The Effect of Virtual Reality Glasses Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'

Pain Clinical Trial

— Virtual  

Official title:

The Effect of Virtual Reality Glasses and Distraction Cards on Women's Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655052
• Other study ID #: TurkishMoHKahramanmaras
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
• Contact: mine gökduman keles
• Phone: 05055624560
• Email: minegkdmn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• between the ages of 18-45,
• IUD applied,

Exclusion Criteria:

• Having visual and auditory disabilities,
• Use of misoprostol during the procedure,
• Pre-procedure pain medication use,
• Pre-procedure anxiety medication use.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Virtual Reality

Intervention

Device:
• Virtual Reality (VR) Group
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 cards
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.

Locations

Country	Name	City	State
Turkey	TurkishMoHKahramanmarasPH	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Mine Gokduman Keles

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Akdemir 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. — View Citation

Dina 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. — View Citation

Gemzell-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. — View Citation

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. — View Citation

Hylton 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	ria application restriction averages 20 minutes
Primary	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.	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).
Primary	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).	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).
Primary	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.	Before and after IUD procedure
Primary	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.	ria application restriction averages 20 minutes
Primary	Virtual Reality Glasses Application Question	Virtual Reality Glasses Application Question,It was created by scanning the literature by the researcher.	ria application restriction averages 20 minutes

External Links

•   High rates of unintended pregnancies linked to gaps in family planning services: New WHO study
•   Home/Newsroom/Fact sheets/Detail/Family planning/contraception method
•   TNSA. Türkiye Nüfus ve Saglik Arastirmasi 2018 Ne Söylüyor? 2018
•   WHO. New estimates show worldwide fall in unintended pregnancies since 1990-1994. 2020.