Nursing CariesNCT05907070
Mandala Art and Value Clarification With Parents of Children With Cancer
A study testing Mandala group and Value clarification group in people with Nursing Caries, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The research is planned to be conducted with a randomized controlled experimental study. In the research, it is aimed to determine the effect of mandala drawing art and value clarification application based on Watson Human Care Theory on the anxiety and mood of the parents of children with cancer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Mandala group and Value clarification group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The research is planned to be conducted with a randomized controlled experimental study. In the research, it is aimed to determine the effect of mandala drawing art and value clarification application based on Watson Human Care Theory on the anxiety and mood of the parents of children with cancer.
Read the 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.
- Conditions
- Nursing Caries
- Being tested
- Mandala group, Value clarification group
- Keywords
- child, value clarification, parent, cancer, mandala, art therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala groupOther
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.
Value clarification groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mandala group | Experimental | Mandala drawing and coloring on paper Receives: Other: Mandala group |
| Value clarification group | Experimental | Value clarification by writing on paper Receives: Other: Value clarification group |
| Control group | No intervention | Routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive-Negative Affect Scale (PANAS)
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.
Measured: pre-test
Positive-Negative Affect Scale (PANAS)
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.
Measured: 2 or 3 days after pre-test
State Anxiety Inventory (STAI)
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.
Measured: pre-test
State Anxiety Inventory (STAI)
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.
Measured: 2 or 3 days after pre-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Apr 2023
- Primary completion15 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, Meltem Gürcan, Akdeniz University
- Investigators
- Sevcan ATAY TURAN, PhD, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907070
- Sponsor's protocol ID
- 2023.9
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05907070
- Acronym / sponsor ID
- 2023.9
- Conditions
- Nursing Caries
- Keywords
- child, value clarification, parent, cancer, mandala, art therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research is planned to be conducted with a randomized controlled experimental study. In the research, it is aimed to determine the effect of mandala drawing art and value clarification application based on Watson Human Care Theory on the anxiety and mood of the parents of children with cancer.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mandala group | Experimental | Other: Mandala groupMandala drawing and coloring on paper |
| Value clarification group | Experimental | Other: Value clarification groupValue clarification by writing on paper |
| Control group | No intervention | –Routine nursing care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala groupMandala 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. | Other | Mandala group |
| Value clarification groupValue 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. | Other | Value clarification group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevcan ATAY TURAN, PhD study director
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala group and Value clarification group in people with Nursing Caries, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive-Negative Affect Scale (PANAS) (time frame: pre-test). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.