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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05742555
Other study ID # B.30.2.ATA.0.01.00/451
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date August 20, 2023

Study information

Verified date February 2023
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 20, 2023
Est. primary completion date June 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 WEMIOÖ again as a final test.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Outcome

Type Measure Description Time frame Safety issue
Primary Edinburgh Mental Well-Being Scale Warwick-Edinburgh Mental Well-Being Scale (WEMIOƖ): WEMIOOS consists of 14 items and deals with the positive mental health of individuals, including psychological well-being and subjective well-being. A minimum of 14 points and a maximum of 70 points are taken from the scale. Higher scores mean higher psychological well-being. The scale is a 5-point Likert scale: "5: I totally agree, 4: I agree, 3: I somewhat agree, , 2: I don't agree, 1: I don't agree at all". All items of the scale are positive. through study completion, an average of 7 months
Primary Nottingham Health Profile (NSP) Nottingham Health Profile (NSP): It measures the health-related quality of life of individuals and the effect of their problems on social role functions. The first part of the scale with 38 items covers quality of life; The second part of 6 items measures the effects of problems on their functions in social roles. The first and second parts of the scale can be used independently of each other. In this study, the first part of the scale, consisting of 38 items and evaluating the quality of life answered as yes-no by the individual, will be used. It consists of 6 sub-dimensions: physical movement, sleep, pain, energy, emotional reactions and social isolation. The score of each sub-dimension ranges from 0-100. The total score is obtained by summing the scores of the 6 sub-dimensions. High scores indicate poor quality of life. through study completion, an average of 7 months
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