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The Effect of Virtual Reality on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy

Primary Purpose

Breast Cancer Female, Anxiety, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Glasses
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female focused on measuring Virtual reality, Distraction, Anxiety, Fatigue, Nursing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

Sites / Locations

  • Necmettin Erbakan University of Nursing Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality in Women with Breast Cancer

Standard Care in Women with Breast Cancer

Arm Description

It 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.

Women 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Cancer Fatigue Scale
The physical function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 7 points and a maximum of 28 points are taken from the scale. As the score increases, physical fatigue increases.
Cancer Fatigue Scale
The emotional function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 4 points and a maximum of 16 points are taken from the scale. Emotional fatigue increases as the score increases.
Cancer Fatigue Scale
The cognitive function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 4 points and a maximum of 16 points are taken from the scale. As the score increases, cognitive fatigue increases.

Full Information

First Posted
December 9, 2021
Last Updated
March 21, 2023
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT05168696
Brief Title
The Effect of Virtual Reality on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy
Official Title
The Effect of Virtual Reality Glasses Application on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy: Pretest-Posttest Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The number of women with breast cancer worldwide is increasing day by day. Uncertainty of the efficacy of treatment, difficulty in accepting the disease, financial difficulties, insomnia, fear and anxiety about the future, concentration disorder, feeling angry, focusing on thoughts of illness and death, irregularities in work and family life, emergence of treatment Their quality of life is adversely affected due to many conditions such as worrying about side effects and loss of appetite. The disease process should be managed correctly before these symptoms related to treatment occur in patients. Anxiety and fatigue are the leading symptoms that limit the activities of daily living and significantly affect the social lives of patients receiving chemotherapy for the first time after the diagnosis of breast cancer. 46%-71% of patients diagnosed with cancer experience anxiety and 80%-90% fatigue during chemotherapy. Nurses, who are health professionals, use non-pharmacological methods as well as pharmacological methods in the prevention and management of symptoms during the chemotherapy treatment process. Non-pharmacological methods include practices such as meditation, yoga, hypnosis, prayer, relaxation techniques, daydreaming, and cognitive behavioral therapies that involve distraction. With these cognitive behavioral therapies, nurses aim to strengthen the self-care of cancer patients, increase adherence to the disease, develop effective coping methods, manage chemotherapy-related side effects, and increase hope and belief. With the method of distraction, which is frequently used from cognitive behavioral therapies, it is aimed to focus on another stimulus and to get away from negative feelings and thoughts. Recently, virtual reality application has been used frequently in the field of health for the method of distraction. Virtual reality is defined as the human computer interface that makes it feel as if it is in another universe with tools. The three-dimensional screen provides the attention of the person with the virtual reality stimuli with the motion detection system. The virtual reality application that attracts attention is preferred because it is a non-invasive intervention, has an affordable cost, and is effective in the motivation and well-being of the individual. In the meta-analysis of cancer-related symptom management, virtual reality applications, which do not require any special training, were found to increase tolerance to chemotherapy, to be effective in symptom management, to increase quality of life, and to enable acceptance of chronic disease. In the study, it was also stated that virtual reality applications were effective in reducing anxiety, depression, pain and cognitive function symptoms, although not effective in reducing fatigue, it was beneficial, and no serious side effects were reported. It is seen that the studies were designed as a single-time measurement, non-randomized research design, and a single-group pre-test-post-test. In this study, which aims to evaluate the effect of virtual reality glasses application on anxiety and fatigue in women with breast cancer receiving adjuvant chemotherapy, it is planned to increase the level of evidence of virtual reality glasses application by making multiple measurements and to evaluate fatigue with physical, emotional and cognitive sub-dimensions. In addition, this study is important in terms of increasing the awareness of oncology nurses who care for breast cancer patients about virtual reality application and integrating the method of distraction with virtual reality application into standard care. It is thought that it is useful and appropriate for the nurse to manage the distraction method with the virtual reality application, which is a non-invasive intervention, does not require specific skills, and has no serious side effects. For this purpose, it was planned to determine the effect of virtual reality glasses application on anxiety and fatigue in women with breast cancer receiving adjuvant chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Anxiety, Fatigue
Keywords
Virtual reality, Distraction, Anxiety, Fatigue, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality in Women with Breast Cancer
Arm Type
Experimental
Arm Description
It 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.
Arm Title
Standard Care in Women with Breast Cancer
Arm Type
No Intervention
Arm Description
Women 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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Glasses
Intervention Description
Virtual Reality Glasses
Primary Outcome Measure Information:
Title
State Anxiety Scale
Description
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.
Time Frame
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Title
Cancer Fatigue Scale
Description
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.
Time Frame
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Secondary Outcome Measure Information:
Title
Cancer Fatigue Scale
Description
The physical function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 7 points and a maximum of 28 points are taken from the scale. As the score increases, physical fatigue increases.
Time Frame
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Title
Cancer Fatigue Scale
Description
The emotional function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 4 points and a maximum of 16 points are taken from the scale. Emotional fatigue increases as the score increases.
Time Frame
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.
Title
Cancer Fatigue Scale
Description
The cognitive function sub-dimension mean scores of fatigue of virtual reality glasses application in women with breast cancer receiving adjuvant chemotherapy are different from the control group. A minimum of 4 points and a maximum of 16 points are taken from the scale. As the score increases, cognitive fatigue increases.
Time Frame
1st cure, 2nd cure, 3rd cure, 4th cure, Each cure is given every 21 days.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu USLU, RN, MS, PhD(c), Instructor
Organizational Affiliation
Necmettin Erbakan University Faculty of Nursing
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Selda ARSLAN, Assoc. Prof.
Organizational Affiliation
Necmettin Erbakan University Faculty of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University of Nursing Faculty
City
Meram
State/Province
Konya
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Virtual Reality on Anxiety and Fatigue in Women With Breast Cancer Receiving Adjuvant Chemotherapy

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