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

NCT06265207 | Completed

• 1 other identifier: ArdahanU-Simsekli-DS-02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mammography; Early Diagnosis of Cancer

Keywords

Mammography; virtual reality; pain; anxiety; satisfaction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

No additional application to routine procedures will be applied to the control group.

Other: routine maintenance

Interventions

Virtual reality OTHER

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.

Experimental group

routine maintenance OTHER

routine maintenance

Control group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: Only female applicants will be included due to breast cancer screening.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being screened for breast cancer
• having vision or hearing problems
• being under 18 years of age.

Sponsors & Collaborators

• Ardahan University: lead
• Kafkas University: collaborator

Study Sites (1)

Cancer Early Diagnosis, Screening and Education Center Unit

Kars, Kars, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Derya ŞİMŞEKLİ, Lecturer

  Ardahan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Since the researcher will be conducting the research, blinding will not be possible, and separate consent forms were prepared for the experimental and control groups, without specifying which group they were in, and it was planned to blind the participants in this way. In addition, in order to prevent statistical bias, it is planned to prevent bias in data analysis by coding the data as first group and second group, rather than experimental and control group, when entering the data into SPSS, and by not giving information about which group is the experiment and which is the control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Blind Parallel Group Randomized Controlled Trial

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 27, 2024
• Last Updated: March 3, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)