- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907070
Mandala Art and Value Clarification With Parents of Children With Cancer
The Effect of Mandala Art and Value Clarification Based on Watson's Theory of Human Caring on the Anxiety and Mood of Parents of Children With Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The population of the study consists of the parents of children diagnosed with cancer in the Akdeniz University Hospital Pediatric Hematology and Oncology Clinic. The sample of the study is three groups; intervention 1 group (n:25), intervention 2 group (n:25) and control group (n:25) will consist of a total of 75 parents. A closed envelope system with simple randomization will be used in sample selection.
Intervention 1 group will participate in 2 sessions of individual mandala drawing art activity with the theme of 'Emotions' accompanied by classical or instrumental music. In each session, a mandala will be created. Intervention 2 groups will participate in the value clarification activity by writing 2 sessions individually with the theme of 'Emotions' accompanied by classical or instrumental music. Personal Information Form, State Anxiety Inventory and Positive-Negative Affect Scale were administered to the intervention groups at the first meeting in order to collect pre-test data. To collect post-test data, the State Anxiety Inventory and the Positive-Negative Affect Scale were administered immediately after the second session. No intervention will be made to the control group, the same data collection tools were applied to the intervention groups.
In addition, Iin the second session, the parent was asked to interpret the colors and shapes in the mandala created by the parent and a face-to-face interview was held.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey, 07070
- Meltem Gürcan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having the ability to read, write, speak and understand Turkish
- Being the parent of a 0-17-year-old child diagnosed with cancer
- Staying in the hospital with child
- Being hospitalized for at least the second course of treatment of the child
Exclusion Criteria:
- Having a physical problem that may prevent you from drawing and typing a mandala and participating in value clarification
- Not being able to take a break from caring for their child and participate in individual activities
- Having the child in the terminal period
- Relapse disease of the child
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Routine nursing care
|
|
|
Experimental: Mandala group
Mandala drawing and coloring on paper
|
Mandala group will participate in 2 sessions of individual mandala drawing art activity with the theme of 'Emotions' accompanied by classical or instrumental music.
In each session, a mandala will be created.
|
|
Experimental: Value clarification group
Value clarification by writing on paper
|
Value clarification groups will participate in the value clarification activity by writing 2 sessions individually with the theme of 'Emotions' accompanied by classical or instrumental music.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive-Negative Affect Scale (PANAS)
Time Frame: pre-test
|
The scale consists of 20 items, 10 of which are positive and 10 of which are negative, describing various emotions.
The scale has 2 sub-dimensions: positive and negative affect.
|
pre-test
|
|
State Anxiety Inventory (STAI)
Time Frame: pre-test
|
The State Anxiety Inventory is a 4-point Likert-type scale consisting of 20 items.
According to the level of life of individuals; It is answered by marking one of the options such as (1) not at all, (2) a little, (3) a lot, (4) completely.
|
pre-test
|
|
Positive-Negative Affect Scale (PANAS)
Time Frame: 2 or 3 days after pre-test
|
The scale consists of 20 items, 10 of which are positive and 10 of which are negative, describing various emotions.
The scale has 2 sub-dimensions: positive and negative affect.
|
2 or 3 days after pre-test
|
|
State Anxiety Inventory (STAI)
Time Frame: 2 or 3 days after pre-test
|
The State Anxiety Inventory is a 4-point Likert-type scale consisting of 20 items.
According to the level of life of individuals; It is answered by marking one of the options such as (1) not at all, (2) a little, (3) a lot, (4) completely.
|
2 or 3 days after pre-test
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Sevcan ATAY TURAN, PhD, Assistant Professor
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
Keywords
Other Study ID Numbers
- 2023.9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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