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The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction

Primary Purpose

Anxiety, Pain, Patient Satisfaction

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Glasses
Sponsored by
Duzce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Papanicolaou Test, Virtual Reality

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: A sufficient level of education to understand study procedures and be able to communicate with site personnel Being in the age range of 30-65, To have Pap Smear test for the first time, Speaking Turkish and reading and writing, No vision and hearing problems, Not using glasses, Not a diagnosed psychiatric disease. Exclusion Criteria: Having any physical or mental problems that may prevent communication To have a Pap Smear test before. Removing virtual reality glasses during the process Not filling the post -test form after the procedure.

Sites / Locations

  • Düzce General Directorate of Public Health Cancer Early Diagnosis Screening and Training CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Group

Control Group

Arm Description

Before starting the process, participants will be informed about the study and their verbal and written consent will be obtained. Participants in the virtual reality group will be shown and introduced to virtual reality glasses before the procedure. After the woman goes to the examination table and takes the appropriate position for the pap smear procedure, virtual reality glasses will be put on the woman by the researcher. The selected video will be played until the Pap smear process is completed. (https://www.youtube.com/watch?v=6ud18oSuCiY&t=30s). When the Pap smear is finished, the glasses will be removed and the woman will be helped to get up from the examination table. In this process, no form will be filled until the participant woman gets dressed and takes the ready position. Thus, the privacy of women will be protected and there will be no violation of ethical rights.

Verbal and written consent will be obtained from the participants before starting the procedure. No intervention will be applied to the participants in the control group. The forms that need to be filled before the procedure will be filled. With the help and guidance of the researcher, the woman will prepare, move to the examination table and take a position. After the Pap smear process is over, the participant woman will get off the examination table with the help of the researcher and get dressed. After the woman is ready after the procedure, she will go to the waiting room and fill out the forms.

Outcomes

Primary Outcome Measures

Anxiety Level
Anxiety will be measured with the Visual Analog Scale (VAS-Anxiety). The Anxiety Visual Analog Scale includes numbers from 0 to 10, the higher the number marked, the higher the level of anxiety felt.Anxiety level will be measured twice, before and after the procedure.
State Anxiety Level
Anxiety level after the procedure will be measured with the State Anxiety Inventory (STAI I). The state anxiety scale measures the level of anxiety felt at the moment. It consists of 20 items, scores range from 20-80. The higher the score, the higher the level of anxiety felt. state anxiety level will be measured once after the pap smear process is completed.

Secondary Outcome Measures

Pain Level
It will be measured with the Visual Analog Scale (VAS). The visual analog scale includes numbers 1-10, as the marked number increases, the level of pain felt increases.
patient satisfaction level
It will be measured by the evaluation form of numerical patient satisfaction. It is formed in a single -item likert type. It is scored between 1-5 points. As the score increases, the level of satisfaction for the Pap Smear test increases.
virtual reality application satisfaction level
Satisfaction with Virtual Reality will be measured with the Evaluation Form. It was created in a 5-point likert type. It consists of 12 items. The highest satisfaction score is 40 points because it also includes negative statements. As the score increases in the range of 40-75 points, satisfaction decreases.

Full Information

First Posted
December 10, 2022
Last Updated
May 30, 2023
Sponsor
Duzce University
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1. Study Identification

Unique Protocol Identification Number
NCT05895188
Brief Title
The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction
Official Title
The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
October 17, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duzce University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research is a randomized controlled experimental study designed to determine the effect of video, which is watched by virtual reality glasses during the procedure, on anxiety, pain and patient satisfaction to women who have had pap smear test.
Detailed Description
Cervical cancer is the most important preventable gynecological cancer that can be diagnosed with early screening among female gynecological cancers. Today, cervical cancer has become an important public health problem (General Directorate of Public According to the data of the Global Cancer Observatory (GLOBOCAN), a subsidiary of the World Health Organization, 604,127 women were diagnosed with cervical cancer in 2020. With these new cases, cervical cancer ranked 4th worldwide in incidence and mortality. In Turkey, the incidence of cervical cancer ranks 3rd among gynecological cancers. In the world and in Turkey. The primary prevention of this cancer type, which has a high mortality rate in addition to its incidence rate, is the Human Papilloma Virus (HPV) vaccine. Secondary prevention includes early diagnosis with screening tests. Screening tests for the diagnosis of cervical cancer are pap smear test and HPV DNA test. Thanks to the Pap smear screening test, the diagnosis can be made even if cervical cancer does not show any symptoms. In addition, preinvasive and invasive lesions of cervical cancer can be detected. Thanks to these features of the Pap smear test, lesions can be detected in the early period, the treatment process can be started early, and mortality and morbidity rates can be reduced. The Pap smear test is an easy-to-apply, inexpensive, reliable and easy-to-access screening test. It has been reported that regular pap smear test screening reduces the mortality and morbidity rate of cervical cancer by 70% in developed countries. It is recommended by the Ministry of Health that women over the age of 30 should have a pap smear test once every 5 years. It is recommended that screening be discontinued in women who have 3 consecutive negative tests or who are over 65 years old. Despite the recommendations and practices of the Ministry of Health, 20% of women in Turkey were screened within the scope of the screening program. Studies conducted in the national and international literature reveal many reasons why women do not have a pap smear test. The primary reason why women do not have a pap smear test is gynecological examination. Women may experience anxiety and worry due to the speculum used during the gynecological examination, the fact that the procedure area is a private area, and the possibility of being diagnosed with cancer as a result of the test. In a study, it was found that 20.7% of women experienced moderate anxiety and 10.9% had high level anxiety before the gynecological examination. In another study, the state anxiety score of women who applied for a pap smear test was found to be high. Women may develop negative attitudes towards screening tests due to the anxiety they experience. For this reason, early diagnosis may miss the opportunity. Özcan et al. recommend that nurses provide supportive care to women during gynecological examination and reduce their anxiety. Distraction method and pain and anxiety management are among the independent roles of nurses. There are many nursing practices that can be done to reduce the anxiety and pain feelings of patients. Virtual reality application is also used as one of these applications. With the developing technology, virtual reality applications have started to be applied as a distraction technique. Created as a result of combining three-dimensional and interactive graphics prepared in virtual reality computer environments with various programs in the computer environment, it has been defined as technologies that draw users directly into a virtual world and create the feeling of being in the real world. The sensors placed in the virtual reality glasses detect the head movements of the user and act in sync with the virtual environment, allowing the individual to see the place where the individual turns his head in the virtual environment. Thanks to this feature of virtual reality glasses, people can make nature, underwater and museum tours. Virtual reality glasses create a feeling of being in a virtual environment. Thus, the person can completely move away from the environment. This feature of virtual reality applications is mostly used in the medical field. People are moving away from the medical environment they are in, they feel as if they are in the images being watched. In this way, their attention can be diverted and their anxiety levels can be reduced. As people focus on the images they see, pain signals reach the brain later and there is a decrease in pain sensation. Anxiety and pain can be reduced with virtual reality application during invasive procedures such as hysteroscopy, amniocentesis, curettage, embryo transfer. reduction studies have been carried out. In the study of Deo et al., qualitative interviews were conducted at the end of the virtual reality application. 85% of the participants stated that the virtual reality application removed them from the examination environment, thus they felt less pain and their anxiety decreased. Studies using virtual reality during gynecological and obstetric diagnosis and treatment procedures have been found in the literature. In the available literature, no study has been found in which virtual reality is applied to women who will undergo pap smear test. With this study, it was aimed to increase patient satisfaction by reducing the pain and anxiety experienced during the pap smear screening test. In addition to this purpose, this study is important in terms of showing that virtual reality application, which is a product of developing technology, is adaptable and applicable to nursing care. It is thought that the health worker can also apply the procedure more easily, thanks to the reduction and relaxation of the anxiety of the woman during the procedure. As a result of the study, it is thought that if the pain and anxiety levels of women are reduced, the rates of having pap smear screening test will increase in the long run. In the study of Marashi et al., negative experiences during the first test were shown as one of the reasons why women did not have a pap smear test. It is thought that the negative experiences of women will be minimized by reducing the level of pain and anxiety. It is thought that the results of the research will contribute to the current literature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Patient Satisfaction
Keywords
Papanicolaou Test, Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In the study, there are two groups, the virtual reality group in which virtual reality glasses were applied and the control group, which did not apply any intervention.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
There are two groups in the study and the informed consent texts of these groups are different. In this way, the participants will not know which group they belong to. The randomization table of the study was made by an independent researcher, so the researcher would not know which patient was in which group. At the end of the research, data analysis will be done by an independent statistician, and the statistician will not know which patient's data belongs to which group.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
Before starting the process, participants will be informed about the study and their verbal and written consent will be obtained. Participants in the virtual reality group will be shown and introduced to virtual reality glasses before the procedure. After the woman goes to the examination table and takes the appropriate position for the pap smear procedure, virtual reality glasses will be put on the woman by the researcher. The selected video will be played until the Pap smear process is completed. (https://www.youtube.com/watch?v=6ud18oSuCiY&t=30s). When the Pap smear is finished, the glasses will be removed and the woman will be helped to get up from the examination table. In this process, no form will be filled until the participant woman gets dressed and takes the ready position. Thus, the privacy of women will be protected and there will be no violation of ethical rights.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Verbal and written consent will be obtained from the participants before starting the procedure. No intervention will be applied to the participants in the control group. The forms that need to be filled before the procedure will be filled. With the help and guidance of the researcher, the woman will prepare, move to the examination table and take a position. After the Pap smear process is over, the participant woman will get off the examination table with the help of the researcher and get dressed. After the woman is ready after the procedure, she will go to the waiting room and fill out the forms.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Glasses
Intervention Description
From the beginning to the end of the procedure, women will watch the selected nature video.
Primary Outcome Measure Information:
Title
Anxiety Level
Description
Anxiety will be measured with the Visual Analog Scale (VAS-Anxiety). The Anxiety Visual Analog Scale includes numbers from 0 to 10, the higher the number marked, the higher the level of anxiety felt.Anxiety level will be measured twice, before and after the procedure.
Time Frame
15 minutes
Title
State Anxiety Level
Description
Anxiety level after the procedure will be measured with the State Anxiety Inventory (STAI I). The state anxiety scale measures the level of anxiety felt at the moment. It consists of 20 items, scores range from 20-80. The higher the score, the higher the level of anxiety felt. state anxiety level will be measured once after the pap smear process is completed.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Pain Level
Description
It will be measured with the Visual Analog Scale (VAS). The visual analog scale includes numbers 1-10, as the marked number increases, the level of pain felt increases.
Time Frame
15 minutes
Title
patient satisfaction level
Description
It will be measured by the evaluation form of numerical patient satisfaction. It is formed in a single -item likert type. It is scored between 1-5 points. As the score increases, the level of satisfaction for the Pap Smear test increases.
Time Frame
15 minutes
Title
virtual reality application satisfaction level
Description
Satisfaction with Virtual Reality will be measured with the Evaluation Form. It was created in a 5-point likert type. It consists of 12 items. The highest satisfaction score is 40 points because it also includes negative statements. As the score increases in the range of 40-75 points, satisfaction decreases.
Time Frame
15 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Being a woman to have a pap smear test
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A sufficient level of education to understand study procedures and be able to communicate with site personnel Being in the age range of 30-65, To have Pap Smear test for the first time, Speaking Turkish and reading and writing, No vision and hearing problems, Not using glasses, Not a diagnosed psychiatric disease. Exclusion Criteria: Having any physical or mental problems that may prevent communication To have a Pap Smear test before. Removing virtual reality glasses during the process Not filling the post -test form after the procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hacer GÜLEN SAVAŞ, PhD
Phone
0850 800 81 81
Ext
3506
Email
hacergulen@duzce.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Ruken Seven, MSc
Phone
5459589076
Ext
+90
Email
sevenruken@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hacer GÜLEN SAVAŞ, PhD
Organizational Affiliation
Duzce University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Düzce General Directorate of Public Health Cancer Early Diagnosis Screening and Training Center
City
Düzce
State/Province
Merkez
ZIP/Postal Code
81010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ökkeş Kepek, Dr.
Phone
(0380) 514 80 00
Email
duzce@saglik.gov.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect Of Virtual Reality Glasses Applied During Pap Smear On Anxiety, Pain And Patient Satisfaction

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