Mental Health IssuemandalaNCT05444010
Mandala Intervention on Mental Distress in Nurses Working With Terminally Ill Patients
A study testing mandala painting in people with Mental Health Issue, run by Istanbul Sabahattin Zaim University at 2 sites in Turkey (Türkiye).
Trial summary
Mandala application intervention of mental distress in nurses working with terminally ill patients Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- 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
- 56 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2022to 20 Jun 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteer
- active employee
- year of study
Who cannot join
- paint allergy
- use of psychiatric drugs Loss of loved one in the last six months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
SZU
Istanbul, İSTANBUL/halkalı, 34000
SZU
Istanbul, İ̇stanbul, 34000
About this study
Official title: Mandala Intervention on Mental Health Problems of Nurses Caring for Terminally Ill Patients
Mandala application intervention of mental distress in nurses working with terminally ill patients
Read the detailed description
Questionnaires were applied to the control and experimental groups. Mandala painting was done to the experimental group. Questionnaires were applied to the control and experimental groups again. Distress, anxiety, depression, death anxiety, death depression and psychological well-being of the experimental and control groups were evaluated.
- Conditions
- Mental Health Issue
- Being tested
- mandala painting
- Keywords
- mental health, anxiety, depression
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandala paintingBehavioural
nurse painted mandala for relaksing
| Study group | Role | What they receive |
|---|---|---|
| mental health | Experimental | The effect of mandala painting on mental health. Mental health-related anxiety, depression, well-being, distress and death anxiety and depression will be measured. Receives: Behavioral: mandala painting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck depresion scale
depresion is mental breakdown, depresion for beck depresion scale, 0-9 depresion emity, 10-15 light depression, 16-23 middle depresion, 24- 63 severe depression
Measured: 4 week
Secondary outcomes (1)
STAI-trait anxiety scale
anxiete is boredom, anxiete for trait anxiety scale, 0-15 anxiety none,n , 15-30 light anxiety, 30-60 middle anxiety, over 60 severe anxiety
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start15 May 2022
- Primary completion15 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is an experimental study with pre-test and post-test control grups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Nurdaş, Istanbul Sabahattin Zaim University
- Investigators
- RUKİYE PINAR BÖLÜKTAŞ, Study director, SZU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444010
- Sponsor's protocol ID
- ISZU
- Acronym
- mandala
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: mandala painting 4 week
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandala Intervention on Mental Health Problems of Nurses Caring for Terminally Ill Patients
- ClinicalTrials.gov ID
- NCT05444010
- Acronym / sponsor ID
- mandala / ISZU
- Conditions
- Mental Health Issue
- Keywords
- mental health, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 5 Jul 2022 (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.
Mandala application intervention of mental distress in nurses working with terminally ill patients
Detailed description
Questionnaires were applied to the control and experimental groups. Mandala painting was done to the experimental group. Questionnaires were applied to the control and experimental groups again. Distress, anxiety, depression, death anxiety, death depression and psychological well-being of the experimental and control groups were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an experimental study with pre-test and post-test control grups
| Arm | Type | Receives |
|---|---|---|
| mental health | Experimental | Behavioral: mandala paintingThe effect of mandala painting on mental health. Mental health-related anxiety, depression, well-being, distress and death anxiety and depression will be measured. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- volunteer
- active employee
- year of study
Key exclusion criteria (2 listed)
- paint allergy
- use of psychiatric drugs Loss of loved one in the last six months
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 paintingnurse painted mandala for relaksing | Behavioural | mental health |
Primary outcome
Beck depresion scale
Time frame: 4 week
depresion is mental breakdown, depresion for beck depresion scale, 0-9 depresion emity, 10-15 light depression, 16-23 middle depresion, 24- 63 severe depression
1 secondary outcome
STAI-trait anxiety scale
Time frame: 4 week
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 28 Jul 2022.
- Individual participant dataSharing planned: Yes. mandala painting 4 week
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Mental Health Issue
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.
RUKİYE PINAR BÖLÜKTAŞ study director
SZU
2 sites 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 Mental Health Issue, run by Istanbul Sabahattin Zaim University at 2 sites 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 3 inclusion and 2 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Beck depresion scale (time frame: 4 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 28 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.