- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06382714
Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients
Efects of Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sivas
-
Mollaoğlu, Sivas, Turkey (Türkiye), 58140
- Mukadder
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients who have been receiving hemodialysis treatment for at least one year, who are 18 years of age or older, who do not have difficulty in communicating, who are competent to answer all the questions, who do not have serious mental illness or mental problems, and who agree to participate in the research will be included in the study.
Exclusion Criteria:
Those who have just started hemodialysis treatment (< 1 year), those who have vision or hearing problems, those who have difficulty communicating, those under the age of 18, and those who do not want to participate in the study or want to leave will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Art Therapy Intervention Group
A total of five sessions of museum visits will applied to the patients in the intervention group, lasting 20-30 minutes during dialysis. The scales will administered to the individuals in the intervention groups three times in total. The intervention group is the group in which museum visit will applied. They receives 3 sessions of hemodialysis per week. |
Patients will visit a museum while undergoing hemodialysis with virtual reality glasses for a total of five sessions for intervention group
|
|
No Intervention: Control Group
No virtual museum visit was applied to the control group.
Scales were applied to individuals.
For the control group, evaluations were made with scales three times in total.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dialysis Symptom Index (DSI)
Time Frame: It will take 5 weeks to collect data three times after randomization is done. The first measurement of dialyis symptom index will be done in the first week, the second measurement in the third week and the third measurement in the fifth week.
|
It was developed by HD patients in order to determine the symptoms experienced by HD patients and the level of impact on the patient.
The scale, developed from the Memorial Symptom Diagnosis Scale Short Form, consists of 30 items.
Responses are obtained on a 5-point Likert scale.
The total scale score is obtained by adding up the scores obtained.
This value varies between "0-15 0".
The value "0" indicates that there is no symptom.
The increase in the total points given to the answers towards 150 points shows that the effect of the mentioned symptom is increasing.
The internal consistency coefficient of the scale was determined as 0.84.
|
It will take 5 weeks to collect data three times after randomization is done. The first measurement of dialyis symptom index will be done in the first week, the second measurement in the third week and the third measurement in the fifth week.
|
|
Beck Anxiety Scale (BAI)
Time Frame: It will take 5 weeks to collect data three times after randomization is done. The first measurement of Beck anxiety scale will be done in the first week, the second measurement in the third week and the third measurement in the fifth week.
|
It measures the frequency of anxiety symptoms experienced by the individual.
It is a Likert-type self-evaluation scale consisting of twenty-one items and scored between 0-3.
A high total score indicates the level of anxiety experienced by the person.
The validity and reliability of the scale was determined in our country.
|
It will take 5 weeks to collect data three times after randomization is done. The first measurement of Beck anxiety scale will be done in the first week, the second measurement in the third week and the third measurement in the fifth week.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- Weisbord SD, Fried LF, Arnold RM, Rotondi AJ, Fine MJ, Levenson DJ, Switzer GE. Development of a symptom assessment instrument for chronic hemodialysis patients: the Dialysis Symptom Index. J Pain Symptom Manage. 2004 Mar;27(3):226-40. doi: 10.1016/j.jpainsymman.2003.07.004.
- Ulusoy M, Şahin N, Erkman H. Turkish Version of The Beck Anxiety Inventory: psychometric Properties. J Cognitive Psychotherapy: Int Quaterly. 1998; 12: 28-35.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-12/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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