The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography

February 15, 2024 updated by: Ardahan University

The Effect of Virtual Reality Applied to Women Before Mammography on Pain, Anxiety and Satisfaction Level: Single-Blind Randomized Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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.
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.
Active Comparator: Control group
No additional application to routine procedures will be applied to the control group.
Other: routine maintenance
routine maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Comparison Scale
Time Frame: an average of 6 months after the completion of the initiative
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
State Anxiety Inventory
Time Frame: an average of 6 months after the completion of the initiative
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
Satisfaction Evaluation Scale
Time Frame: an average of 6 months after the completion of the initiative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardahan University

Collaborators

Kafkas University

Investigators

  • Principal Investigator: Derya ŞİMŞEKLİ, Lecturer, Ardahan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ArdahanU-Simsekli-DS-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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