The Effect of Virtual Reality and Distraction Cards on Pain

NCT05662683 | Completed

• 1 other identifier: TurkishHKahramanmarasPH
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Smear Layer; Cervical Cancer

Keywords

Virtual Reality; Distraction Cards; Pain; Anxiety; pap-smear

Outcome Measures

Primary Outcomes (7)

• Numerical Pain Rating Scale

  In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

  (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.

• Verbal Category Scale

  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.

  before inspection pap smear

• Verbal Category Scale

  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.

  (1) before inspection (2) speculum insertion (3) also performing the PAP-SMEAR import process; (4) will be evaluated after the end of the transaction.

• State Anxiety Scale

  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.

  before PAP-SMEAR procedure

• State Anxiety Scale

  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.

  after PAP-SMEAR procedure

• Newcastle Nursing Care Satisfaction Scale

  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.

  After PAP-SMEAR ALDIRAN procedure

• 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

  20 minutes during pap smear

Study Arms (4)

Working Group 1

EXPERIMENTAL

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.

Other: Virtual Reality (VR)

Working Group 2

EXPERIMENTAL

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

Other: Distraction Cards Practice Group

Working Group 3

EXPERIMENTAL

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.

Other: Virtual Reality (VR) Breathing Exercise Group

Control Group

NO INTERVENTION

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

Interventions

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.

Working Group 1

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.

Working Group 2

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.

Working Group 3

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate: lead

Study Sites (1)

TurkishMoHKahramanmarasPH

Kahramanmaraş, 46050, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 28067068 BACKGROUND

• 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.

  PMID: 23962572 BACKGROUND

• 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.

  PMID: 27621913 BACKGROUND

• 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.

  PMID: 31793099 BACKGROUND

• 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.

  PMID: 29025113 BACKGROUND

• 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.

  PMID: 33478718 BACKGROUND

• 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.

  PMID: 33786484 BACKGROUND

Related Links

• WHO. Cervical Cancer Country Profiles. 2021.

MeSH Terms

Conditions

Smear Layer; Uterine Cervical Neoplasms; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• mine gökduman keleş, Midwifery

  Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: IT WILL BE APPLIED BY THE SAME HEALTH PERSONNEL WORKING AT THE KETEM CENTER After the women who meet the sample criteria of the study are determined and they accept to participate in the study, it will be determined which group the women are in from the list determined by randomization (determined from the www.randomizer.org site) according to the acceptance sequence number of the women.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwifery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 22, 2022
• Study Start: November 20, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

TU (1)