Post Partum DepressionNCT06637891
Mandala Coloring and Postpartum Blues
A study testing Mandala coloring in people with Post Partum Depression and Depression, Anxiety, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
One of the art therapy techniques that can provide psychological support and healing is mandala painting. Mandala is a Sanskrit word meaning 'circle'. The purpose of the circle is to encourage meditation, concentration and integration by narrowing or limiting the visual field towards the centre. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Depression, Depression, Anxiety
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 3 Mar 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35,
- Being between the 1st and 14th days postpartum
- Being able to read, understand and write Turkish,
- Having given birth at term (single birth at 38 weeks and above),
- Having given birth by normal vaginal delivery or cesarean section after an uncomplicated pregnancy
- Scoring 13 points or above on the Edinburgh Postpartum Depression Scale
- Scoring 3 points or above on the Stein Blues Scale
- Having stable vital signs, not having undergone infertility treatment, not having a chronic disease (such as hypertension, diabetes), not experiencing severe depression, anxiety and stress, not having any chronic disease or not having a disease that may cause cognitive impairment (such as delirium, dementia, mental retardation), not having serious complications in the mother and volunteering to participate in the study will be included in the study.
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandala Coloring on Postpartum Blues: a Randomized Controlled Trial
One of the art therapy techniques that can provide psychological support and healing is mandala painting. Mandala is a Sanskrit word meaning 'circle'. The purpose of the circle is to encourage meditation, concentration and integration by narrowing or limiting the visual field towards the centre. In mandala painting, the individual can focus on the lines, stay in the moment, separate themselves from the concerns of the past and future and allow them to recall the consciousness of the moment. Studies in the literature have reported that making mandalas is an effective method for reducing negative mood and anxiety in people.This study was planned as a randomized controlled study to help women who experience postpartum sadness get through this period more easily.
Read the detailed description
One of the art therapy techniques that can provide psychological support and healing is mandala painting. Mandala is a Sanskrit word meaning 'circle'. The purpose of the circle is to encourage meditation, concentration and integration by narrowing or limiting the visual field towards the center. In mandala painting, the individual can focus their attention on the lines, stay in the moment, separate themselves from the concerns of the past and future and ensure that they remember the consciousness of the moment again. The energy and emotions of the individual can change with the rich variety of colors used in mandala painting. It can help the individual achieve spiritual calmness by silencing the chaos and sounds that disturb them. Studies in the literature have reported that mandala painting is an effective method in reducing negative moods and anxiety in individuals. Gray-Foti found in his study that mandala painting reduced the anxiety levels of new mothers and increased their self-confidence, while Özsavran and Akyıldız found that it increased the comfort and resilience of mothers with special needs children. In a meta-analysis study evaluating the effect of mandala painting on state anxiety in adults, it was determined that it was effective in reducing anxiety. However, no study has been found investigating the effect of mandala coloring on postpartum sadness.This study was planned as a randomized controlled study to help women who experience postpartum sadness get through this period more easily.
- Conditions
- Post Partum Depression, Depression, Anxiety
- Being tested
- Mandala coloring
- Keywords
- Mandala coloring, postpartum blues
- Medical subject headings
- Depression, Postpartum, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloringOther
Participants will be asked to choose the pages they want from 12 colored felt-tip pen paint sets and 16 mandala coloring pages given to each participant by the researcher for 2 weeks, 3 days a week, at any time of the day and for an average of 20-30 minutes each time, and paint them in the colors they want.
| Study group | Role | What they receive |
|---|---|---|
| Mandala coloring group | Experimental | Mandala painting will be applied to postpartum women who have postpartum blues Receives: Other: Mandala coloring |
| Control group | No intervention | Participants in this group will consist of people who do not routinely do any practice on their own to reduce postpartum blues symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information form A form that includes questions about women's socio-demographic and pregnancy and characteristics. Introductory Information form
A form that includes questions about women's socio-demographic and pregnancy and characteristics. The survey consists of questions covering the personal characteristics, obstetric characteristics and psycho-social characteristics of new mothers.
Measured: between 1 to 4 weeks
Stein Blues Scale
The scale consists of two sections with a total of 13 questions. The first eight questions are Likert-type questions that examine mood symptoms. The second section investigates the presence of symptoms of headache, restlessness, difficulty in concentration, forgetfulness and confusion with five questions answered with yes/no. The scoring of the section with Likert-type questions varies between 0 and 4, and if there are symptoms in the last five questions, 1 point is added to the total score for each. The minimum score is 0, and the maximum score is 26. Patients are asked to answer the scale thinking only about that day.
Measured: between 1 to 4 weeks
Edinburgh Postpartum Depression Scale
Responses to the 4-point Likert-type scale consisting of ten questions are scored between 0 and 3. The cut-off score for the scale is taken as 12/13. If the score is 12 and below, the patient is not considered at risk for postpartum depression, and if it is 13 and above, the patient is considered at risk for postpartum depression. Scores from 0 to 30 are taken from the scale.
Measured: between 1 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Oct 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- ELIF DAGLI, P, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637891
- Sponsor's protocol ID
- KırklareliAS-14
- Status last verified
- Mar 2025
- First submitted
- 5 Oct 2024
- Last updated
- 17 Mar 2025
- 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Postpartum Blues: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06637891
- Acronym / sponsor ID
- KırklareliAS-14
- Conditions
- Post Partum Depression, Depression, Anxiety
- Keywords
- Mandala coloring, postpartum blues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 15 Oct 2024 (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.
One of the art therapy techniques that can provide psychological support and healing is mandala painting. Mandala is a Sanskrit word meaning 'circle'. The purpose of the circle is to encourage meditation, concentration and integration by narrowing or limiting the visual field towards the centre. In mandala painting, the individual can focus on the lines, stay in the moment, separate themselves from the concerns of the past and future and allow them to recall the consciousness of the moment. Studies in the literature have reported that making mandalas is an effective method for reducing negative mood and anxiety in people.This study was planned as a randomized controlled study to help women who experience postpartum sadness get through this period more easily.
Detailed description
One of the art therapy techniques that can provide psychological support and healing is mandala painting. Mandala is a Sanskrit word meaning 'circle'. The purpose of the circle is to encourage meditation, concentration and integration by narrowing or limiting the visual field towards the center. In mandala painting, the individual can focus their attention on the lines, stay in the moment, separate themselves from the concerns of the past and future and ensure that they remember the consciousness of the moment again. The energy and emotions of the individual can change with the rich variety of colors used in mandala painting. It can help the individual achieve spiritual calmness by silencing the chaos and sounds that disturb them. Studies in the literature have reported that mandala painting is an effective method in reducing negative moods and anxiety in individuals. Gray-Foti found in his study that mandala painting reduced the anxiety levels of new mothers and increased their self-confidence, while Özsavran and Akyıldız found that it increased the comfort and resilience of mothers with special needs children. In a meta-analysis study evaluating the effect of mandala painting on state anxiety in adults, it was determined that it was effective in reducing anxiety. However, no study has been found investigating the effect of mandala coloring on postpartum sadness.This study was planned as a randomized controlled study to help women who experience postpartum sadness get through this period more easily.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandala coloring group | Experimental | Other: Mandala coloringMandala painting will be applied to postpartum women who have postpartum blues |
| Control group | No intervention | –Participants in this group will consist of people who do not routinely do any practice on their own to reduce postpartum blues symptoms. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between the ages of 18-35,
- Being between the 1st and 14th days postpartum
- Being able to read, understand and write Turkish,
- Having given birth at term (single birth at 38 weeks and above),
- Having given birth by normal vaginal delivery or cesarean section after an uncomplicated pregnancy
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 coloringParticipants will be asked to choose the pages they want from 12 colored felt-tip pen paint sets and 16 mandala coloring pages given to each participant by the researcher for 2 weeks, 3 days a week, at any time of the day and for an average of 20-30 minutes each time, and paint them in the colors they want. | Other | Mandala coloring group |
Primary outcome
Introductory Information form A form that includes questions about women's socio-demographic and pregnancy and characteristics. Introductory Information form
Time frame: between 1 to 4 weeks
A form that includes questions about women's socio-demographic and pregnancy and characteristics. The survey consists of questions covering the personal characteristics, obstetric characteristics and psycho-social characteristics of new mothers.
Stein Blues Scale
Time frame: between 1 to 4 weeks
The scale consists of two sections with a total of 13 questions. The first eight questions are Likert-type questions that examine mood symptoms. The second section investigates the presence of symptoms of headache, restlessness, difficulty in concentration, forgetfulness and confusion with five questions answered with yes/no. The scoring of the section with Likert-type questions varies between 0 and 4, and if there are symptoms in the last five questions, 1 point is added to the total score for each. The minimum score is 0, and the maximum score is 26. Patients are asked to answer the scale thinking only about that day.
Edinburgh Postpartum Depression Scale
Time frame: between 1 to 4 weeks
Responses to the 4-point Likert-type scale consisting of ten questions are scored between 0 and 3. The cut-off score for the scale is taken as 12/13. If the score is 12 and below, the patient is not considered at risk for postpartum depression, and if it is 13 and above, the patient is considered at risk for postpartum depression. Scores from 0 to 30 are taken from the scale.
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 17 Mar 2025.
- 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.
ELIF DAGLI, P principal investigator
Cukurova University
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 coloring in people with Post Partum Depression and Depression, Anxiety, run by Kırklareli 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 8 inclusion and 1 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 17 Mar 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?
Introductory Information form A form that includes questions about women's socio-demographic and pregnancy and characteristics. Introductory Information form (time frame: between 1 to 4 weeks). 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 17 Mar 2025.