3322/caac.21262.
- Kühn W. Kolposkopie zur Früherkennung des Zervixkarzinoms. Pathologe. 2011;32:497-504. doi:10.1007/s00292-011-1480-9.
- Heinrich J, Kühn W. Kolposkopie in Klinik und Praxis. 2nd ed. Berlin: De Gruyter; 2013.
- Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018;132:1047-55. doi:10.1097/AOG.0000000000002876.
- Hilal Z, Alici F, Tempfer CB, Seebacher V, Rezniczek GA. Video Colposcopy for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2017;130:411-9. doi:10.1097/AOG.0000000000002127.
- Ding L, Hua H, Zhu H, Zhu S, Lu J, Zhao K, Xu Q. Effects of virtual reality on relieving postoperative pain in surgical patients: A systematic review and meta-analysis. Int J Surg. 2020;82:87-94. doi:10.1016/j.ijsu.2020.08.033.
- Hilal Z, Rezniczek GA, Tettenborn Z, Hefler LA, Tempfer CB. Efficacy of Monsel Solution After Cervical Biopsy: A Randomized Trial. J Low Genit Tract Dis. 2016;20:312-6. doi:10.1097/LGT.0000000000000234.
- Laux L, Glanzmann P, Schaffner P, Spielberger CD. Das State-Trait-Angstinventar (STAI). Theoretische Grundlagen und Handlungsanweisungen. Weinheim: Beltz; 1981.
- Bornstein J, Bentley J, Bösze P, Girardi F, Haefner H, Menton M, et al. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol. 2012;120:166-72. doi:10.1097/AOG.0b013e318254f90c.
- Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377-81. doi:10.1016/j.jbi.2008.08.010.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective randomized open interventional study
| Arm | Type | Receives |
|---|---|---|
| Control Group (no VR) | No intervention | –Patients undergoing colposcopy and colposcopically-guided biopsy without further intervention |
| VR before and during colposcopy | Experimental | Device: Virtual reality headset before colposcopy, Device: Virtual reality headset during colposcopyPatients undergoing colposcopy and colposcopically-guided biopsy with a VR headset for 15 minutes before colposcopy as well as during colposcopy. |
| VR before colposcopy | Experimental | Device: Virtual reality headset before colposcopyPatients undergoing colposcopy and colposcopically-guided biopsy with a VR headset for 15 minutes before colposcopy but not during colposcopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written consent to participate in the study
- Clinically indicated colposcopy in case of abnormal PAP smear for detection of precancerous lesions of the cervix uteri and/or clinical abnormality of the cervix uteri (e.g. leukoplakia) with biopsy
Key exclusion criteria (3 listed)
- Eye diseases (e.g., glaucoma/cataracts) that impair viewing of VR content.
- Claustrophobia/agoraphobia or epilepsy
- Patients with insufficient knowledge of the German language
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 headset before colposcopyPatients wear a virtual headset presenting 360° 3D views of relaxing environments | Device | VR before and during colposcopy, VR before colposcopy |
| Virtual reality headset during colposcopyPatients wear a virtual headset presenting 360° 3D views of distracting environments | Device | VR before and during colposcopy |
Primary outcome
Patient satisfaction
Time frame: immediately after procedure
11-item VAS (0 = not satisfied at all, 10 = totally satisfied)
4 secondary outcomes
Patient pain
Time frame: during the colposcopy
Patient pain
Time frame: immediately after the colposcopy
Patient anxiety
Time frame: during the colposcopy
Surgical complications
Time frame: 72 hours after colposcopy
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 26 Apr 2024.
- Results publication: PubMed 37166026Hecken JM, Halagiera P, Rehman S, Tempfer CB, Rezniczek GA. Virtual Reality for Anxiety Reduction in Women Undergoing Colposcopy: A Randomized Controlled Trial. J Low Genit Tract Dis. 2023 Jul 1;27(3):223-229. doi: 10.1097/LGT.0000000000000745. Epub 2023 May 11.
- Individual participant dataSharing planned: No
Related trials for Cervical Dysplasia
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
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.
Clemens B Tempfer, MD study chair
Ruhr-Universität Bochum / Marien Hospital Herne
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 headset before colposcopy and Virtual reality headset during colposcopy in people with Cervical Dysplasia and Pain, run by Ruhr University of Bochum at 1 site in Germany.
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 2 inclusion and 3 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 26 Apr 2024. 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 Germany. 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?
Patient satisfaction (time frame: immediately after procedure). 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 NCT04751799, which also lists 1 linked publication.
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 26 Apr 2024.