Mandala PaintingNCT07160062
Mandala Painting on Perioperative Psychological Well-Being,Emotional Self-Efficacy,Anxiety
A study testing Mandala painting in people with Mandala Painting and Gynecological Cancers, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to investigate the effect of mandala painting on psychological well-being, emotional self-efficacy, and anxiety in gynecological cancer patients during the perioperative period. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mandala Painting, Gynecological Cancers, Psychological Well-being
- What is being tested?
- Mandala painting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2025to 26 Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Diagnosed with any type or stage of gynecological cancer,
- In the perioperative period and scheduled for surgery,
- Willing to participate in this intervention,
- With written consent,
- Volunteering to participate in the study
Who cannot join
- Those with a serious physical or mental illness,
- Those with intellectual or cognitive impairment,
- Those with serious perioperative medical complications,
- Those who withdrew or dropped out of the study early,
- Those who were not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandala Painting on Perioperative Psychological Well-Being, Emotional Self-Efficacy and Anxiety in Gynecologic Cancer Patients: A Randomized Controlled Study
Aim: The aim of this study was to investigate the effect of mandala painting on psychological well-being, emotional self-efficacy, and anxiety in gynecological cancer patients during the perioperative period.
- Being tested
- Mandala painting
- Keywords
- Emotional Self-Efficacy
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala paintingBehavioural
Each mandala painting process took a total of 35 to 50 minutes, consisting of 30 to 40 minutes for mandala painting and drawing and 5 to 10 minutes for explaining the painted mandala.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Mandala painting |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Self-Efficacy Scale
The Turkish adaptation of the scale developed by Kirk, Shutte, and Hine was conducted by Totan, İkiz, and Karaca. The scale consists of 32 items and is based on a 5-point Likert scale (1-Strongly disagree, 7-Strongly agree).
Measured: change from before implamentation patent and after 1st and 3rd days of practice
Psychological Well-Being Scale
The scale was developed by Diener et al. to integrate and complement psychological well-being data and to measure social and psychological well-being. The Psychological Well-Being Scale was adapted into Turkish by Telef. The Cronbach's Alpha internal consistency coefficient obtained in the reliability study of the scale was calculated as .80. The Psychological Well-Being Scale consists of 8 items.
Measured: change from before implamentation patent and after 1st, and 3rd day of practice
State Anxiety Scale
The State and Trait Anxiety Scale, developed by Spielberger et al., was adapted into Turkish by Öner and Le Compte. It consists of two sections, each containing 20 questions. The questions in the State Anxiety Scale (SAS), which measures short-term anxiety arising from a temporary dangerous situation, are on a 4-point Likert scale (1: Not at all, 2: A little, 3: Very much, 4: Completely).
Measured: change from before implamentation patent and after 1st and 3rd days of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start20 May 2025
- Primary completion25 May 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160062
- Sponsor's protocol ID
- 2025-SBB-0325
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Painting on Perioperative Psychological Well-Being, Emotional Self-Efficacy and Anxiety in Gynecologic Cancer Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07160062
- Acronym / sponsor ID
- 2025-SBB-0325
- Keywords
- Emotional Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 20 May 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 8 Sep 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.
Aim: The aim of this study was to investigate the effect of mandala painting on psychological well-being, emotional self-efficacy, and anxiety in gynecological cancer patients during the perioperative period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mandala painting |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older,
- Diagnosed with any type or stage of gynecological cancer,
- In the perioperative period and scheduled for surgery,
- Willing to participate in this intervention,
- With written consent,
Key exclusion criteria (5 listed)
- Those with a serious physical or mental illness,
- Those with intellectual or cognitive impairment,
- Those with serious perioperative medical complications,
- Those who withdrew or dropped out of the study early,
- Those who were not willing to participate in the study.
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 paintingEach mandala painting process took a total of 35 to 50 minutes, consisting of 30 to 40 minutes for mandala painting and drawing and 5 to 10 minutes for explaining the painted mandala. | Behavioural | Intervention group |
Primary outcome
Emotional Self-Efficacy Scale
Time frame: change from before implamentation patent and after 1st and 3rd days of practice
The Turkish adaptation of the scale developed by Kirk, Shutte, and Hine was conducted by Totan, İkiz, and Karaca. The scale consists of 32 items and is based on a 5-point Likert scale (1-Strongly disagree, 7-Strongly agree).
Psychological Well-Being Scale
Time frame: change from before implamentation patent and after 1st, and 3rd day of practice
The scale was developed by Diener et al. to integrate and complement psychological well-being data and to measure social and psychological well-being. The Psychological Well-Being Scale was adapted into Turkish by Telef. The Cronbach's Alpha internal consistency coefficient obtained in the reliability study of the scale was calculated as .80. The Psychological Well-Being Scale consists of 8 items.
State Anxiety Scale
Time frame: change from before implamentation patent and after 1st and 3rd days of practice
The State and Trait Anxiety Scale, developed by Spielberger et al., was adapted into Turkish by Öner and Le Compte. It consists of two sections, each containing 20 questions. The questions in the State Anxiety Scale (SAS), which measures short-term anxiety arising from a temporary dangerous situation, are on a 4-point Likert scale (1: Not at all, 2: A little, 3: Very much, 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 12 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 painting in people with Mandala Painting and Gynecological Cancers, run by Trakya 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 6 inclusion and 5 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 12 Sep 2025. 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?
Emotional Self-Efficacy Scale (time frame: change from before implamentation patent and after 1st and 3rd days of practice). The study lists 3 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 12 Sep 2025.