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Completed

NCT Number: NCT05662683

The Effect of Virtual Reality and Distraction Cards on Pain

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.

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Key information

Conditions

Smear Layer Anxiety Disorders Cervical Cancer Dental Deposits Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TurkishMoHKahramanmarasPH

Kahramanmaraş, 46050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Group

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.

Virtual Reality (VR) Breathing Exercise Group

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

Other Gov

Registry information

Official study title

The Effect of Virtual Reality and Distraction Cards on Pain, Anxiety and Satisfaction Levels of Women Who Have Pap-Smears

Acronym: Pap-Smear

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 22, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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