Clinical trial NCT05662683: The Effect of Virtual Reality and Distraction Cards on Pain
Official title: The Effect of Virtual Reality and Distraction Cards on Pain, Anxiety and Satisfaction Levels of Women Who Have Pap-Smears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smear Layer
Cervical Cancer
Keywords: Virtual Reality
Distraction Cards
Pain
Anxiety
pap-smear
Lead sponsor: Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
Sponsor class: OTHER_GOV
First posted: 2022-12-22
Enrollment: 132
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.
measure: Verbal Category Scale
timeFrame: before inspection pap smear
measure: Verbal Category Scale
timeFrame: (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.
measure: State Anxiety Scale
timeFrame: before PAP-SMEAR procedure
measure: State Anxiety Scale
timeFrame: after PAP-SMEAR procedure
measure: Newcastle Nursing Care Satisfaction Scale
timeFrame: After PAP-SMEAR ALDIRAN procedure
measure: Pulse Rate and Oxygen Saturation
timeFrame: 20 minutes during pap smear
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: TurkishMoHKahramanmarasPH
Study officials:
affiliation: Ministry of Health
name: mine gökduman keleş, Midwifery
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.