Mandala PaintingNCT07109492
The Role of Mandala Painting Before Surgery
A study testing Mandala in people with Mandala Painting and Surgery, run by Niran Çoban at 1 site in Turkey (Türkiye).
Trial summary
Surgical interventions often cause significant anxiety and stress in patients during the preoperative period. In this study, it is aimed to determine the effect of mandala coloring, a non-pharmacological and art-based intervention, on reducing anxiety and stress levels in individuals scheduled for elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandala Painting, Surgery, Nurse's Role
- What is being tested?
- Mandala
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Nov 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are undergoing elective surgery,
- Cholecystectomy Surgery is planned
- Age 18 and over,
- Able to communicate,
- No wounds or injuries on their hands that would prevent them from painting,
- Volunteer to participate in the study.
Who cannot join
- Individuals with a previous psychiatric diagnosis,
- Those with color blindness or visual perception disorders, Patients over 70 years of age
- Those taking tranquilizers (anxiolytics, antidepressants, etc.),
- Those with any health problems that may prevent them from painting (fractures, amputations, etc.),
- Those who are illiterate,
- Those with communication disabilities will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Mandala Painting Before Surgery on Anxiety and Stress
Surgical interventions often cause significant anxiety and stress in patients during the preoperative period. In this study, it is aimed to determine the effect of mandala coloring, a non-pharmacological and art-based intervention, on reducing anxiety and stress levels in individuals scheduled for elective surgery. The universe of the study will consist of patients who will undergo elective surgery between June 2025 and June 2026 in the General Surgery Clinic of Istanbul Sultangazi Training and Research Hospital. Data will be collected using the Introductory Information Form, State Anxiety Inventory (STAI-S), Perceived Stress Scale (PSS), and Physiological Parameters Form (including blood pressure, pulse, respiration rate, and oxygen saturation). One day before surgery, patients who meet the inclusion criteria will be informed about the study and randomized into intervention and control groups using a random number table created with MS Excel software. Patients in the intervention group will perform a 20-minute mandala coloring activity in the preoperative waiting period. Before and after the application, participants' anxiety and stress levels will be evaluated with the STAI-S and PSS, and their physiological parameters will be recorded. Patients in the control group will receive standard preoperative care and will be evaluated at the same time points with the same tools, without any intervention. The study aims to provide evidence for the use of mandala coloring as a simple, low-cost, and effective nursing intervention to reduce preoperative anxiety and stress.
Read the detailed description
Surgical procedures, although often lifesaving and necessary, are known to trigger significant levels of psychological distress, particularly in the preoperative period. This phase, characterized by uncertainty, fear of anesthesia, and concerns about postoperative outcomes, commonly leads to increased levels of anxiety and stress. Preoperative anxiety is reported in up to 85% of surgical patients and is associated with adverse outcomes such as elevated pain perception, delayed recovery, higher analgesic needs, increased cardiac complications, and lower patient satisfaction. While pharmacological approaches are commonly used, there is growing interest in non-pharmacological and holistic strategies to manage preoperative anxiety and stress effectively.
Among the emerging non-drug interventions, art-based therapeutic activities have gained attention due to their accessibility, affordability, and psychological benefits. One such method is mandala coloring, which involves filling in structured circular designs using colors of the participant's choice. The term "mandala" originates from Sanskrit, meaning "circle," and symbolizes wholeness and balance. According to Carl Jung, mandalas help individuals center themselves and connect with their inner states, offering a calming and integrative experience.
Mandala coloring has been shown to reduce stress and anxiety by directing attention to the present moment, promoting mindfulness, and eliciting meditative-like states. Unlike traditional art therapy, mandala coloring does not require artistic skill and can be easily implemented across various age and educational levels. Studies suggest that coloring mandalas decreases cortisol levels, improves emotional regulation, and enhances psychological well-being in different populations.
Despite its recognized benefits in mental health contexts, limited research exists on the use of mandala coloring specifically in surgical patients during the preoperative period. This study aims to fill this gap by evaluating the effect of a short, structured mandala coloring session on anxiety, stress, and selected physiological parameters among patients awaiting elective surgery.
The study will be conducted between June 2025 and June 2026 at Istanbul Sultangazi Training and Research Hospital's General Surgery Clinic. A total of 60 adult patients who meet the inclusion criteria will be recruited and randomly assigned to either the Mandala Coloring Group (intervention) or the Standard Care Group (control) using a random number table created in MS Excel.
On the day before surgery, participants will be informed about the study and will provide written informed consent. Baseline data will be collected using the Introductory Information Form, the State Anxiety Inventory (STAI-S), the Perceived Stress Scale (PSS), and a Physiological Parameters Form, which includes systolic and diastolic blood pressure, pulse rate, respiratory rate, and oxygen saturation.
Patients in the intervention group will engage in a 20-minute mandala coloring activity using standardized coloring sets in a quiet, preoperative room. Those in the control group will receive routine preoperative care in the same setting, without any additional intervention. Following the intervention period, all participants will undergo the same post-test measurements using the aforementioned tools.
By targeting both psychological and physiological indicators, this study aims to demonstrate that mandala coloring is a practical, low-cost, non-pharmacological approach that can be effectively integrated into routine preoperative nursing care. The findings are expected to contribute to evidence-based surgical nursing practices and support the inclusion of creative, holistic methods in the preparation of patients for surgery.
- Conditions
- Mandala Painting, Surgery, Nurse's Role
- Being tested
- Mandala
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MandalaOther
Mandala Painting
| Study group | Role | What they receive |
|---|---|---|
| Mandala painting | Experimental | Pre-surgery (Before Mandala Painting) Pre-surgery (After Mandala Painting - 20 minutes later) Receives: Other: Mandala |
| Standard care | No intervention | Since standard care will be applied to the patients in this group, in order to be parallel with the mandala group, the relevant scale questions will be answered by interviewing the patient 20 minutes before and after going to the operating room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Mandala Painting on Anxiety
State Anxiety Inventory: In this study, the "State Anxiety Inventory (STAI-I)" will be used before and after the mandala coloring to assess patients' situational anxiety. The inventory evaluates how individuals feel at a particular moment. It includes 20 items, each scored from 1 (Not at all) to 4 (Completely), reflecting the intensity of the emotion experienced. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse scored. Total scores range from 20 to 80; higher scores indicate greater anxiety. Additionally, the "Trait Anxiety Inventory (STAI-II)" measures general anxiety independent of specific situations, using a similar 20-item structure with frequency-based responses. The full inventory contains 40 items. High scores on either scale indicate higher anxiety levels. This validated tool enables objective pre- and post-intervention comparison of anxiety states in clinical settings.
Measured: 12 month
The Effect of Mandala Painting on Stress
Perceived Stress Scale (PSS) This scale measures the extent to which a person subjectively perceives certain situations as stressful.The scale is a 5-point Likert format (0 = never; 4 = always) and consists of 4 questions for the positive dimension and 6 questions for the negative dimension. Scores obtained from the scale range from 0 to 40, with scores between 27 and 40 indicating perceived high levels of stress, scores between 14 and 26 indicating perceived moderate levels of stress, and scores between 0 and 13 indicating perceived low levels of stress.
Translated with DeepL.com (free version) The patient will answer PSS questions before and after the mandala coloring.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mandala PaintingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niran Çoban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niran Çoban, University of Yalova
- Investigators
- NİRAN ÇOBAN, Study director, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109492
- Sponsor's protocol ID
- NÇ.AT
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.
PubMed 22864564Mitchell M. General anaesthesia and day-case patient anxiety. J Adv Nurs. 2010 May;66(5):1059-71. doi: 10.1111/j.1365-2648.2010.05266.x. Epub 2010 Mar 9.
PubMed 20337788Curry, N. A., & Kasser, T. (2005). Can coloring mandalas reduce anxiety? Art Therapy, 22(2), 81-85. https://doi.org/10.1080/07421656.2005.10129441
Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Risk factors for postoperative anxiety in adults. Anaesthesia. 2001 Aug;56(8):720-8. doi: 10.1046/j.1365-2044.2001.01842.x.
PubMed 11493233Baran, T., & Demirtaş, A. (2022). Mandala boyama etkinliğinin stresle baş etme ve dikkat düzeyine etkisi. Psikoloji Çalışmaları Dergisi, 42(2), 77-91
Spielberger, C. D., Gorsuch, R. L., & Lushene, R. E. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mandala Painting Before Surgery on Anxiety and Stress
- ClinicalTrials.gov ID
- NCT07109492
- Acronym / sponsor ID
- NÇ.AT
- Conditions
- Mandala Painting, Surgery, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Niran ÇobanUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 7 Aug 2025 (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.
Surgical interventions often cause significant anxiety and stress in patients during the preoperative period. In this study, it is aimed to determine the effect of mandala coloring, a non-pharmacological and art-based intervention, on reducing anxiety and stress levels in individuals scheduled for elective surgery. The universe of the study will consist of patients who will undergo elective surgery between June 2025 and June 2026 in the General Surgery Clinic of Istanbul Sultangazi Training and Research Hospital. Data will be collected using the Introductory Information Form, State Anxiety Inventory (STAI-S), Perceived Stress Scale (PSS), and Physiological Parameters Form (including blood pressure, pulse, respiration rate, and oxygen saturation). One day before surgery, patients who meet the inclusion criteria will be informed about the study and randomized into intervention and control groups using a random number table created with MS Excel software. Patients in the intervention group will perform a 20-minute mandala coloring activity in the preoperative waiting period. Before and after the application, participants' anxiety and stress levels will be evaluated with the STAI-S and PSS, and their physiological parameters will be recorded. Patients in the control group will receive standard preoperative care and will be evaluated at the same time points with the same tools, without any intervention. The study aims to provide evidence for the use of mandala coloring as a simple, low-cost, and effective nursing intervention to reduce preoperative anxiety and stress.
Detailed description
Surgical procedures, although often lifesaving and necessary, are known to trigger significant levels of psychological distress, particularly in the preoperative period. This phase, characterized by uncertainty, fear of anesthesia, and concerns about postoperative outcomes, commonly leads to increased levels of anxiety and stress. Preoperative anxiety is reported in up to 85% of surgical patients and is associated with adverse outcomes such as elevated pain perception, delayed recovery, higher analgesic needs, increased cardiac complications, and lower patient satisfaction. While pharmacological approaches are commonly used, there is growing interest in non-pharmacological and holistic strategies to manage preoperative anxiety and stress effectively.
Among the emerging non-drug interventions, art-based therapeutic activities have gained attention due to their accessibility, affordability, and psychological benefits. One such method is mandala coloring, which involves filling in structured circular designs using colors of the participant's choice. The term "mandala" originates from Sanskrit, meaning "circle," and symbolizes wholeness and balance. According to Carl Jung, mandalas help individuals center themselves and connect with their inner states, offering a calming and integrative experience.
Mandala coloring has been shown to reduce stress and anxiety by directing attention to the present moment, promoting mindfulness, and eliciting meditative-like states. Unlike traditional art therapy, mandala coloring does not require artistic skill and can be easily implemented across various age and educational levels. Studies suggest that coloring mandalas decreases cortisol levels, improves emotional regulation, and enhances psychological well-being in different populations.
Despite its recognized benefits in mental health contexts, limited research exists on the use of mandala coloring specifically in surgical patients during the preoperative period. This study aims to fill this gap by evaluating the effect of a short, structured mandala coloring session on anxiety, stress, and selected physiological parameters among patients awaiting elective surgery.
The study will be conducted between June 2025 and June 2026 at Istanbul Sultangazi Training and Research Hospital's General Surgery Clinic. A total of 60 adult patients who meet the inclusion criteria will be recruited and randomly assigned to either the Mandala Coloring Group (intervention) or the Standard Care Group (control) using a random number table created in MS Excel.
On the day before surgery, participants will be informed about the study and will provide written informed consent. Baseline data will be collected using the Introductory Information Form, the State Anxiety Inventory (STAI-S), the Perceived Stress Scale (PSS), and a Physiological Parameters Form, which includes systolic and diastolic blood pressure, pulse rate, respiratory rate, and oxygen saturation.
Patients in the intervention group will engage in a 20-minute mandala coloring activity using standardized coloring sets in a quiet, preoperative room. Those in the control group will receive routine preoperative care in the same setting, without any additional intervention. Following the intervention period, all participants will undergo the same post-test measurements using the aforementioned tools.
By targeting both psychological and physiological indicators, this study aims to demonstrate that mandala coloring is a practical, low-cost, non-pharmacological approach that can be effectively integrated into routine preoperative nursing care. The findings are expected to contribute to evidence-based surgical nursing practices and support the inclusion of creative, holistic methods in the preparation of patients for surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandala painting | Experimental | Other: MandalaPre-surgery (Before Mandala Painting) Pre-surgery (After Mandala Painting - 20 minutes later) |
| Standard care | No intervention | –Since standard care will be applied to the patients in this group, in order to be parallel with the mandala group, the relevant scale questions will be answered by interviewing the patient 20 minutes before and after going to the operating room. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals who are undergoing elective surgery,
- Cholecystectomy Surgery is planned
Key exclusion criteria (6 listed)
- Individuals with a previous psychiatric diagnosis,
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 |
|---|---|---|
| MandalaMandala Painting | Other | Mandala painting |
Primary outcome
The Effect of Mandala Painting on Anxiety
Time frame: 12 month
State Anxiety Inventory: In this study, the "State Anxiety Inventory (STAI-I)" will be used before and after the mandala coloring to assess patients' situational anxiety. The inventory evaluates how individuals feel at a particular moment. It includes 20 items, each scored from 1 (Not at all) to 4 (Completely), reflecting the intensity of the emotion experienced. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse scored. Total scores range from 20 to 80; higher scores indicate greater anxiety. Additionally, the "Trait Anxiety Inventory (STAI-II)" measures general anxiety independent of specific situations, using a similar 20-item structure with frequency-based responses. The full inventory contains 40 items. High scores on either scale indicate higher anxiety levels. This validated tool enables objective pre- and post-intervention comparison of anxiety states in clinical settings.
The Effect of Mandala Painting on Stress
Time frame: 12 month
Perceived Stress Scale (PSS) This scale measures the extent to which a person subjectively perceives certain situations as stressful.The scale is a 5-point Likert format (0 = never; 4 = always) and consists of 4 questions for the positive dimension and 6 questions for the negative dimension. Scores obtained from the scale range from 0 to 40, with scores between 27 and 40 indicating perceived high levels of stress, scores between 14 and 26 indicating perceived moderate levels of stress, and scores between 0 and 13 indicating perceived low levels of stress. Translated with DeepL.com (free version) The patient will answer PSS questions before and after the mandala coloring.
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 26 Oct 2026.
- Background: PubMed 22864564Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.
- Background: PubMed 20337788Mitchell M. General anaesthesia and day-case patient anxiety. J Adv Nurs. 2010 May;66(5):1059-71. doi: 10.1111/j.1365-2648.2010.05266.x. Epub 2010 Mar 9.
- BackgroundCurry, N. A., & Kasser, T. (2005). Can coloring mandalas reduce anxiety? Art Therapy, 22(2), 81-85. https://doi.org/10.1080/07421656.2005.10129441
- Background: PubMed 11493233Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Risk factors for postoperative anxiety in adults. Anaesthesia. 2001 Aug;56(8):720-8. doi: 10.1046/j.1365-2044.2001.01842.x.
- BackgroundBaran, T., & Demirtaş, A. (2022). Mandala boyama etkinliğinin stresle baş etme ve dikkat düzeyine etkisi. Psikoloji Çalışmaları Dergisi, 42(2), 77-91
- BackgroundSpielberger, C. D., Gorsuch, R. L., & Lushene, R. E. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
- 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.
NİRAN ÇOBAN study director
University of Yalova
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 in people with Mandala Painting and Surgery, run by Niran Çoban 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 6 inclusion and 6 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 26 Oct 2026. 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?
The Effect of Mandala Painting on Anxiety (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07109492, which also lists 6 linked publications.
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 26 Oct 2026.