AnxietyMandalaNCT06180343
The Effect of Mandala Coloring on Students' Anxiety Level and Quality of Life
A study testing Mandala in people with Anxiety, run by Kırklareli University.
Trial summary
Anxiety is a mood that focuses on the future, related to being prepared for possible upcoming negative events (fear, pain or danger), and unlike fear, its object is not determined or recognized, and it is exposed to uncertainty. Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Mandala
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2024to 20 Apr 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 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuing her education at the Midwifery Department of the Faculty of Health Sciences
- Volunteering to participate in the study
- Knowing Turkish (being literate)
Who cannot join
- Having diagnosed psychiatric diseases,
- STAI anxiety score ≤36 (non-anxious)
- Having previously received non-pharmacological or pharmacological treatment
Trial locations and contacts
No sites are listed yet.
About this study
Anxiety is a mood that focuses on the future, related to being prepared for possible upcoming negative events (fear, pain or danger), and unlike fear, its object is not determined or recognized, and it is exposed to uncertainty. Art therapy is used in the clinical and rehabilitation field as a useful tool for self-expression, healing and well-being. The close relationship between art, healing and well-being, and the therapeutic power of art has long been accepted all over the world.Many studies have been conducted in the literature examining the effect of mandala painting on reducing anxiety.This proposed project was planned to be carried out as a quasi-experimental study, based on the idea that mandala painting can reduce the level of anxiety in students and have a positive effect on the quality of life.
Read the detailed description
Anxiety is a mood that focuses on the future, related to being prepared for possible upcoming negative events (fear, pain or danger), and unlike fear, its object is not determined or recognized, and it is exposed to uncertainty. Anxiety, which is felt as a common worry especially related to feelings of helplessness, is handled in two ways: state anxiety, which occurs in certain situations, and trait anxiety, which continues regardless of a specific situation.
Art therapy is used in the clinical and rehabilitation field as a useful tool for self-expression, healing and well-being. The close relationship between art, healing and well-being, and the therapeutic power of art has long been accepted all over the world. In line with developments in mental health since the mid-twentieth century, art has been widely appreciated as an important tool for both diagnosis and treatment. Art therapy offers individuals a safe haven to get away from past experiences and difficulties that no longer cause harm. In this context, there are many studies highlighting the effect of art therapy on psychological disorders such as healing trauma, death anxiety and burnout, showing that art therapy can be used as an alternative therapy in the treatment of emotion regulation and psychological disorders.
It is assumed that the repetitive patterns and symmetry of the mandala, which means circle in Sanskrit, create a meditative effect and increase psychological well-being by developing awareness. The anxiety-reducing effect of mandala, an integrative body-mind education form, has been associated with the circle; It is believed to increase psychological adaptation and preserve personality integrity, and is still used in psychotherapies today. Many studies have been conducted in the literature examining the effect of mandala painting on reducing anxiety.
When domestic and international literature is examined, it is noteworthy that there are no studies evaluating whether mandala painting reduces students' anxiety levels and increases their quality of life. This proposed project was planned to be carried out as a quasi-experimental study, based on the idea that mandala painting can reduce the level of anxiety in students and have a positive effect on the quality of life.
- Conditions
- Anxiety
- Being tested
- Mandala
- Keywords
- Mandala coloring, Stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MandalaOther
Participants will be asked to choose the pages they want from the 12 colored felt-tip pen paint sets and mandala coloring book given to each participant by the researcher, and color them in the colors they want, for 6 weeks, once a week, at any time of the day and for an average of 20-30 minutes each time.
Participants will be asked to send a message before they start painting the mandala, and after the process, they will be asked to take a picture of the mandala they have painted and send it to the researcher. If the participants forget to color the mandala, a reminder message will be sent by the researcher twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Mandala coloring group | Experimental | Participants will be asked to choose the pages they want from the 12 colored felt-tip pen paint sets and mandala coloring book given to each participant by the researcher, and color them in the colors they want, for 6 weeks, once a week, at any time of the day and for an average of 20-30 minutes each time.
Participants will be asked to send a message before they start painting the mandala, and after the process, they will be asked to take a picture of the mandala they have painted and send it to the researcher. If the participants forget to color the mandala, a reminder message will be sent by the researcher twice a week. Receives: Other: Mandala |
| Control group | No intervention | Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms. Participants will be asked by telephone by the researcher twice a week for 6 weeks whether they have taken any action to reduce their anxiety symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce anxiety symptoms will be excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
The form consists of questions about socio-demographic
Measured: 1 week
Secondary outcomes (2)
World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF-TR)
The scale includes 27 questions in four areas: physical health, psychological health, social relations and environment. Questions are answered taking into account the last 15 days.
Measured: 6 weeks
State-trait anxiety inventory
The State Anxiety Scale, which consists of twenty items, requires individuals to describe how they feel at a certain moment under certain conditions and to answer the items by taking into account their feelings about the situation. The total score obtained from the scale is between minimum 20 and maximum 80. Higher score it's mean worse.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start30 Jan 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomize controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- AYCA SOLT KIRCA, Phd, Study director, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180343
- Sponsor's protocol ID
- KırklareliAS-8
- Acronym
- Mandala
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Students' Anxiety Level and Quality of Life
- ClinicalTrials.gov ID
- NCT06180343
- Acronym / sponsor ID
- Mandala / KırklareliAS-8
- Conditions
- Anxiety
- Keywords
- Mandala coloring, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 22 Dec 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.
Anxiety is a mood that focuses on the future, related to being prepared for possible upcoming negative events (fear, pain or danger), and unlike fear, its object is not determined or recognized, and it is exposed to uncertainty. Art therapy is used in the clinical and rehabilitation field as a useful tool for self-expression, healing and well-being. The close relationship between art, healing and well-being, and the therapeutic power of art has long been accepted all over the world.Many studies have been conducted in the literature examining the effect of mandala painting on reducing anxiety.This proposed project was planned to be carried out as a quasi-experimental study, based on the idea that mandala painting can reduce the level of anxiety in students and have a positive effect on the quality of life.
Detailed description
Anxiety is a mood that focuses on the future, related to being prepared for possible upcoming negative events (fear, pain or danger), and unlike fear, its object is not determined or recognized, and it is exposed to uncertainty. Anxiety, which is felt as a common worry especially related to feelings of helplessness, is handled in two ways: state anxiety, which occurs in certain situations, and trait anxiety, which continues regardless of a specific situation.
Art therapy is used in the clinical and rehabilitation field as a useful tool for self-expression, healing and well-being. The close relationship between art, healing and well-being, and the therapeutic power of art has long been accepted all over the world. In line with developments in mental health since the mid-twentieth century, art has been widely appreciated as an important tool for both diagnosis and treatment. Art therapy offers individuals a safe haven to get away from past experiences and difficulties that no longer cause harm. In this context, there are many studies highlighting the effect of art therapy on psychological disorders such as healing trauma, death anxiety and burnout, showing that art therapy can be used as an alternative therapy in the treatment of emotion regulation and psychological disorders.
It is assumed that the repetitive patterns and symmetry of the mandala, which means circle in Sanskrit, create a meditative effect and increase psychological well-being by developing awareness. The anxiety-reducing effect of mandala, an integrative body-mind education form, has been associated with the circle; It is believed to increase psychological adaptation and preserve personality integrity, and is still used in psychotherapies today. Many studies have been conducted in the literature examining the effect of mandala painting on reducing anxiety.
When domestic and international literature is examined, it is noteworthy that there are no studies evaluating whether mandala painting reduces students' anxiety levels and increases their quality of life. This proposed project was planned to be carried out as a quasi-experimental study, based on the idea that mandala painting can reduce the level of anxiety in students and have a positive effect on the quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomize controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mandala coloring group | Experimental | Other: MandalaParticipants will be asked to choose the pages they want from the 12 colored felt-tip pen paint sets and mandala coloring book given to each participant by the researcher, and color them in the colors they want, for 6 weeks, once a week, at any time of the day and for an average of 20-30 minutes each time. Participants will be asked to send a message before they start painting the mandala, and after the process, they will be asked to take a picture of the mandala they have painted and send it to the researcher. If the participants forget to color the mandala, a reminder message will be sent by the researcher twice a week. |
| Control group | No intervention | –Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms. Participants will be asked by telephone by the researcher twice a week for 6 weeks whether they have taken any action to reduce their anxiety symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce anxiety symptoms will be excluded from the study. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Continuing her education at the Midwifery Department of the Faculty of Health Sciences
- Volunteering to participate in the study
- Knowing Turkish (being literate)
Key exclusion criteria (3 listed)
- Having diagnosed psychiatric diseases,
- STAI anxiety score ≤36 (non-anxious)
- Having previously received non-pharmacological or pharmacological treatment
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 |
|---|---|---|
| MandalaParticipants will be asked to choose the pages they want from the 12 colored felt-tip pen paint sets and mandala coloring book given to each participant by the researcher, and color them in the colors they want, for 6 weeks, once a week, at any time of the day and for an average of 20-30 minutes each time. Participants will be asked to send a message before they start painting the mandala, and after the process, they will be asked to take a picture of the mandala they have painted and send it to the researcher. If the participants forget to color the mandala, a reminder message will be sent by the researcher twice a week. | Other | Mandala coloring group |
Primary outcome
Introductory Information Form
Time frame: 1 week
The form consists of questions about socio-demographic
2 secondary outcomes
World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF-TR)
Time frame: 6 weeks
State-trait anxiety inventory
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 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.
AYCA SOLT KIRCA, Phd study director
Kırklareli University
Questions about this trial
What is this clinical trial studying?
A study testing Mandala in people with Anxiety, run by Kırklareli University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AYCA SOLT KIRCA, Phd (+905392684185, aycasolt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: 1 week). 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 30 Jan 2024.