Breast CancerNCT07745946
The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety
A study testing Breathing exercise and Virtual Reality Glasses in people with Breast Cancer, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of virtual reality glasses use and breathing exercise application on anxiety levels in breast cancer patients undergoing chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breathing exercise and Virtual Reality Glasses
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Apr 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with breast cancer
- Aged 18 years or older
- Receiving treatment in the outpatient (day-case) chemotherapy unit
- Voluntarily agreeing to participate in the study
Who cannot join
- Having a respiratory-related disease
- Having visual or hearing impairment
- Having a communication problem
- Having a diagnosis of psychiatric disease
- Having a cancer diagnosis other than breast cancer
- Receiving ice-cap therapy to prevent/reduce hair loss or cryotherapy for hand-foot neuropathy during chemotherapy treatment
- Having vertigo or head-neck disorders
- Patients hospitalized for their first cycle of chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety During Chemotherapy Treatment in Breast Cancer Patients: A Randomized Controlled Trial
This study was conducted to determine the effect of virtual reality glasses use and breathing exercise application on anxiety levels in breast cancer patients undergoing chemotherapy treatment.
Read the detailed description
Cancer remains one of the leading causes of morbidity worldwide, with anxiety recognized as one of the most frequently reported psychological symptoms among patients undergoing chemotherapy. In breast cancer patients specifically, anxiety has been shown to negatively affect quality of life, reduce treatment adherence, and intensify the perceived burden of other physical symptoms during chemotherapy sessions.
While pharmacological approaches remain part of standard symptom management, non-pharmacological interventions-such as distraction techniques, relaxation exercises, guided imagery, and music therapy-are increasingly used by nurses due to their low cost, safety, ease of implementation, and ability to actively engage patients in their own care. Among these, virtual reality (VR) technology has emerged as a promising distraction-based intervention, with prior studies reporting reductions in stress, anxiety, and treatment-related discomfort. Similarly, breathing exercises have demonstrated anxiolytic effects through their regulatory influence on the autonomic nervous system, with recent systematic reviews and meta-analyses confirming significant reductions in anxiety and depression among cancer patients.
Despite the individual evidence supporting each intervention, few studies have directly compared the effectiveness of virtual reality glasses and breathing exercises within the same patient population, and randomized controlled trials evaluating both interventions concurrently in breast cancer patients undergoing chemotherapy remain limited.
This study is designed as a randomized controlled trial to determine and compare the effects of virtual reality glasses and breathing exercise applications on anxiety levels in breast cancer patients receiving chemotherapy. Eligible participants will be randomly assigned to one of the study groups (virtual reality glasses, breathing exercise, or standard care/control), and anxiety will be assessed using a validated anxiety measurement instrument (State-Trait Anxiety Inventory, VAS) before and after the intervention during chemotherapy sessions.The findings of this study are expected to contribute to the evidence base for non-pharmacological anxiety management in oncology nursing practice and to help identify effective, low-cost interventions that can be integrated into routine chemotherapy care.
- Conditions
- Breast Cancer
- Being tested
- Breathing exercise, Virtual Reality Glasses
- Keywords
- Nursing, cancer, anxiety, chemotherapy, breathing exercise, virtual reality, breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseBehavioural
Also called Using Virtual Reality Glasses
Intervention 1: Breathing Exercise In this study, participants in the breathing exercise group will perform diaphragmatic (deep) breathing exercises during their chemotherapy sessions. Diaphragmatic breathing promotes deeper, more controlled respiration through effective use of the diaphragm muscle, producing a balancing effect on the autonomic nervous system, while slow rhythmic breathing supports relaxation by increasing heart rate variability. Participants will be guided by a nurse/researcher to perform the exercise for [10 minutes]
Virtual Reality GlassesBehavioural
Intervention 2: Virtual Reality Glasses Participants in the virtual reality group will wear VR glasses displaying calming, distraction-based visual and auditory content during their chemotherapy infusion. This intervention aims to redirect attention away from the treatment process, thereby reducing perceived stress and anxiety. The VR session will be applied for [10 minutes]
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise Group | Experimental | Breathing exercise applied during chemotherapy sessions Receives: Behavioral: Breathing exercise |
| Virtual Reality Glasses Group | Experimental | Use of virtual reality glasses during chemotherapy sessions Receives: Behavioral: Virtual Reality Glasses |
| Control (Standard Care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Level
Anxiety levels will be measured using a validated anxiety assessment tool ( State-Trait Anxiety Inventory [STAI], VAS, Vital Signs form before and after the intervention (virtual reality glasses, breathing exercise, or standard care) in each study group. The change in anxiety scores between baseline and post-intervention will be compared across the three groups.
Measured: Baseline (before intervention) and immediately after intervention during the chemotherapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Mar 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Elmalı Şimşek, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745946
- Sponsor's protocol ID
- 2025-03/18
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety During Chemotherapy Treatment in Breast Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07745946
- Acronym / sponsor ID
- 2025-03/18
- Conditions
- Breast Cancer
- Keywords
- Nursing, cancer, anxiety, chemotherapy, breathing exercise, virtual reality, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 4 Aug 2026 (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.
This study was conducted to determine the effect of virtual reality glasses use and breathing exercise application on anxiety levels in breast cancer patients undergoing chemotherapy treatment.
Detailed description
Cancer remains one of the leading causes of morbidity worldwide, with anxiety recognized as one of the most frequently reported psychological symptoms among patients undergoing chemotherapy. In breast cancer patients specifically, anxiety has been shown to negatively affect quality of life, reduce treatment adherence, and intensify the perceived burden of other physical symptoms during chemotherapy sessions.
While pharmacological approaches remain part of standard symptom management, non-pharmacological interventions-such as distraction techniques, relaxation exercises, guided imagery, and music therapy-are increasingly used by nurses due to their low cost, safety, ease of implementation, and ability to actively engage patients in their own care. Among these, virtual reality (VR) technology has emerged as a promising distraction-based intervention, with prior studies reporting reductions in stress, anxiety, and treatment-related discomfort. Similarly, breathing exercises have demonstrated anxiolytic effects through their regulatory influence on the autonomic nervous system, with recent systematic reviews and meta-analyses confirming significant reductions in anxiety and depression among cancer patients.
Despite the individual evidence supporting each intervention, few studies have directly compared the effectiveness of virtual reality glasses and breathing exercises within the same patient population, and randomized controlled trials evaluating both interventions concurrently in breast cancer patients undergoing chemotherapy remain limited.
This study is designed as a randomized controlled trial to determine and compare the effects of virtual reality glasses and breathing exercise applications on anxiety levels in breast cancer patients receiving chemotherapy. Eligible participants will be randomly assigned to one of the study groups (virtual reality glasses, breathing exercise, or standard care/control), and anxiety will be assessed using a validated anxiety measurement instrument (State-Trait Anxiety Inventory, VAS) before and after the intervention during chemotherapy sessions.The findings of this study are expected to contribute to the evidence base for non-pharmacological anxiety management in oncology nursing practice and to help identify effective, low-cost interventions that can be integrated into routine chemotherapy care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Experimental | Behavioral: Breathing exerciseBreathing exercise applied during chemotherapy sessions |
| Virtual Reality Glasses Group | Experimental | Behavioral: Virtual Reality GlassesUse of virtual reality glasses during chemotherapy sessions |
| Control (Standard Care) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with breast cancer
- Aged 18 years or older
- Receiving treatment in the outpatient (day-case) chemotherapy unit
- Voluntarily agreeing to participate in the study
Key exclusion criteria (8 listed)
- Having a respiratory-related disease
- Having visual or hearing impairment
- Having a communication problem
- Having a diagnosis of psychiatric disease
- Having a cancer diagnosis other than breast cancer
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 |
|---|---|---|
| Breathing exerciseAlso: Using Virtual Reality GlassesIntervention 1: Breathing Exercise In this study, participants in the breathing exercise group will perform diaphragmatic (deep) breathing exercises during their chemotherapy sessions. Diaphragmatic breathing promotes deeper, more controlled respiration through effective use of the diaphragm muscle, producing a balancing effect on the autonomic nervous system, while slow rhythmic breathing supports relaxation by increasing heart rate variability. Participants will be guided by a nurse/researcher to perform the exercise for [10 minutes] | Behavioural | Breathing Exercise Group |
| Virtual Reality GlassesIntervention 2: Virtual Reality Glasses Participants in the virtual reality group will wear VR glasses displaying calming, distraction-based visual and auditory content during their chemotherapy infusion. This intervention aims to redirect attention away from the treatment process, thereby reducing perceived stress and anxiety. The VR session will be applied for [10 minutes] | Behavioural | Virtual Reality Glasses Group |
Primary outcome
Change in Anxiety Level
Time frame: Baseline (before intervention) and immediately after intervention during the chemotherapy session
Anxiety levels will be measured using a validated anxiety assessment tool ( State-Trait Anxiety Inventory [STAI], VAS, Vital Signs form before and after the intervention (virtual reality glasses, breathing exercise, or standard care) in each study group. The change in anxiety scores between baseline and post-intervention will be compared across the three groups.
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 6 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise and Virtual Reality Glasses in people with Breast Cancer, run by Ankara Medipol 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 4 inclusion and 8 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 6 Aug 2026. 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?
Change in Anxiety Level (time frame: Baseline (before intervention) and immediately after intervention during the chemotherapy session). 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 6 Aug 2026.