MammographyNCT06265207
The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography
A study testing Virtual reality and routine maintenance in people with Mammography and Early Diagnosis of Cancer, run by Ardahan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammography, Early Diagnosis of Cancer
- What is being tested?
- Virtual reality and routine maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 27 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being screened for breast cancer
- having vision or hearing problems
- being under 18 years of age.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cancer Early Diagnosis, Screening and Education Center Unit
Kars, Kars
About this study
Official title: 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.
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.
- Conditions
- Mammography, Early Diagnosis of Cancer
- Being tested
- Virtual reality, routine maintenance
- Keywords
- Mammography, virtual reality, pain, anxiety, satisfaction
- Medical subject headings
- Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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 maintenanceOther
routine maintenance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual reality |
| Control group | Active comparator | No additional application to routine procedures will be applied to the control group. Receives: Other: routine maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: an average of 6 months after the completion of the initiative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blind Parallel Group Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardahan University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafkas University
- Responsible party
- Sponsor
- Investigators
- Derya ŞİMŞEKLİ, Lecturer, Principal investigator, Ardahan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265207
- Sponsor's protocol ID
- ArdahanU-Simsekli-DS-02
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Applied to Women Before Mammography on Pain, Anxiety and Satisfaction Level: Single-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06265207
- Acronym / sponsor ID
- ArdahanU-Simsekli-DS-02
- Conditions
- Mammography, Early Diagnosis of Cancer
- Keywords
- Mammography, virtual reality, pain, anxiety, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ardahan UniversityUniversity, hospital or other
- Collaborators
- Kafkas University
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single Blind Parallel Group Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Virtual realityBefore 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. |
| Control group | Active comparator | Other: routine maintenanceNo additional application to routine procedures will be applied to the control group. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Being screened for breast cancer
- having vision or hearing problems
- being under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityBefore 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 | Experimental group |
| routine maintenanceroutine maintenance | Other | Control group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya ŞİMŞEKLİ, Lecturer principal investigator
Ardahan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and routine maintenance in people with Mammography and Early Diagnosis of Cancer, run by Ardahan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Comparison Scale (time frame: an average of 6 months after the completion of the initiative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.