The Effect of Virtual Reality on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy
1 other identifier
interventional
66
1 country
1
Brief Summary
It was aimed to determine the effect of virtual reality glasses application on anxiety and fatigue in women with breast cancer receiving adjuvant chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedStudy Start
First participant enrolled
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedMarch 23, 2023
March 1, 2023
8 months
December 9, 2021
March 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
State Anxiety Scale
The mean anxiety scores of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 20 points and a maximum of 80 points are taken from the scale. The higher the score, the higher the anxiety.
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
The mean fatigue scores of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 15 points and a maximum of 60 points are taken from the scale. The higher the score, the higher the fatigue.
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Secondary Outcomes (3)
Cancer Fatigue Scale
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Cancer Fatigue Scale
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Study Arms (2)
Virtual Reality in Women with Breast Cancer
EXPERIMENTALIt is planned to pre-test, wear virtual reality glasses and post-test before chemotherapy for breast cancer women who will receive adjuvant treatment for the first time, who agree to participate in the study. This follow-up will be done 3 more times, and each cure will be followed for 4 cures. It will be ensured that the patients fill out the State Anxiety Scale and Cancer Fatigue Scale as a pre-test and post-test. After the chemotherapy infusion starts, the patient will listen and watch the relaxing beach and nature content with 360 degrees for 30 minutes with virtual reality glasses attached to the patient.
Standard Care in Women with Breast Cancer
NO INTERVENTIONWomen with breast cancer who will receive adjuvant treatment for the first time, who agree to participate in the study, will be pre-tested before chemotherapy and a post-test will be performed 30 minutes after the start of chemotherapy treatment by the nurse. This follow-up will be done 3 more times, and each cure will be followed for 4 cures. It will be ensured that the patients fill out the State Anxiety Scale and Cancer Fatigue Scale as a pre-test and post-test.
Interventions
Eligibility Criteria
You may qualify if:
- Those between the ages of 18 - 65
- Those who are women
- Those who were diagnosed with breast cancer for the first time and received adjuvant chemotherapy treatment
- Patients receiving the protocol with Cyclophosphamide, Doxorubicin (Adriamycin)
- Those who know that they have breast cancer
- Those with the least education level who are literate
- Those who agreed to participate in the study
- Those who speak and understand Turkish
You may not qualify if:
- Those receiving neoadjuvant chemotherapy treatment
- Those with metastases
- Recurrent (Recurrent) ones
- Those who use psychiatric drugs
- Those with a history of seizures
- Those with communication problems (hearing, seeing, speaking, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necmettin Erbakan University of Nursing Faculty
Meram, Konya, 42020, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arzu USLU, RN, MS, PhD(c), Instructor
Necmettin Erbakan University Faculty of Nursing
- PRINCIPAL INVESTIGATOR
Selda ARSLAN, Assoc. Prof.
Necmettin Erbakan University Faculty of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, MS, PhD(c), Instructor
Study Record Dates
First Submitted
December 9, 2021
First Posted
December 23, 2021
Study Start
April 4, 2022
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
March 23, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share