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CompletedNCT06265207Updated Mar 3, 2025

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

An interventional study of Virtual reality and routine maintenance in Mammography and Early Diagnosis of Cancer, sponsored by Ardahan University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Ardahan University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Mammography
  • Early Diagnosis of Cancer

Keywords

  • Mammography
  • virtual reality
  • pain
  • anxiety
  • satisfaction
03

In context

Lead sponsor

Ardahan University is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Being screened for breast cancer
  • having vision or hearing problems
  • being under 18 years of age.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • 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

  • Active comparator
    Control group

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

    Other: routine maintenance

Interventions

  • OtherVirtual 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.

  • Otherroutine maintenance

    routine maintenance

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: an average of 6 months after the completion of the initiative

  2. 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.

    Time frame: an average of 6 months after the completion of the initiative

  3. 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.

    Time frame: an average of 6 months after the completion of the initiative

07

Study locations

1 site
  • Cancer Early Diagnosis, Screening and Education Center Unit
    Kars, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06265207
Lead sponsor
Ardahan University
Collaborators
Kafkas University
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Feb 15, 2024
Primary completion
Sep 15, 2024
Completion
Sep 27, 2024
Last update
Mar 3, 2025

Study contacts

Derya ŞİMŞEKLİ, Lecturer
principal investigator · Ardahan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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