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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06265207
Other study ID # ArdahanU-Simsekli-DS-02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 15, 2024
Est. completion date April 15, 2025

Study information

Verified date February 2024
Source Ardahan University
Contact Derya SIMSEKLI, Lecturer (MSc)
Phone 05545965789
Email deryasimsekli95@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it is planned to determine the effect of virtual reality applied to women before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals applying for breast cancer screening will first be randomly divided into experimental and control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the experimental group before the mammography procedure. A relaxing video will be watched with virtual reality glasses and the mammography will be performed. At the end of the mammography, the relevant forms will be applied to the individuals again. The control group will not be subjected to any additional application that will continue with the applied routine.


Description:

Purpose and duration of the research: This research is to determine the effect of virtual reality applied to women before mammography on the pain, anxiety and satisfaction levels. Materials and methods of the research: This research is planned to be carried out in a pre-test post-test single-blind randomized controlled experimental design. Research Questions/Hypotheses: Hypotheses of the Research H0: Virtual reality applied to women before mammography has no effect on pain, anxiety and satisfaction levels. H1a: Virtual reality applied to women before mammography has an effect on pain. H1b: Virtual reality applied to women before mammography has an effect on anxiety. H1c: Virtual reality applied to women before mammography has an effect on the satisfaction level. Dependent variables of the research; these are the scores to be taken from the Visual Comparison Scale, State Anxiety Inventory and Satisfaction Rating Scale. The independent variable of the research is; This is a video that will be watched with virtual reality glasses. The research was planned to be carried out in the Cancer Early Diagnosis, Screening and Education Center (Ketem) unit. Individuals who applied to Kars Provincial Health Directorate KETEM Unit during the research process will constitute the population of the research. A power analysis was performed to determine the sample size of the study, and accordingly, with a Cohen-d effect size of 0.80 (Goulet-Pelletier & Cousineau, 2018; Kilic, 2014), a power of 0.95, an alpha margin of error of 0.05, the minimum sample size planned to be included in the study was 35 for the experimental group, It was determined that there should be a total of 70 participants, 35 in the control group. Considering the 10% loss, it is planned to include four more patients in each group, making a total of 78 participants the sample of the study. Randomization and blinding The block randomization method was chosen in the study to eliminate selection bias and distribute participants equally to the groups. After determining the participants who meet the inclusion and exclusion criteria, a pre-test was applied to those who voluntarily agreed to participate, and then they will be randomized into experimental and control groups. 78 participants who met the research criteria were assigned to groups by block randomization. It will be decided which group is the experiment and which group is the control, by a lottery drawn by a nurse independent of the study before the implementation. Descriptive Information Form, Visual Comparison Scale, State Anxiety Inventory and Satisfaction Evaluation Scale will be used as data collection tools.Visual Comparison Scale; It provides a simple assessment of pain. Pain is rated between mild pain = 0 and unbearable pain = 10. Pain intensity is categorized as 1-3 mild, 4-6 moderate, and 7-10 severe. State Anxiety Inventory; It was developed by Spielberger et al. to evaluate the anxiety level of individuals. The scale measures trait and state anxiety. In this study, 20 items that evaluate state anxiety will be used to evaluate state anxiety. The scale is scored in a four-point Likert type, as "1 = not at all, 2 = a little, 3 = a lot and 4 = completely". The score obtained shows the state anxiety score. The lowest score that can be obtained from the scale is 20, while the highest score is 80. A high score indicates high anxiety, while a low score indicates low anxiety level. Satisfaction Evaluation Scale; It is a scale that individuals can easily understand and is easy to apply. It is a scale indicated by a horizontal or vertical line, ranging from 0 = not at all satisfied to 10 = quite satisfied. The evaluation is made based on the average value.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 78
Est. completion date April 15, 2025
Est. primary completion date March 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria: - Having applied for mammography for screening purposes, - having no communication problems, - being over 18 years of age, - not having a history of breast cancer - voluntarily agreeing to participate in the study Exclusion Criteria: - Being screened for breast cancer - having vision or hearing problems - being under 18 years of age.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual reality
Before the mammography, a 20-minute relaxing video featuring nature and forest views will be watched with VR SHINECON 360 degree glasses. Since it is seen in the literature that watching a video for 20 minutes provides effective results, the video viewing time was determined as 20 minutes.
routine maintenance
routine maintenance

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ardahan University Kafkas University

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Comparison Scale It provides a simple assessment of pain. Pain is rated between mild pain = 0 and unbearable pain = 10. Pain intensity is categorized as 1-3 mild, 4-6 moderate and 7-10 severe. an average of 6 months after the completion of the initiative
Primary State Anxiety Inventory The scale measures trait and state anxiety. In this study, 20 items that evaluate state anxiety will be used to evaluate state anxiety. The scale is scored in a four-point Likert type, as "1 = not at all, 2 = a little, 3 = a lot and 4 = completely". The lowest score that can be obtained from the scale is 20, while the highest score is 80. A high score indicates high anxiety, while a low score indicates low anxiety level. an average of 6 months after the completion of the initiative
Primary Satisfaction Evaluation Scale It is a scale that individuals can easily understand and is easy to apply. It is a scale indicated by a horizontal or vertical line, ranging from 0 = not at all satisfied to 10 = quite satisfied. The evaluation is made based on the average value. an average of 6 months after the completion of the initiative
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