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NCT Number: NCT07731477

The Effect of a Virtual Reality-Based Mindfulness Intervention on Anxiety, Comfort, Sleep, and Fatigue in Breast Cancer Patients Undergoing Chemotherapy

Breast cancer is a public health issue with a high incidence among women worldwide, and its prevalence continues to increase each year. A breast cancer diagnosis brings significant physical, emotional, social, economic, and occupational changes. Chemotherapy, one of the most commonly used treatment modalities in cancer therapy, causes various physical and emotional symptoms while treating the disease. However, it is well known that these symptoms induced by chemotherapy can be prevented or alleviated through effective treatment and nursing interventions.

Recently, virtual reality (VR) and mindfulness-based interventions have been reported as effective tools and methods for managing the physical and psychological symptoms experienced by cancer patients.

The present study aims to evaluate the effect of a VR-integrated mindfulness-based intervention on anxiety, comfort, sleep, and fatigue levels among women newly diagnosed with breast cancer, both before and during chemotherapy treatment. The study is designed as a randomized controlled trial (RCT).

The study population will consist of individuals diagnosed with breast cancer at the Oncology Outpatient Clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between May 2025 and December 2026. The study sample will include female breast cancer patients who are scheduled to receive adjuvant chemotherapy, meet the inclusion criteria, and volunteer to participate in the study.

According to the power analysis (with a 30% additional error margin), a total of 50 participants will be included - 25 in the intervention group and 25 in the control group.

The data will be collected using the following instruments: Patient Information Form, Beck Depression Inventory, Cancer Fatigue Scale, General Comfort Questionnaire-Short Form, State Anxiety Inventory, Jenkins Sleep Scale, and the Mindfulness-Based Self-Efficacy Scale.

It is expected that, as a result of this study, compared to the control group, participants in the intervention group who receive the VR-Mindfulness intervention during breast cancer treatment will demonstrate reduced levels of fatigue and anxiety and improved comfort and sleep quality.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital, Ministry of Health, Republic of Turkey

Ankara, 06830, Turkey (Türkiye)

Location status: Recruiting

Location contact

GİZEM CANSIZ UÇAR, Registered Nurse

CONTACT

[email protected]

+905342396480

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnosed with breast cancer, Female and aged 18 years or older, Diagnosed with stage II or III breast cancer, Scheduled to receive chemotherapy for breast cancer for the first time in the adjuvant or neoadjuvant setting, using either the CA regimen [C: cyclophosphamide; A: doxorubicin (Adriamycin)] or the TC regimen [T: docetaxel; C: cyclophosphamide], with or without paclitaxel, trastuzumab, docetaxel, or carboplatin, Scheduled to receive chemotherapy but have not yet started treatment, Have a Beck Depression Inventory (BDI) score of ≤30, have no physician-diagnosed psychiatric disorder according to the DSM-5 diagnostic criteria, and are not receiving treatment for a psychiatric disorder (Appendix 8), Have completed at least primary school education, Voluntarily agree to participate in the study.

Exclusion criteria

Presence of metastasis, History of seizures, Presence of vertigo, Presence of motion sickness with a tendency toward nausea and vomiting, Communication difficulties, including hearing, visual, or speech impairments, Unwillingness to participate in the study. Withdrawal Criteria

Participants will be withdrawn from the study if:

They discontinue the treatment protocol at any stage, Their treatment protocol is changed, They no longer wish to continue participating in the study.

Treatment and study plan

VR-Based Mindfulness Intervention

Behavioral

The mindfulness intervention content was developed collaboratively by the research team and a mindfulness expert, based on a literature-informed design tailored to the study's aims and target population. Among the researchers, GCU has completed training in Mindfulness-Based Stress Reduction (MBSR), simulation-based practice, and has prior experience working with breast cancer patients. The mindfulness expert (EU), a licensed medical doctor, holds certifications in Mindfulness Teaching (Bangor University, UK), Professional Coaching (CTI), and the Mindfulness in Schools Project (UK). To align with the study objectives, mindfulness contents addressing anxiety, comfort, sleep, and fatigue were created by the team and the expert.

Primary outcomes

  1. Fatigue Assessed Using the Cancer Fatigue Scale

    Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

    Fatigue will be assessed using the Cancer Fatigue Scale. The 15-item scale produces a total score ranging from 0 to 60. Higher scores indicate greater fatigue severity.

  2. Comfort Assessed Using the General Comfort Questionnaire-Short Form

    Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

    Comfort will be assessed using the General Comfort Questionnaire-Short Form. The 28-item scale produces a total score ranging from 28 to 168. Higher scores indicate a higher level of comfort.

  3. Sleep Quality Assessed Using the Jenkins Sleep Scale

    Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

    Sleep quality will be assessed using the Jenkins Sleep Scale. The four-item scale produces a total score ranging from 0 to 20. Higher scores indicate more frequent sleep problems and poorer sleep quality.

  4. Anxiety Assessed Using the State-Trait Anxiety Inventory-State Anxiety Subscale

    Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

    Anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory. The 20-item subscale produces a total score ranging from 20 to 80. Higher scores indicate greater state anxiety.

  5. Mindfulness-Based Self-Efficacy Assessed Using the Mindfulness-Based Self-Efficacy Scale-Revised

    Time frame: Assessed three times: after chemotherapy education and before Cycle 1; after the third virtual reality mindfulness session during Cycle 2; and after the sixth session, 2-3 weeks after Cycle 4. Cycles occur every 14 or 21 days.

    Mindfulness-based self-efficacy will be assessed using the 22-item Mindfulness-Based Self-Efficacy Scale-Revised. The mean score ranges from 0 to 4. Higher scores indicate greater mindfulness-based self-efficacy.

Study contacts

Contact information is provided by the study sponsor or research team.

GİZEM CANSIZ UÇAR, Registered Nurse

CONTACT

[email protected]

+905342396480

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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