Virtual RealityVirtualNCT05655052
The Effect of Virtual Reality Glasses Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'
A study testing Virtual Reality (VR) Group and Group using distraction cards in people with Virtual Reality and Pain, run by Mine Gokduman Keles at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of virtual reality glasses and distraction cards, which are cognitive behavioral techniques, on women's pain, anxiety and satisfaction levels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Pain, Anxiety
- What is being tested?
- Virtual Reality (VR) Group and Group using distraction cards
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 30 Jun 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18-45,
- IUD applied,
Who cannot join
- Having visual and auditory disabilities,
- Use of misoprostol during the procedure,
- Pre-procedure pain medication use,
- Pre-procedure anxiety medication use.
Trial locations and contacts
1 site in 1 country.
Eylem Toker contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
TurkishMoHKahramanmarasPH
Kahramanmaraş, 46050
mine KELEŞ, 5055624560, minegkdmn@hotmail.com
About this study
Official title: The Effect of Virtual Reality Glasses and Distraction Cards on Women's Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'
The aim of this study is to examine the effects of virtual reality glasses and distraction cards, which are cognitive behavioral techniques, on women's pain, anxiety and satisfaction levels. It is aimed to reduce your anxiety level, reduce pain level and increase feelings of satisfaction by showing you a nature video with Virtual Reality Glasses or showing distraction cards so that you can spend this process more comfortably while IUD is being applied. The following questions are expected to be answered in this research: When virtual reality glasses and distraction cards are applied during the IUD procedure; (1) Does it affect the woman's pain level? (2) Does it affect the woman's anxiety level? (3) does it have an effect on women's satisfaction? In addition, it is aimed to reveal the effectiveness of virtual reality glasses and distraction cards in the IUD application process, which is one of the modern family planning methods in midwifery applications, and to bring a non-invasive and cost-effective option into practice.
Read the detailed description
The proportion of women who want to use Family Planning in the world in the last two decades has reached approximately 1.1 billion and has shown a significant increase . Despite this increasing demand, it is seen that there has been a slow increase of 3.2 in the ratio of family planning (FP) needs met by modern contraceptive methods for women of reproductive age in the last ten years. The reasons for this slow increase include limited access to modern contraceptive methods, women's prejudice about some methods, and low quality of available services . In addition, WHO reported that almost half of pregnancies in developing countries between 2015 and 2019 were unwanted pregnancies , and recommended effective FP counseling and the use of more modern contraceptive methods to prevent this . In Turkey, the Ministry of Health provides individuals with free access to modern FP methods. Despite this, according to 2018 data of the Turkey Demographic and Health Survey (TNSA), it has been reported that 49% use modern methods in the use of FP method, and the Intrauterine Device (IUD) is among the most effective modern methods with a rate of 14% . Among the factors affecting the use of the IUD; women's perception of pain during the application and the fact that it can be applied in certain centers .
In addition, it has been reported in the literature that women perceive pain during IUD application. In these studies, pain; especially used in the stages of IUD application; It is reported that it is detected during tenaculum insertion, measurement with a hysterometer, and finally during IUD insertion. For this reason, there is a need for applications to reduce the pain associated with the IUD application, which is the modern FP method of women. Again, it is assumed that women will experience anxiety before the IUD application as in other medical procedures . It is seen in the literature that there are studies to alleviate the perceived pain in IUD application . In addition, it is expected that the applications made to women for the symptoms such as pain and anxiety related to the applications in the field of health will increase their satisfaction . In this context, there are studies in the literature showing that virtual reality glasses and distraction cards, which are cognitive behavioral techniques, are used during medical procedures, reducing the perception of pain and reducing the level of anxiety. . Although virtual reality glasses are a technological device, they have been widely used in the medical field in hospitals. 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. The applications to be made with this device are within the framework of midwifery care applications and are not a treatment method, mediator or treatment option for any disease and do not have any harmful effects. Again, the cards with optical illusion figures on the distraction cards enable women to focus and reduce pain and anxiety.
No study has been found in the literature examining the effects of virtual reality glasses and distraction techniques on pain, anxiety and satisfaction levels in IUD application. However, in line with the results of the study, it is thought that the IUD procedure will have a positive effect on reducing the perceived pain and anxiety of women and increase satisfaction.
- Conditions
- Virtual Reality, Pain, Anxiety, Distraction Cards
- Being tested
- Virtual Reality (VR) Group, Group using distraction cards
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) GroupDevice
At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.
- An introductory information form will be filled in for women in all three groups.
- While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
- Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
- The Control Group will be given routine IUD application and care.
Group using distraction cardsDevice
At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.
- An introductory information form will be filled in for women in all three groups.
- While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
- Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
- The Control Group will be given routine IUD application and care.
| Study group | Role | What they receive |
|---|---|---|
| working grup 1: Virtual Reality (VR) Group | Experimental | From the preparation stage of the IUD until the IUD application process is completed, after the internet connection is provided with a smart phone for the image, by clicking on the youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video will be provided and virtual reality glasses will be provided.
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. The practice of watching nature videos with VR during the IUD application with this device is within the framework of midwifery care practices and is not a treatment option for any treatment method, tool 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. Receives: Device: Virtual Reality (VR) Group |
| Working Group 2: Distraction Cards Implementation Group | Experimental | From the preparation stage of the IUD procedure to the completion of the IUD application process, distraction cards containing five optical illusion figures, one of the distraction techniques, will be shown to the women by the researcher . Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns are such that individuals can only see when they look carefully. During the process, the women will focus on the cards and be distracted by asking what they see on the cards by communicating face-to-face with the researcher women about the pictures and shapes they see on the cards. Thus, it is thought that the cards with optical figures on the distraction cards will enable women to focus and reduce pain and anxiety. Display of cards will take approximately 3-5 minutes Receives: Device: Group using distraction cards |
| Control Group | No intervention | Unlike the study group, women included in the control group will not only be shown video watching applications with virtual glasses and distraction cards. The maintenance and applications in the routine IUD application will be done exactly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: ria application restriction averages 20 minutes
Verbal Category (SKO)
Verbal Category Scale (SCA) (Appendix 4): 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 (Appendix-5). The individual is asked to choose the appropriate category for his situation.
Measured: Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
Numerical Pain Rating Scale (SAAS)
Numerical pain rating scale (SARS) is used to evaluate pain severity. In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Measured: Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
State Anxiety Scale (STAI TX-I)
items are answered by marking one of the options such as (1) none, (2) a little, (3) a lot, (4) a lot, depending on the severity of the emotion or behavior. There are two types of expressions in the scale. These are reversed or straight forward expressions. reversed expressions; positive emotions express, while direct expressions express negative emotions. When scoring reverse expressions, those with a weight of 1 are converted to 4, and those with a weight of 4 are converted to 1. 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. ints.
Measured: Before and after IUD procedure
Newcastle Nursing Care Satisfaction Scale (NHMS)
The scale is a 5-point Likert-type scale consisting of 19 items covering 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.
Measured: ria application restriction averages 20 minutes
Virtual Reality Glasses Application Question
Virtual Reality Glasses Application Question,It was created by scanning the literature by the researcher.
Measured: ria application restriction averages 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start15 Nov 2022
- Primary completion30 Dec 2022
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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
- : A randomized controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mine Gokduman Keles
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mine Gokduman Keles, Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655052
- Sponsor's protocol ID
- TurkishMoHKahramanmaras
- Acronym
- Virtual
- Status last verified
- Apr 2023
- First submitted
- 15 Nov 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007 Jun;75(6 Suppl):S55-9. doi: 10.1016/j.contraception.2006.12.004. Epub 2007 Feb 16.
PubMed 17531618Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.
PubMed 29079143Gemzell-Danielsson K, Jensen JT, Monteiro I, Peers T, Rodriguez M, Di Spiezio Sardo A, Bahamondes L. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019 Dec;98(12):1500-1513. doi: 10.1111/aogs.13662. Epub 2019 Jun 27.
PubMed 31112295Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019 Jun;24(3):240-245. doi: 10.1080/13625187.2019.1610872. Epub 2019 May 16.
PubMed 31094575Hylton 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 33786484Toker E, Gokduman Keles M. The Impact of Virtual Reality with Relaxation Music and Distraction Cards on Pain, Anxiety, and Satisfaction Levels of Women with an Intrauterine Device: A Randomized Controlled Trial. J Midwifery Womens Health. 2026 Jan-Feb;71(1):104-112. doi: 10.1111/jmwh.70048. Epub 2025 Nov 14.
PubMed 41235692
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses and Distraction Cards on Women's Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'
- ClinicalTrials.gov ID
- NCT05655052
- Acronym / sponsor ID
- Virtual / TurkishMoHKahramanmaras
- Conditions
- Virtual Reality, Pain, Anxiety, Distraction Cards
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Mine Gokduman KelesOther government
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 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.
The aim of this study is to examine the effects of virtual reality glasses and distraction cards, which are cognitive behavioral techniques, on women's pain, anxiety and satisfaction levels. It is aimed to reduce your anxiety level, reduce pain level and increase feelings of satisfaction by showing you a nature video with Virtual Reality Glasses or showing distraction cards so that you can spend this process more comfortably while IUD is being applied. The following questions are expected to be answered in this research: When virtual reality glasses and distraction cards are applied during the IUD procedure; (1) Does it affect the woman's pain level? (2) Does it affect the woman's anxiety level? (3) does it have an effect on women's satisfaction? In addition, it is aimed to reveal the effectiveness of virtual reality glasses and distraction cards in the IUD application process, which is one of the modern family planning methods in midwifery applications, and to bring a non-invasive and cost-effective option into practice.
Detailed description
The proportion of women who want to use Family Planning in the world in the last two decades has reached approximately 1.1 billion and has shown a significant increase . Despite this increasing demand, it is seen that there has been a slow increase of 3.2 in the ratio of family planning (FP) needs met by modern contraceptive methods for women of reproductive age in the last ten years. The reasons for this slow increase include limited access to modern contraceptive methods, women's prejudice about some methods, and low quality of available services . In addition, WHO reported that almost half of pregnancies in developing countries between 2015 and 2019 were unwanted pregnancies , and recommended effective FP counseling and the use of more modern contraceptive methods to prevent this . In Turkey, the Ministry of Health provides individuals with free access to modern FP methods. Despite this, according to 2018 data of the Turkey Demographic and Health Survey (TNSA), it has been reported that 49% use modern methods in the use of FP method, and the Intrauterine Device (IUD) is among the most effective modern methods with a rate of 14% . Among the factors affecting the use of the IUD; women's perception of pain during the application and the fact that it can be applied in certain centers .
In addition, it has been reported in the literature that women perceive pain during IUD application. In these studies, pain; especially used in the stages of IUD application; It is reported that it is detected during tenaculum insertion, measurement with a hysterometer, and finally during IUD insertion. For this reason, there is a need for applications to reduce the pain associated with the IUD application, which is the modern FP method of women. Again, it is assumed that women will experience anxiety before the IUD application as in other medical procedures . It is seen in the literature that there are studies to alleviate the perceived pain in IUD application . In addition, it is expected that the applications made to women for the symptoms such as pain and anxiety related to the applications in the field of health will increase their satisfaction . In this context, there are studies in the literature showing that virtual reality glasses and distraction cards, which are cognitive behavioral techniques, are used during medical procedures, reducing the perception of pain and reducing the level of anxiety. . Although virtual reality glasses are a technological device, they have been widely used in the medical field in hospitals. 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. The applications to be made with this device are within the framework of midwifery care applications and are not a treatment method, mediator or treatment option for any disease and do not have any harmful effects. Again, the cards with optical illusion figures on the distraction cards enable women to focus and reduce pain and anxiety.
No study has been found in the literature examining the effects of virtual reality glasses and distraction techniques on pain, anxiety and satisfaction levels in IUD application. However, in line with the results of the study, it is thought that the IUD procedure will have a positive effect on reducing the perceived pain and anxiety of women and increase satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- : A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| working grup 1: Virtual Reality (VR) Group | Experimental | Device: Virtual Reality (VR) GroupFrom the preparation stage of the IUD until the IUD application process is completed, after the internet connection is provided with a smart phone for the image, by clicking on the youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video will be provided and virtual reality glasses will be provided. 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. The practice of watching nature videos with VR during the IUD application with this device is within the framework of midwifery care practices and is not a treatment option for any treatment method, tool 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. |
| Working Group 2: Distraction Cards Implementation Group | Experimental | Device: Group using distraction cardsFrom the preparation stage of the IUD procedure to the completion of the IUD application process, distraction cards containing five optical illusion figures, one of the distraction techniques, will be shown to the women by the researcher . Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns are such that individuals can only see when they look carefully. During the process, the women will focus on the cards and be distracted by asking what they see on the cards by communicating face-to-face with the researcher women about the pictures and shapes they see on the cards. Thus, it is thought that the cards with optical figures on the distraction cards will enable women to focus and reduce pain and anxiety. Display of cards will take approximately 3-5 minutes |
| Control Group | No intervention | –Unlike the study group, women included in the control group will not only be shown video watching applications with virtual glasses and distraction cards. The maintenance and applications in the routine IUD application will be done exactly. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- between the ages of 18-45,
- IUD applied,
Key exclusion criteria (4 listed)
- Having visual and auditory disabilities,
- Use of misoprostol during the procedure,
- Pre-procedure pain medication use,
- Pre-procedure anxiety medication use.
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) GroupAt the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study. * An introductory information form will be filled in for women in all three groups. * While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses. * Distraction Cards will be shown while the Intervention Group 2 IUD is being administered. * The Control Group will be given routine IUD application and care. | Device | working grup 1: Virtual Reality (VR) Group |
| Group using distraction cardsAt the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study. * An introductory information form will be filled in for women in all three groups. * While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses. * Distraction Cards will be shown while the Intervention Group 2 IUD is being administered. * The Control Group will be given routine IUD application and care. | Device | Working Group 2: Distraction Cards Implementation Group |
Primary outcome
Pulse Rate and Oxygen Saturation
Time frame: ria application restriction averages 20 minutes
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.
Verbal Category (SKO)
Time frame: Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
Verbal Category Scale (SCA) (Appendix 4): 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 (Appendix-5). The individual is asked to choose the appropriate category for his situation.
Numerical Pain Rating Scale (SAAS)
Time frame: Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
Numerical pain rating scale (SARS) is used to evaluate pain severity. In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
State Anxiety Scale (STAI TX-I)
Time frame: Before and after IUD procedure
items are answered by marking one of the options such as (1) none, (2) a little, (3) a lot, (4) a lot, depending on the severity of the emotion or behavior. There are two types of expressions in the scale. These are reversed or straight forward expressions. reversed expressions; positive emotions express, while direct expressions express negative emotions. When scoring reverse expressions, those with a weight of 1 are converted to 4, and those with a weight of 4 are converted to 1. 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. ints.
Newcastle Nursing Care Satisfaction Scale (NHMS)
Time frame: ria application restriction averages 20 minutes
The scale is a 5-point Likert-type scale consisting of 19 items covering 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.
Virtual Reality Glasses Application Question
Time frame: ria application restriction averages 20 minutes
Virtual Reality Glasses Application Question,It was created by scanning the literature by the researcher.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 17531618Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007 Jun;75(6 Suppl):S55-9. doi: 10.1016/j.contraception.2006.12.004. Epub 2007 Feb 16.
- Background: PubMed 29079143Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.
- Background: PubMed 31112295Gemzell-Danielsson K, Jensen JT, Monteiro I, Peers T, Rodriguez M, Di Spiezio Sardo A, Bahamondes L. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019 Dec;98(12):1500-1513. doi: 10.1111/aogs.13662. Epub 2019 Jun 27.
- Results publication: PubMed 31094575Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019 Jun;24(3):240-245. doi: 10.1080/13625187.2019.1610872. Epub 2019 May 16.
- Results publication: 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.
- Derived from this study: PubMed 41235692Toker E, Gokduman Keles M. The Impact of Virtual Reality with Relaxation Music and Distraction Cards on Pain, Anxiety, and Satisfaction Levels of Women with an Intrauterine Device: A Randomized Controlled Trial. J Midwifery Womens Health. 2026 Jan-Feb;71(1):104-112. doi: 10.1111/jmwh.70048. Epub 2025 Nov 14.
- Home/Newsroom/Fact sheets/Detail/Family planning/contraception methodLink provided by the sponsor.
- WHO. New estimates show worldwide fall in unintended pregnancies since 1990-1994. 2020.Link provided by the sponsor.
- High rates of unintended pregnancies linked to gaps in family planning services: New WHO studyLink provided by the sponsor.
- TNSA. Türkiye Nüfus ve Sağlık Araştırması 2018 Ne Söylüyor? 2018Link provided by the sponsor.
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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.
Eylem Toker contact
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) Group and Group using distraction cards in people with Virtual Reality and Pain, run by Mine Gokduman Keles 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 2 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 12 Apr 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 mine gökduman keleş (05055624560, minegkdmn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Rate and Oxygen Saturation (time frame: ria application restriction averages 20 minutes). The study lists 6 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 NCT05655052, which also lists 6 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 12 Apr 2023.