Smear LayerPap-SmearNCT05662683
The Effect of Virtual Reality and Distraction Cards on Pain
A study testing Virtual Reality (VR), Distraction Cards Practice Group and Virtual Reality (VR) Breathing Exercise Group in people with Smear Layer and Cervical Cancer, run by Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate at 1 site in Turkey (Türkiye).
Trial summary
When the literature is examined, it is seen that virtual reality and distraction cards are used during medical procedures, and they have a reducing effect on pain perception and lowering the level of anxiety . 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
- Smear Layer, Cervical Cancer
- What is being tested?
- Virtual Reality (VR), Distraction Cards Practice Group and Virtual Reality (VR) Breathing Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 30 Jan 2023
- 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
- 30-65 years old, To see menstruation on the day of the operation, Turkish literate, No history of cervical surgery No active mental illness Did not use any pain or anxiety medication prior to the insertion procedure
Who cannot join
- Those with visual and auditory disabilities, Using misoprostol during the procedure, Using pain medication before the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
TurkishMoHKahramanmarasPH
Kahramanmaraş, 46050
About this study
Official title: The Effect of Virtual Reality and Distraction Cards on Pain, Anxiety and Satisfaction Levels of Women Who Have Pap-Smears
When the literature is examined, it is seen that virtual reality and distraction cards are used during medical procedures, and they have a reducing effect on pain perception and lowering the level of anxiety . On the other hand, no study has been found in the literature on the application of virtual glasses and distraction cards to women in the PAP-SMEAR process. However, in accordance with the results of the study conducted with the application of virtual reality glasses and distraction cards, it is thought that the application of virtual glasses will have a positive effect on reducing the perceived pain of women in the PAP-SMEAR process of distraction cards.
Read the detailed description
Cervical cancer is the fourth most common cancer worldwide. Cervical cancer is one of the most successfully treatable types of cancer, as long as it is detected early and managed effectively. WHO recommends the use of PAP-SMEAR and HPV DNA primary screening test to prevent cervical cancer in women. . The crude incidence of cervical cancer per 100,000 women in Turkey in 2020 is . WHO has targeted a threshold of 4 per 100,000 women by 2030 for countries to eliminate cervical cancer. To achieve this goal, 90% of girls should be vaccinated with HPV until the age of 15, and 70% of women should be screened with high performance PAP-SMEAR and HPV DNA at the age of 35 and 45 For this reason, it is seen that the PAP-SMEAR test has an important place in the protection of women's health. For the Pap-Smear test procedure, gynecological examination and speculum examination are included . Experiencing pain, anxiety, shyness and fear during gynecological examination are among the barriers to applying for and taking the pap-smear test, which has an important place in protecting women's health In the literature, it is seen that virtual reality glasses and distraction cards, which are cognitive behavioral techniques, are used during medical procedures and have a reducing effect on the perception of pain and reduce the level of anxiety . No study has been found that examines the effect on satisfaction and satisfaction levels. However, in line with the results of the study, it is thought that the PAP-SMEAR procedure will have a positive effect on women's perceived pain and anxiety, and increase their satisfaction levels. It emphasizes the need for cost-effective and feasible non-pharmacological methods by healthcare professionals during PAP-SMEAR application.
- Conditions
- Smear Layer, Cervical Cancer
- Being tested
- Virtual Reality (VR), Distraction Cards Practice Group, Virtual Reality (VR) Breathing Exercise Group
- Keywords
- Virtual Reality, Distraction Cards, Pain, Anxiety, pap-smear
- Medical subject headings
- Smear Layer, Uterine Cervical Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR)Other
Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. During the PAP-SMEAR application to be made with this device, watching a nature video with VR is within the framework of midwifery care applications and is not a treatment option for any treatment method, agent or disease. Although the video watched with VR has no effect on medical treatment and care within the framework of midwifery care, it does not have any harmful effects on women. The participant can withdraw from this study at any time without giving any reason.
Distraction Cards Practice GroupOther
It will take about 3-5 minutes to show the cards. The selection of the cards to be used is based on the cards suggested in the literature.
Virtual Reality (VR) Breathing Exercise GroupOther
From the preparation stage of the PAP-SMEAR ALDIRAN procedure to the completion of the application process that takes PAP-SMEAR, the virtual reality glasses for breathing exercise by clicking the youtube.com link (https://www.youtube.com/watch?v=Pddb09FAs68) after providing an internet connection with a smartphone for the image. will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Working Group 1 | Experimental | From the preparation stage of the PAP-SMEAR removal procedure to the completion of the PAP-SMEAR removal procedure until the completion of the PAP-SMEAR removal procedure, after providing an internet connection with a smartphone for the image, clicking the youtube.com link and watching Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video virtual reality Goggles will be provided.
Virtual reality glasses to be used in the research are not a medical device. Receives: Other: Virtual Reality (VR) |
| Working Group 2 | Experimental | Distraction cards containing five optical illusion figures will be shown to the women by the researcher Receives: Other: Distraction Cards Practice Group |
| Working Group 3 | Experimental | From the preparation stage of the PAP-SMEAR ALDIRAN procedure to the completion of the application process that takes PAP-SMEAR, the virtual reality glasses for breathing exercise by clicking the youtube.com link (https://www.youtube.com/watch?v=Pddb09FAs68) after providing an internet connection with a smartphone for the image. will be provided. Receives: Other: Virtual Reality (VR) Breathing Exercise Group |
| Control Group | No intervention | The maintenance and applications in the routine PAP-SMEAR application will be done exactly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Measured: (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.
Verbal Category Scale
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient's choice of the most appropriate word to describe the pain condition. Pain severity ranges from mild to unbearable. In this scale, he used the words "mild", "disturbing", "severe", "very severe", "unbearable" to describe the severity of pain (Annex-4). The individual is asked to choose the appropriate category for his situation.
Measured: before inspection pap smear
Verbal Category Scale
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient's choice of the most appropriate word to describe the pain condition. Pain severity ranges from mild to unbearable. In this scale, he used the words "mild", "disturbing", "severe", "very severe", "unbearable" to describe the severity of pain (Annex-4). The individual is asked to choose the appropriate category for his situation.
Measured: (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.
State Anxiety Scale
In the State Anxiety Scale; There are ten reversed statements, items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. When scoring, the reversed and direct statements are summed. Responses with a value of 4 indicate high anxiety in direct statements. In reversed expressions; Responses with a value of 1 indicate high anxiety, and responses with a value of 4 indicate low anxiety. The State Anxiety Scale score is calculated by adding 50 points to the difference between the total weighted scores of the reverse statements and the direct statements. Scoring in the State Anxiety Scale varies between 20-80 points. A score of less than 36 is considered no anxiety, a score of 37-42 is considered mild anxiety, and a score of 42 and above is considered high anxiety.
Measured: before PAP-SMEAR procedure
State Anxiety Scale
In the State Anxiety Scale; There are ten reversed statements, items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. When scoring, the reversed and direct statements are summed. Responses with a value of 4 indicate high anxiety in direct statements. In reversed expressions; Responses with a value of 1 indicate high anxiety, and responses with a value of 4 indicate low anxiety. The State Anxiety Scale score is calculated by adding 50 points to the difference between the total weighted scores of the reverse statements and the direct statements. Scoring in the State Anxiety Scale varies between 20-80 points. A score of less than 36 is considered no anxiety, a score of 37-42 is considered mild anxiety, and a score of 42 and above is considered high anxiety.
Measured: after PAP-SMEAR procedure
Newcastle Nursing Care Satisfaction Scale
The scale is a 5-point Likert-type scale consisting of 19 items including nursing care. All items of the Newcastle Nursing Care Satisfaction Scale are positive. In the scoring used to determine the degree of satisfaction, there are statements such as "Not at all Satisfied=1 point, Slightly Satisfied=2 points, Fairly Satisfied=3 points, Very Satisfied=4 points, Extremely Satisfied=5 points". The scores given to the questions of all items marked on the score evaluation scale are added together. The maximum score obtained from the scale is 95, and the minimum score is 19. Evaluation is made by converting the total score obtained from the scale to 100. The increase in the total score obtained from the scale indicates that the patients' satisfaction with nursing is high.
Measured: After PAP-SMEAR ALDIRAN procedure
Pulse Rate and Oxygen Saturation
The pulse rate and saturation values of women will be evaluated physiologically using the sensor compatible planet 50n LT model pulse oximeter (Nellcor COVIDIEN SPO 2) device
Measured: 20 minutes during pap smear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start20 Nov 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Smear LayerStudies 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
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mine Gokduman Keles, Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
- Investigators
- mine gökduman keleş, Midwifery, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662683
- Sponsor's protocol ID
- TurkishHKahramanmarasPH
- Acronym
- Pap-Smear
- Status last verified
- Jul 2024
- First submitted
- 15 Nov 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aktas D, Kumas MB, Odabasioglu BS, Kaya A. Effect of a Special Examination Gown and Nature-Based Sounds on Anxiety in Women Undergoing a Gynecological Examination. Clin Nurs Res. 2018 Jun;27(5):521-539. doi: 10.1177/1054773816686475. Epub 2017 Jan 8.
PubMed 28067068Angioli R, De Cicco Nardone C, Plotti F, Cafa EV, Dugo N, Damiani P, Ricciardi R, Linciano F, Terranova C. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):454-9. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17.
PubMed 23962572Ulker K, Kivrak Y. The Effect of Information About Gynecological Examination on the Anxiety Level of Women Applying to Gynecology Clinics: A Prospective, Randomized, Controlled Study. Iran Red Crescent Med J. 2016 Feb 6;18(6):e23864. doi: 10.5812/ircmj.23864. eCollection 2016 Jun.
PubMed 27621913Basak T, Duman S, Demirtas A. Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial. J Clin Nurs. 2020 Mar;29(5-6):770-777. doi: 10.1111/jocn.15131. Epub 2019 Dec 16.
PubMed 31793099Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.
PubMed 29025113Gur EY, Apay SE. The effect of cognitive behavioral techniques using virtual reality on birth pain: a randomized controlled trial. Midwifery. 2020 Dec;91:102856. doi: 10.1016/j.midw.2020.102856. Epub 2020 Sep 28.
PubMed 33478718Hylton J, Milton S, Sima AP, Karjane NW. Cold Compress for Intrauterine Device Insertional Pain: A Randomized Control Trial. Womens Health Rep (New Rochelle). 2020 Aug 4;1(1):227-231. doi: 10.1089/whr.2020.0056. eCollection 2020.
PubMed 33786484
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Distraction Cards on Pain, Anxiety and Satisfaction Levels of Women Who Have Pap-Smears
- ClinicalTrials.gov ID
- NCT05662683
- Acronym / sponsor ID
- Pap-Smear / TurkishHKahramanmarasPH
- Conditions
- Smear Layer, Cervical Cancer
- Keywords
- Virtual Reality, Distraction Cards, Pain, Anxiety, pap-smear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Turkish Ministry of Health, Kahramanmaras Provincial Health DirectorateOther government
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 22 Dec 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.
When the literature is examined, it is seen that virtual reality and distraction cards are used during medical procedures, and they have a reducing effect on pain perception and lowering the level of anxiety . On the other hand, no study has been found in the literature on the application of virtual glasses and distraction cards to women in the PAP-SMEAR process. However, in accordance with the results of the study conducted with the application of virtual reality glasses and distraction cards, it is thought that the application of virtual glasses will have a positive effect on reducing the perceived pain of women in the PAP-SMEAR process of distraction cards.
Detailed description
Cervical cancer is the fourth most common cancer worldwide. Cervical cancer is one of the most successfully treatable types of cancer, as long as it is detected early and managed effectively. WHO recommends the use of PAP-SMEAR and HPV DNA primary screening test to prevent cervical cancer in women. . The crude incidence of cervical cancer per 100,000 women in Turkey in 2020 is . WHO has targeted a threshold of 4 per 100,000 women by 2030 for countries to eliminate cervical cancer. To achieve this goal, 90% of girls should be vaccinated with HPV until the age of 15, and 70% of women should be screened with high performance PAP-SMEAR and HPV DNA at the age of 35 and 45 For this reason, it is seen that the PAP-SMEAR test has an important place in the protection of women's health. For the Pap-Smear test procedure, gynecological examination and speculum examination are included . Experiencing pain, anxiety, shyness and fear during gynecological examination are among the barriers to applying for and taking the pap-smear test, which has an important place in protecting women's health In the literature, it is seen that virtual reality glasses and distraction cards, which are cognitive behavioral techniques, are used during medical procedures and have a reducing effect on the perception of pain and reduce the level of anxiety . No study has been found that examines the effect on satisfaction and satisfaction levels. However, in line with the results of the study, it is thought that the PAP-SMEAR procedure will have a positive effect on women's perceived pain and anxiety, and increase their satisfaction levels. It emphasizes the need for cost-effective and feasible non-pharmacological methods by healthcare professionals during PAP-SMEAR application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Working Group 1 | Experimental | Other: Virtual Reality (VR)From the preparation stage of the PAP-SMEAR removal procedure to the completion of the PAP-SMEAR removal procedure until the completion of the PAP-SMEAR removal procedure, after providing an internet connection with a smartphone for the image, clicking the youtube.com link and watching Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video virtual reality Goggles will be provided. Virtual reality glasses to be used in the research are not a medical device. |
| Working Group 2 | Experimental | Other: Distraction Cards Practice GroupDistraction cards containing five optical illusion figures will be shown to the women by the researcher |
| Working Group 3 | Experimental | Other: Virtual Reality (VR) Breathing Exercise GroupFrom the preparation stage of the PAP-SMEAR ALDIRAN procedure to the completion of the application process that takes PAP-SMEAR, the virtual reality glasses for breathing exercise by clicking the youtube.com link (https://www.youtube.com/watch?v=Pddb09FAs68) after providing an internet connection with a smartphone for the image. will be provided. |
| Control Group | No intervention | –The maintenance and applications in the routine PAP-SMEAR application will be done exactly. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 30-65 years old, To see menstruation on the day of the operation, Turkish literate, No history of cervical surgery No active mental illness Did not use any pain or anxiety medication prior to the insertion procedure
Key exclusion criteria (1 listed)
- Those with visual and auditory disabilities, Using misoprostol during the procedure, Using pain medication before 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 (VR)Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. During the PAP-SMEAR application to be made with this device, watching a nature video with VR is within the framework of midwifery care applications and is not a treatment option for any treatment method, agent or disease. Although the video watched with VR has no effect on medical treatment and care within the framework of midwifery care, it does not have any harmful effects on women. The participant can withdraw from this study at any time without giving any reason. | Other | Working Group 1 |
| Distraction Cards Practice GroupIt will take about 3-5 minutes to show the cards. The selection of the cards to be used is based on the cards suggested in the literature. | Other | Working Group 2 |
| Virtual Reality (VR) Breathing Exercise GroupFrom the preparation stage of the PAP-SMEAR ALDIRAN procedure to the completion of the application process that takes PAP-SMEAR, the virtual reality glasses for breathing exercise by clicking the youtube.com link (https://www.youtube.com/watch?v=Pddb09FAs68) after providing an internet connection with a smartphone for the image. will be provided. | Other | Working Group 3 |
Primary outcome
Numerical Pain Rating Scale
Time frame: (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.
In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Verbal Category Scale
Time frame: before inspection pap smear
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient's choice of the most appropriate word to describe the pain condition. Pain severity ranges from mild to unbearable. In this scale, he used the words "mild", "disturbing", "severe", "very severe", "unbearable" to describe the severity of pain (Annex-4). The individual is asked to choose the appropriate category for his situation.
Verbal Category Scale
Time frame: (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient's choice of the most appropriate word to describe the pain condition. Pain severity ranges from mild to unbearable. In this scale, he used the words "mild", "disturbing", "severe", "very severe", "unbearable" to describe the severity of pain (Annex-4). The individual is asked to choose the appropriate category for his situation.
State Anxiety Scale
Time frame: before PAP-SMEAR procedure
In the State Anxiety Scale; There are ten reversed statements, items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. When scoring, the reversed and direct statements are summed. Responses with a value of 4 indicate high anxiety in direct statements. In reversed expressions; Responses with a value of 1 indicate high anxiety, and responses with a value of 4 indicate low anxiety. The State Anxiety Scale score is calculated by adding 50 points to the difference between the total weighted scores of the reverse statements and the direct statements. Scoring in the State Anxiety Scale varies between 20-80 points. A score of less than 36 is considered no anxiety, a score of 37-42 is considered mild anxiety, and a score of 42 and above is considered high anxiety.
State Anxiety Scale
Time frame: after PAP-SMEAR procedure
In the State Anxiety Scale; There are ten reversed statements, items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. When scoring, the reversed and direct statements are summed. Responses with a value of 4 indicate high anxiety in direct statements. In reversed expressions; Responses with a value of 1 indicate high anxiety, and responses with a value of 4 indicate low anxiety. The State Anxiety Scale score is calculated by adding 50 points to the difference between the total weighted scores of the reverse statements and the direct statements. Scoring in the State Anxiety Scale varies between 20-80 points. A score of less than 36 is considered no anxiety, a score of 37-42 is considered mild anxiety, and a score of 42 and above is considered high anxiety.
Newcastle Nursing Care Satisfaction Scale
Time frame: After PAP-SMEAR ALDIRAN procedure
The scale is a 5-point Likert-type scale consisting of 19 items including nursing care. All items of the Newcastle Nursing Care Satisfaction Scale are positive. In the scoring used to determine the degree of satisfaction, there are statements such as "Not at all Satisfied=1 point, Slightly Satisfied=2 points, Fairly Satisfied=3 points, Very Satisfied=4 points, Extremely Satisfied=5 points". The scores given to the questions of all items marked on the score evaluation scale are added together. The maximum score obtained from the scale is 95, and the minimum score is 19. Evaluation is made by converting the total score obtained from the scale to 100. The increase in the total score obtained from the scale indicates that the patients' satisfaction with nursing is high.
Pulse Rate and Oxygen Saturation
Time frame: 20 minutes during pap smear
The pulse rate and saturation values of women will be evaluated physiologically using the sensor compatible planet 50n LT model pulse oximeter (Nellcor COVIDIEN SPO 2) device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 28067068Aktas D, Kumas MB, Odabasioglu BS, Kaya A. Effect of a Special Examination Gown and Nature-Based Sounds on Anxiety in Women Undergoing a Gynecological Examination. Clin Nurs Res. 2018 Jun;27(5):521-539. doi: 10.1177/1054773816686475. Epub 2017 Jan 8.
- Background: PubMed 23962572Angioli R, De Cicco Nardone C, Plotti F, Cafa EV, Dugo N, Damiani P, Ricciardi R, Linciano F, Terranova C. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):454-9. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17.
- Background: PubMed 27621913Ulker K, Kivrak Y. The Effect of Information About Gynecological Examination on the Anxiety Level of Women Applying to Gynecology Clinics: A Prospective, Randomized, Controlled Study. Iran Red Crescent Med J. 2016 Feb 6;18(6):e23864. doi: 10.5812/ircmj.23864. eCollection 2016 Jun.
- Background: PubMed 31793099Basak T, Duman S, Demirtas A. Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial. J Clin Nurs. 2020 Mar;29(5-6):770-777. doi: 10.1111/jocn.15131. Epub 2019 Dec 16.
- Background: PubMed 29025113Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.
- Background: PubMed 33478718Gur EY, Apay SE. The effect of cognitive behavioral techniques using virtual reality on birth pain: a randomized controlled trial. Midwifery. 2020 Dec;91:102856. doi: 10.1016/j.midw.2020.102856. Epub 2020 Sep 28.
- Background: PubMed 33786484Hylton J, Milton S, Sima AP, Karjane NW. Cold Compress for Intrauterine Device Insertional Pain: A Randomized Control Trial. Womens Health Rep (New Rochelle). 2020 Aug 4;1(1):227-231. doi: 10.1089/whr.2020.0056. eCollection 2020.
- WHO. Cervical Cancer Country Profiles. 2021.Link provided by the sponsor.
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.
mine gökduman keleş, Midwifery principal investigator
Ministry of Health
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 (VR), Distraction Cards Practice Group and Virtual Reality (VR) Breathing Exercise Group in people with Smear Layer and Cervical Cancer, run by Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate 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 1 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 9 Jul 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 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 Rating Scale (time frame: (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.). The study lists 7 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 NCT05662683, which also lists 7 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 9 Jul 2024.