NCT05742555

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

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

February 3, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 3, 2023

Last Update Submit

February 14, 2023

Conditions

Keywords

palliative carecaregivermental well-beingquality of lifevirtual reality

Outcome Measures

Primary Outcomes (2)

  • Edinburgh Mental Well-Being Scale

    Warwick-Edinburgh Mental Well-Being Scale (WEMIOÖ): WEMİOOS 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

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL
Other: Virtual reality intervention

Control Group

NO INTERVENTION

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with epilepsyIndividuals with vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 24, 2023

Study Start

February 20, 2023

Primary Completion

June 20, 2023

Study Completion

August 20, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02