AnxietyNCT05895188
The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction
A study testing Virtual Reality Glasses in people with Anxiety and Pain, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
This research is a randomized controlled experimental study designed to determine the effect of video, which is watched by virtual reality glasses during the procedure, on anxiety, pain and patient satisfaction to women who have had pap smear test. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Patient Satisfaction
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2022to 1 Jan 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
- Being in the age range of 30-65,
- To have Pap Smear test for the first time,
- Speaking Turkish and reading and writing,
- No vision and hearing problems,
- Not using glasses,
- Not a diagnosed psychiatric disease.
Who cannot join
- Having any physical or mental problems that may prevent communication
- To have a Pap Smear test before.
- Removing virtual reality glasses during the process
- Not filling the post -test form after the procedure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Düzce General Directorate of Public Health Cancer Early Diagnosis Screening and Training Center
Düzce, Merkez, 81010
Ökkeş Kepek, Dr., (0380) 514 80 00, duzce@saglik.gov.tr
About this study
Official title: The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction: A Randomized Controlled Trial
This research is a randomized controlled experimental study designed to determine the effect of video, which is watched by virtual reality glasses during the procedure, on anxiety, pain and patient satisfaction to women who have had pap smear test.
Read the detailed description
Cervical cancer is the most important preventable gynecological cancer that can be diagnosed with early screening among female gynecological cancers. Today, cervical cancer has become an important public health problem (General Directorate of Public According to the data of the Global Cancer Observatory (GLOBOCAN), a subsidiary of the World Health Organization, 604,127 women were diagnosed with cervical cancer in 2020. With these new cases, cervical cancer ranked 4th worldwide in incidence and mortality. In Turkey, the incidence of cervical cancer ranks 3rd among gynecological cancers. In the world and in Turkey. The primary prevention of this cancer type, which has a high mortality rate in addition to its incidence rate, is the Human Papilloma Virus (HPV) vaccine. Secondary prevention includes early diagnosis with screening tests. Screening tests for the diagnosis of cervical cancer are pap smear test and HPV DNA test.
Thanks to the Pap smear screening test, the diagnosis can be made even if cervical cancer does not show any symptoms. In addition, preinvasive and invasive lesions of cervical cancer can be detected. Thanks to these features of the Pap smear test, lesions can be detected in the early period, the treatment process can be started early, and mortality and morbidity rates can be reduced. The Pap smear test is an easy-to-apply, inexpensive, reliable and easy-to-access screening test. It has been reported that regular pap smear test screening reduces the mortality and morbidity rate of cervical cancer by 70% in developed countries. It is recommended by the Ministry of Health that women over the age of 30 should have a pap smear test once every 5 years. It is recommended that screening be discontinued in women who have 3 consecutive negative tests or who are over 65 years old. Despite the recommendations and practices of the Ministry of Health, 20% of women in Turkey were screened within the scope of the screening program. Studies conducted in the national and international literature reveal many reasons why women do not have a pap smear test.
The primary reason why women do not have a pap smear test is gynecological examination. Women may experience anxiety and worry due to the speculum used during the gynecological examination, the fact that the procedure area is a private area, and the possibility of being diagnosed with cancer as a result of the test. In a study, it was found that 20.7% of women experienced moderate anxiety and 10.9% had high level anxiety before the gynecological examination. In another study, the state anxiety score of women who applied for a pap smear test was found to be high. Women may develop negative attitudes towards screening tests due to the anxiety they experience. For this reason, early diagnosis may miss the opportunity. Özcan et al. recommend that nurses provide supportive care to women during gynecological examination and reduce their anxiety.
Distraction method and pain and anxiety management are among the independent roles of nurses. There are many nursing practices that can be done to reduce the anxiety and pain feelings of patients. Virtual reality application is also used as one of these applications. With the developing technology, virtual reality applications have started to be applied as a distraction technique. Created as a result of combining three-dimensional and interactive graphics prepared in virtual reality computer environments with various programs in the computer environment, it has been defined as technologies that draw users directly into a virtual world and create the feeling of being in the real world. The sensors placed in the virtual reality glasses detect the head movements of the user and act in sync with the virtual environment, allowing the individual to see the place where the individual turns his head in the virtual environment. Thanks to this feature of virtual reality glasses, people can make nature, underwater and museum tours. Virtual reality glasses create a feeling of being in a virtual environment. Thus, the person can completely move away from the environment. This feature of virtual reality applications is mostly used in the medical field. People are moving away from the medical environment they are in, they feel as if they are in the images being watched. In this way, their attention can be diverted and their anxiety levels can be reduced. As people focus on the images they see, pain signals reach the brain later and there is a decrease in pain sensation. Anxiety and pain can be reduced with virtual reality application during invasive procedures such as hysteroscopy, amniocentesis, curettage, embryo transfer. reduction studies have been carried out. In the study of Deo et al., qualitative interviews were conducted at the end of the virtual reality application. 85% of the participants stated that the virtual reality application removed them from the examination environment, thus they felt less pain and their anxiety decreased.
Studies using virtual reality during gynecological and obstetric diagnosis and treatment procedures have been found in the literature. In the available literature, no study has been found in which virtual reality is applied to women who will undergo pap smear test. With this study, it was aimed to increase patient satisfaction by reducing the pain and anxiety experienced during the pap smear screening test. In addition to this purpose, this study is important in terms of showing that virtual reality application, which is a product of developing technology, is adaptable and applicable to nursing care. It is thought that the health worker can also apply the procedure more easily, thanks to the reduction and relaxation of the anxiety of the woman during the procedure. As a result of the study, it is thought that if the pain and anxiety levels of women are reduced, the rates of having pap smear screening test will increase in the long run. In the study of Marashi et al., negative experiences during the first test were shown as one of the reasons why women did not have a pap smear test. It is thought that the negative experiences of women will be minimized by reducing the level of pain and anxiety. It is thought that the results of the research will contribute to the current literature.
- Conditions
- Anxiety, Pain, Patient Satisfaction
- Being tested
- Virtual Reality Glasses
- Keywords
- Papanicolaou Test, Virtual Reality
- Medical subject headings
- Anxiety Disorders, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesDevice
From the beginning to the end of the procedure, women will watch the selected nature video.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Before starting the process, participants will be informed about the study and their verbal and written consent will be obtained. Participants in the virtual reality group will be shown and introduced to virtual reality glasses before the procedure. After the woman goes to the examination table and takes the appropriate position for the pap smear procedure, virtual reality glasses will be put on the woman by the researcher. The selected video will be played until the Pap smear process is completed. (https://www.youtube.com/watch?v=6ud18oSuCiY\&t=30s). When the Pap smear is finished, the glasses will be removed and the woman will be helped to get up from the examination table. In this process, no form will be filled until the participant woman gets dressed and takes the ready position. Thus, the privacy of women will be protected and there will be no violation of ethical rights. Receives: Device: Virtual Reality Glasses |
| Control Group | No intervention | Verbal and written consent will be obtained from the participants before starting the procedure. No intervention will be applied to the participants in the control group. The forms that need to be filled before the procedure will be filled. With the help and guidance of the researcher, the woman will prepare, move to the examination table and take a position. After the Pap smear process is over, the participant woman will get off the examination table with the help of the researcher and get dressed. After the woman is ready after the procedure, she will go to the waiting room and fill out the forms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level
Anxiety will be measured with the Visual Analog Scale (VAS-Anxiety). The Anxiety Visual Analog Scale includes numbers from 0 to 10, the higher the number marked, the higher the level of anxiety felt.Anxiety level will be measured twice, before and after the procedure.
Measured: 15 minutes
State Anxiety Level
Anxiety level after the procedure will be measured with the State Anxiety Inventory (STAI I). The state anxiety scale measures the level of anxiety felt at the moment. It consists of 20 items, scores range from 20-80. The higher the score, the higher the level of anxiety felt. state anxiety level will be measured once after the pap smear process is completed.
Measured: 15 minutes
Secondary outcomes (3)
Pain Level
It will be measured with the Visual Analog Scale (VAS). The visual analog scale includes numbers 1-10, as the marked number increases, the level of pain felt increases.
Measured: 15 minutes
patient satisfaction level
It will be measured by the evaluation form of numerical patient satisfaction. It is formed in a single -item likert type. It is scored between 1-5 points. As the score increases, the level of satisfaction for the Pap Smear test increases.
Measured: 15 minutes
virtual reality application satisfaction level
Satisfaction with Virtual Reality will be measured with the Evaluation Form. It was created in a 5-point likert type. It consists of 12 items. The highest satisfaction score is 40 points because it also includes negative statements. As the score increases in the range of 40-75 points, satisfaction decreases.
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 posted8 Jun 2023
- Study start12 Dec 2022
- Primary completion17 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Model description
- In the study, there are two groups, the virtual reality group in which virtual reality glasses were applied and the control group, which did not apply any intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Gülen Savaş, Duzce University
- Investigators
- Hacer GÜLEN SAVAŞ, PhD, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895188
- Sponsor's protocol ID
- DU-SBF-RS-01
- Status last verified
- May 2023
- First submitted
- 10 Dec 2022
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05895188
- Acronym / sponsor ID
- DU-SBF-RS-01
- Conditions
- Anxiety, Pain, Patient Satisfaction
- Keywords
- Papanicolaou Test, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 17 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 8 Jun 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.
This research is a randomized controlled experimental study designed to determine the effect of video, which is watched by virtual reality glasses during the procedure, on anxiety, pain and patient satisfaction to women who have had pap smear test.
Detailed description
Cervical cancer is the most important preventable gynecological cancer that can be diagnosed with early screening among female gynecological cancers. Today, cervical cancer has become an important public health problem (General Directorate of Public According to the data of the Global Cancer Observatory (GLOBOCAN), a subsidiary of the World Health Organization, 604,127 women were diagnosed with cervical cancer in 2020. With these new cases, cervical cancer ranked 4th worldwide in incidence and mortality. In Turkey, the incidence of cervical cancer ranks 3rd among gynecological cancers. In the world and in Turkey. The primary prevention of this cancer type, which has a high mortality rate in addition to its incidence rate, is the Human Papilloma Virus (HPV) vaccine. Secondary prevention includes early diagnosis with screening tests. Screening tests for the diagnosis of cervical cancer are pap smear test and HPV DNA test.
Thanks to the Pap smear screening test, the diagnosis can be made even if cervical cancer does not show any symptoms. In addition, preinvasive and invasive lesions of cervical cancer can be detected. Thanks to these features of the Pap smear test, lesions can be detected in the early period, the treatment process can be started early, and mortality and morbidity rates can be reduced. The Pap smear test is an easy-to-apply, inexpensive, reliable and easy-to-access screening test. It has been reported that regular pap smear test screening reduces the mortality and morbidity rate of cervical cancer by 70% in developed countries. It is recommended by the Ministry of Health that women over the age of 30 should have a pap smear test once every 5 years. It is recommended that screening be discontinued in women who have 3 consecutive negative tests or who are over 65 years old. Despite the recommendations and practices of the Ministry of Health, 20% of women in Turkey were screened within the scope of the screening program. Studies conducted in the national and international literature reveal many reasons why women do not have a pap smear test.
The primary reason why women do not have a pap smear test is gynecological examination. Women may experience anxiety and worry due to the speculum used during the gynecological examination, the fact that the procedure area is a private area, and the possibility of being diagnosed with cancer as a result of the test. In a study, it was found that 20.7% of women experienced moderate anxiety and 10.9% had high level anxiety before the gynecological examination. In another study, the state anxiety score of women who applied for a pap smear test was found to be high. Women may develop negative attitudes towards screening tests due to the anxiety they experience. For this reason, early diagnosis may miss the opportunity. Özcan et al. recommend that nurses provide supportive care to women during gynecological examination and reduce their anxiety.
Distraction method and pain and anxiety management are among the independent roles of nurses. There are many nursing practices that can be done to reduce the anxiety and pain feelings of patients. Virtual reality application is also used as one of these applications. With the developing technology, virtual reality applications have started to be applied as a distraction technique. Created as a result of combining three-dimensional and interactive graphics prepared in virtual reality computer environments with various programs in the computer environment, it has been defined as technologies that draw users directly into a virtual world and create the feeling of being in the real world. The sensors placed in the virtual reality glasses detect the head movements of the user and act in sync with the virtual environment, allowing the individual to see the place where the individual turns his head in the virtual environment. Thanks to this feature of virtual reality glasses, people can make nature, underwater and museum tours. Virtual reality glasses create a feeling of being in a virtual environment. Thus, the person can completely move away from the environment. This feature of virtual reality applications is mostly used in the medical field. People are moving away from the medical environment they are in, they feel as if they are in the images being watched. In this way, their attention can be diverted and their anxiety levels can be reduced. As people focus on the images they see, pain signals reach the brain later and there is a decrease in pain sensation. Anxiety and pain can be reduced with virtual reality application during invasive procedures such as hysteroscopy, amniocentesis, curettage, embryo transfer. reduction studies have been carried out. In the study of Deo et al., qualitative interviews were conducted at the end of the virtual reality application. 85% of the participants stated that the virtual reality application removed them from the examination environment, thus they felt less pain and their anxiety decreased.
Studies using virtual reality during gynecological and obstetric diagnosis and treatment procedures have been found in the literature. In the available literature, no study has been found in which virtual reality is applied to women who will undergo pap smear test. With this study, it was aimed to increase patient satisfaction by reducing the pain and anxiety experienced during the pap smear screening test. In addition to this purpose, this study is important in terms of showing that virtual reality application, which is a product of developing technology, is adaptable and applicable to nursing care. It is thought that the health worker can also apply the procedure more easily, thanks to the reduction and relaxation of the anxiety of the woman during the procedure. As a result of the study, it is thought that if the pain and anxiety levels of women are reduced, the rates of having pap smear screening test will increase in the long run. In the study of Marashi et al., negative experiences during the first test were shown as one of the reasons why women did not have a pap smear test. It is thought that the negative experiences of women will be minimized by reducing the level of pain and anxiety. It is thought that the results of the research will contribute to the current literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In the study, there are two groups, the virtual reality group in which virtual reality glasses were applied and the control group, which did not apply any intervention.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality GlassesBefore starting the process, participants will be informed about the study and their verbal and written consent will be obtained. Participants in the virtual reality group will be shown and introduced to virtual reality glasses before the procedure. After the woman goes to the examination table and takes the appropriate position for the pap smear procedure, virtual reality glasses will be put on the woman by the researcher. The selected video will be played until the Pap smear process is completed. (https://www.youtube.com/watch?v=6ud18oSuCiY\&t=30s). When the Pap smear is finished, the glasses will be removed and the woman will be helped to get up from the examination table. In this process, no form will be filled until the participant woman gets dressed and takes the ready position. Thus, the privacy of women will be protected and there will be no violation of ethical rights. |
| Control Group | No intervention | –Verbal and written consent will be obtained from the participants before starting the procedure. No intervention will be applied to the participants in the control group. The forms that need to be filled before the procedure will be filled. With the help and guidance of the researcher, the woman will prepare, move to the examination table and take a position. After the Pap smear process is over, the participant woman will get off the examination table with the help of the researcher and get dressed. After the woman is ready after the procedure, she will go to the waiting room and fill out the forms. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A sufficient level of education to understand study procedures and be able to communicate with site personnel
- Being in the age range of 30-65,
- To have Pap Smear test for the first time,
- Speaking Turkish and reading and writing,
- No vision and hearing problems,
Key exclusion criteria (4 listed)
- Having any physical or mental problems that may prevent communication
- To have a Pap Smear test before.
- Removing virtual reality glasses during the process
- Not filling the post -test form after the procedure.
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 GlassesFrom the beginning to the end of the procedure, women will watch the selected nature video. | Device | Virtual Reality Group |
Primary outcome
Anxiety Level
Time frame: 15 minutes
Anxiety will be measured with the Visual Analog Scale (VAS-Anxiety). The Anxiety Visual Analog Scale includes numbers from 0 to 10, the higher the number marked, the higher the level of anxiety felt.Anxiety level will be measured twice, before and after the procedure.
State Anxiety Level
Time frame: 15 minutes
Anxiety level after the procedure will be measured with the State Anxiety Inventory (STAI I). The state anxiety scale measures the level of anxiety felt at the moment. It consists of 20 items, scores range from 20-80. The higher the score, the higher the level of anxiety felt. state anxiety level will be measured once after the pap smear process is completed.
3 secondary outcomes
Pain Level
Time frame: 15 minutes
patient satisfaction level
Time frame: 15 minutes
virtual reality application satisfaction level
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Hacer GÜLEN SAVAŞ, PhD principal investigator
Duzce 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 Glasses in people with Anxiety and Pain, run by Duzce 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer GÜLEN SAVAŞ, PhD (0850 800 81 81 ext. 3506, hacergulen@duzce.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: 15 minutes). 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 8 Jun 2023.