Effect of Virtual Reality on Caregivers of Palliative Care Patients

NCT ID: NCT05742555

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Due to advances in medical technology and accessible health services, the prognosis of diseases has improved and the need for care has increased, and primary caregivers have experienced the increased burden of caring for family members for a long time.

Because the patient is primarily responsible for continuing patient care in palliative care units and then at home, and especially because they have problems in psychological, social and financial support, caregivers within the family are considered as second-degree patients or occult patients.

Studies have shown that caregivers have a significant burden of care, therefore they experience serious depression, anxiety and physical problems, isolate themselves from society, and their quality of life decreases significantly.

In recent years, the use of virtual reality, which shows itself in different application areas in the field of health as a safe and useful system, has become widespread. Considering the use of virtual reality in the field of health; It is seen that it is mostly preferred for pain management, physical condition improvement, blood collection, burn treatment, and psychological disorder.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Palliative care; It is a multidisciplinary approach that includes interventions to prevent complications and improve the quality of life of people with severe illness. Regardless of the level of development, palliative care units provide service in all countries.

The World Health Organization (WHO) stated that the aim of palliative care is not only to improve the quality of life of patients but also to support caregivers. Care burden is defined as negative subjective and objective consequences such as physical health problems, psychological distress, economic and social problems, deterioration of family relationships and loss of control.

The caregiver feels obliged to provide the patient's treatment, personal care and psychosocial support. The physical, economic and moral burden on the caregiver can negatively affect the caregiver socially, psychologically and physically over time.

Caregivers of palliative care patients have an important responsibility. The relationship between providing care and receiving care is in a delicate balance. caring for the patient; it turns into a dependent, intense, long-term and unilateral obligation. These adversely affect the caregiver's quality of life. In addition to the problems of patient care, caregivers also experience problems such as physical problems, fatigue, sleep disorders, behavioral changes, and loss of social roles. As a result, psychological and emotional disorders may occur in the caregiver. Eliminating the symptoms experienced by the caregiver and improving their quality of life are very important in the caregiving process.

The concept of virtual reality is defined as the combination of reality and imagination by transferring various realities to digital media and using special technological devices thanks to technological tools. The use of virtual reality in the field of health has become widespread and can be used for different purposes. Virtual reality application is most commonly used in patients for pain management, exercise training, burn treatments and psychological disorders. Looking at the literature, watching nature scenes; It has been observed that it reduces blood pressure and heart rate and respiratory rate in people, reduces stress and brain activity, and provides relaxation. No study has been found in the literature on caregivers who underwent virtual reality intervention. In this study, it is aimed to increase the mental well-being and quality of life of the relatives of patients who care for palliative care patients with virtual reality application.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Well-being Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

Group Type EXPERIMENTAL

Virtual reality intervention

Intervention Type OTHER

After the relatives of the patients included in the experimental group are informed about the study, they will be asked to fill in the Participant Information Form, Nottingham Health Profile (NSP) and Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ) after obtaining their permission. The virtual reality intervention will be applied to the caregivers at a suitable time of the day (when the patient's care and treatment is not intensive, the caregiver wishes). Different nature scenes (sea, forest, stream) with different types of music (classical music, nature sounds, relaxing music) will be watched for 10 minutes, 3 days a week. The application will be made for 4 weeks. At the end of this period, they will be asked to fill the NSP and WEMİOÖ again as a final test.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual reality intervention

After the relatives of the patients included in the experimental group are informed about the study, they will be asked to fill in the Participant Information Form, Nottingham Health Profile (NSP) and Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ) after obtaining their permission. The virtual reality intervention will be applied to the caregivers at a suitable time of the day (when the patient's care and treatment is not intensive, the caregiver wishes). Different nature scenes (sea, forest, stream) with different types of music (classical music, nature sounds, relaxing music) will be watched for 10 minutes, 3 days a week. The application will be made for 4 weeks. At the end of this period, they will be asked to fill the NSP and WEMİOÖ again as a final test.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Over 18 years old
* Having the ability to read, understand and write Turkish,
* Does not have any psychiatric disorder and does not use drugs for it,
* Having a history of seizures,
* No migraine, vertigo, active nausea, vomiting, headache

Exclusion Criteria

-Individuals with epilepsyIndividuals with vertigo
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seda Karaman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B.30.2.ATA.0.01.00/451

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality at End-of-life
NCT06149429 COMPLETED NA
Bringing Life to Those Near Death
NCT05466123 ENROLLING_BY_INVITATION NA