Perinatal LossNCT07060768
The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss
A study testing Mandala Coloring in people with Perinatal Loss, run by University of Yalova.
Trial summary
The goal of this clinical trial is to evaluate if mandala colouring helps to decrease grief symptoms and increase resilience in women who experienced perinatal loss. The main questions are: Does mandala coloring decrease perinatal grief symptoms? Does mandala coloring increase resilience? Researchers will compare… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Loss
- What is being tested?
- Mandala Coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Experienced perinatal loss (neonatal death, fetal death, abortion) within the last six weeks
Who cannot join
- Serious psychological problem that requires intervention with the recommendation of a psychiatrist, such as having a previous mental disorder or use of antidepressants.
- Practicing alternative methods such as yoga, meditation, acupuncture
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate if mandala colouring helps to decrease grief symptoms and increase resilience in women who experienced perinatal loss.
The main questions are:
Does mandala coloring decrease perinatal grief symptoms? Does mandala coloring increase resilience?
Researchers will compare mandala coloring intervention with standard perinatal loss nursing care to evaluate if mandala coloring works to decrease grief symptoms.
Participants will:
Answer some questionnaires and scales, and do mandala coloring at least for 20 minutes for 10 days after perinatal loss experience.
- Conditions
- Perinatal Loss
- Being tested
- Mandala Coloring
- Keywords
- perinatal loss, resilience, perinatal grief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ColoringOther
Mandala coloring at least 20 minutes each day. Totally 10 days intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will have mandala coloring intervention Receives: Other: Mandala Coloring |
| Control | No intervention | This arm will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal Grief
Perinatal Grief will be assessed via Perinatal Grief Scale. The scale is a 5-point Likert-type scale and responses range from "strongly agree to strongly disagree". The scale includes three sub-dimensions: "active grief", "difficulty coping" and "hopelessness". The total number of items in the scale is 32. Items 11 and 32 of the scale have a positive sentence structure. These items are answered in reverse. While the total grief score that can be obtained from the scale varies between 32-160, the scores that can be obtained for each sub-dimension seperately.
As the total perinatal grief score and the total score obtained from the sub-dimensions increase, it is determined that the individual's grief level is higher.
Measured: 1st day to 10th day
Perinatal Grief Intensity
Will be assessed via Perinatal Grief Intensity Scale. The scale consists of 14 items, rated on a 4-point Likert-type scale from strongly agree to strongly disagree, and three sub-dimensions: "reality", "confrontation with others", and "adaptation". The scale contains both positive and negative expressions. Therefore, items 1, 2, 3, and 6 are evaluated as reverse items in the scoring of the scale. When calculating the scores of the sub-dimensions, the score obtained from each item is added up and divided by the number of items in the sub-dimension. Thus, a total score between 1 and 4 is obtained from each sub-dimension. The following formula is used for the total score:
3.08 + (0.41 x reality sub-dimension mean score) - (0.2 x confrontation sub-dimension mean score) - (0.15 x harmony sub-dimension mean score) The score that can be obtained from the scale varies between 2.09 - 4.37. It is predicted that the intensity of grief that will be experienced increases as the score increases
Measured: 1st day to 10th day
Secondary outcomes (1)
Resilience
Will be assessed via Resilience Scale for Adults. The scale has a schematic evaluation with five boxes. The scale consists of six factors titled 'Self-perception, 'Future perception,' 'Structural style,' 'Social competence,' 'Family harmony,' and 'Social resources,' and contains a total of 33 items. Cronbach's alpha coefficient of the sub-dimensions of the scale varies between 0.75-0.86
Measured: 1st day and 10th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perinatal LossStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Balkan, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060768
- Sponsor's protocol ID
- EBYalova
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared publicly due to ethical restrictions. But authors may share IPD with researchers who reach out to the authors for data sharing with necessary reasons
Publications
Hutti MH, dePacheco M, Smith M. A study of miscarriage: development and validation of the Perinatal Grief Intensity Scale. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):547-55. doi: 10.1111/j.1552-6909.1998.tb02621.x.
PubMed 9773366Kones MO, Kaydırak MM, Aslan E, Yildiz H. The Perinatal Grief Scale (33-item short version): validity and reliability of the Turkish version. Anadolu Psikiyatri Derg. 2017; 18(3): 231-236. doi:10.5455/apd.234509.
Toedter LJ, Lasker JN, Alhadeff JM. The Perinatal Grief Scale: development and initial validation. Am J Orthopsychiatry. 1988 Jul;58(3):435-49. doi: 10.1111/j.1939-0025.1988.tb01604.x.
PubMed 3407734
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07060768
- Acronym / sponsor ID
- EBYalova
- Conditions
- Perinatal Loss
- Keywords
- perinatal loss, resilience, perinatal grief
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Jul 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.
The goal of this clinical trial is to evaluate if mandala colouring helps to decrease grief symptoms and increase resilience in women who experienced perinatal loss.
The main questions are:
Does mandala coloring decrease perinatal grief symptoms? Does mandala coloring increase resilience?
Researchers will compare mandala coloring intervention with standard perinatal loss nursing care to evaluate if mandala coloring works to decrease grief symptoms.
Participants will:
Answer some questionnaires and scales, and do mandala coloring at least for 20 minutes for 10 days after perinatal loss experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Mandala ColoringThis arm will have mandala coloring intervention |
| Control | No intervention | –This arm will not receive any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Experienced perinatal loss (neonatal death, fetal death, abortion) within the last six weeks
Key exclusion criteria (2 listed)
- Serious psychological problem that requires intervention with the recommendation of a psychiatrist, such as having a previous mental disorder or use of antidepressants.
- Practicing alternative methods such as yoga, meditation, acupuncture
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 ColoringMandala coloring at least 20 minutes each day. Totally 10 days intervention | Other | Intervention |
Primary outcome
Perinatal Grief
Time frame: 1st day to 10th day
Perinatal Grief will be assessed via Perinatal Grief Scale. The scale is a 5-point Likert-type scale and responses range from "strongly agree to strongly disagree". The scale includes three sub-dimensions: "active grief", "difficulty coping" and "hopelessness". The total number of items in the scale is 32. Items 11 and 32 of the scale have a positive sentence structure. These items are answered in reverse. While the total grief score that can be obtained from the scale varies between 32-160, the scores that can be obtained for each sub-dimension seperately. As the total perinatal grief score and the total score obtained from the sub-dimensions increase, it is determined that the individual's grief level is higher.
Perinatal Grief Intensity
Time frame: 1st day to 10th day
Will be assessed via Perinatal Grief Intensity Scale. The scale consists of 14 items, rated on a 4-point Likert-type scale from strongly agree to strongly disagree, and three sub-dimensions: "reality", "confrontation with others", and "adaptation". The scale contains both positive and negative expressions. Therefore, items 1, 2, 3, and 6 are evaluated as reverse items in the scoring of the scale. When calculating the scores of the sub-dimensions, the score obtained from each item is added up and divided by the number of items in the sub-dimension. Thus, a total score between 1 and 4 is obtained from each sub-dimension. The following formula is used for the total score: 3.08 + (0.41 x reality sub-dimension mean score) - (0.2 x confrontation sub-dimension mean score) - (0.15 x harmony sub-dimension mean score) The score that can be obtained from the scale varies between 2.09 - 4.37. It is predicted that the intensity of grief that will be experienced increases as the score increases
1 secondary outcome
Resilience
Time frame: 1st day and 10th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 9773366Hutti MH, dePacheco M, Smith M. A study of miscarriage: development and validation of the Perinatal Grief Intensity Scale. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):547-55. doi: 10.1111/j.1552-6909.1998.tb02621.x.
- BackgroundKones MO, Kaydırak MM, Aslan E, Yildiz H. The Perinatal Grief Scale (33-item short version): validity and reliability of the Turkish version. Anadolu Psikiyatri Derg. 2017; 18(3): 231-236. doi:10.5455/apd.234509.
- Background: PubMed 3407734Toedter LJ, Lasker JN, Alhadeff JM. The Perinatal Grief Scale: development and initial validation. Am J Orthopsychiatry. 1988 Jul;58(3):435-49. doi: 10.1111/j.1939-0025.1988.tb01604.x.
- Individual participant dataSharing planned: No. IPD will not be shared publicly due to ethical restrictions. But authors may share IPD with researchers who reach out to the authors for data sharing with necessary reasons
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Coloring in people with Perinatal Loss, run by University of Yalova.
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 1 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: opening soon, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Balkan, PhD Student (+905423513125, elif.balkan@yalova.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Grief (time frame: 1st day to 10th day). 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 NCT07060768, which also lists 3 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 15 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.