The Effect of Virtual Reality and Distraction Cards on Pain

NCT ID: NCT05662683

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2023-01-30

Brief 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 . 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.

Conditions

Smear Layer; Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Working Group 1

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.

Group Type: EXPERIMENTAL

Virtual Reality (VR)

Intervention Type: 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.

Working Group 2

Distraction cards containing five optical illusion figures will be shown to the women by the researcher

Group Type: EXPERIMENTAL

Distraction Cards Practice Group

Intervention Type: OTHER

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.

Working Group 3

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.

Group Type: EXPERIMENTAL

Virtual Reality (VR) Breathing Exercise Group

Intervention Type: OTHER

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.

Control Group

The maintenance and applications in the routine PAP-SMEAR application will be done exactly.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Distraction Cards Practice Group

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.

Intervention Type: OTHER

Virtual Reality (VR) Breathing Exercise Group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Those with visual and auditory disabilities, Using misoprostol during the procedure, Using pain medication before the procedure

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mine Gokduman Keles

Midwifery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mine gökduman keleş, Midwifery

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Locations

TurkishMoHKahramanmarasPH

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28067068 (View on PubMed)

Angioli 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.

Reference Type: BACKGROUND

PMID: 23962572 (View on PubMed)

Ulker 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.

Reference Type: BACKGROUND

PMID: 27621913 (View on PubMed)

Basak 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.

Reference Type: BACKGROUND

PMID: 31793099 (View on PubMed)

Gupta 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.

Reference Type: BACKGROUND

PMID: 29025113 (View on PubMed)

Gur 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.

Reference Type: BACKGROUND

PMID: 33478718 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33786484 (View on PubMed)

Study Documents

Document Type: REVIEW

Ozturk, Y. (2020). Barriers to Women Having Pap Smear Screening Test .29 (1), 61-68. DOI: 10.17942/sted.466811

View Document

Related Links

https://www.who.int/teams/noncommunicable-diseases/surveillance/data/cervical-cancer-profiles

WHO. Cervical Cancer Country Profiles. 2021.

Other Identifiers

TurkishHKahramanmarasPH

Identifier Type: -

Identifier Source: org_study_id