Missed AbortionNCT07420413
Effects of Mandala Coloring in Missed Abortion
A study testing Mandala Coloring Activity in people with Missed Abortion, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effects of mandala coloring activity on stress, anxiety, pain, and physiological parameters in women diagnosed with missed abortion. Participants will be randomly assigned to either a mandala coloring group or a control group receiving standard care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Mandala Coloring Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2025to 1 May 2026
- 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
- Women aged 18 years and older
- Hospitalized with a diagnosis of missed abortion
- Gestational age of 10 weeks or less
- Mentally healthy and able to communicate
- Able to read, understand, and speak Turkish
- Literate
Show all 11Show fewer
- Willing to participate and provide written informed consent
- ExcluPhysical limitations preventing participation in the coloring activity
- History of previous pregnancy loss
- Presence of chronic medical disease
- Diagnosis of a psychiatric disordersion Criteria:
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandala Coloring Activity on Stress, Anxiety, Pain and Physiological Parameters in Women Diagnosed With Missed Abortion: A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effects of mandala coloring activity on stress, anxiety, pain, and physiological parameters in women diagnosed with missed abortion. Participants will be randomly assigned to either a mandala coloring group or a control group receiving standard care. Outcomes will be measured at hospital admission and after completion of the mandala coloring session.
Read the detailed description
Missed abortion is a distressing pregnancy loss experience that may lead to increased anxiety, stress, and emotional burden in affected women. In addition to psychological distress, acute stress responses may also influence physiological parameters such as heart rate, blood pressure, oxygen saturation, and body temperature. Supportive, non-pharmacological interventions may help reduce emotional and physical discomfort during hospitalization.
Mandala coloring is a structured, repetitive art-based activity that may promote relaxation and emotional regulation. It is considered a simple, low-cost, and non-invasive supportive intervention that can be easily implemented in clinical settings.
This randomized controlled trial is designed to evaluate the effectiveness of mandala coloring activity in women diagnosed with missed abortion. Participants are randomly assigned to either a mandala coloring group receiving the intervention in addition to standard care, or a control group receiving standard care alone. The mandala session lasts a minimum of 30 minutes and is conducted during hospitalization.
Stress, state anxiety, and pain levels, along with physiological parameters (heart rate, blood pressure, oxygen saturation, and body temperature), are assessed at baseline (hospital admission) and immediately after completion of the intervention. The study aims to determine whether mandala coloring contributes to improved psychological well-being and physiological stability in women experiencing pregnancy loss.
- Conditions
- Missed Abortion
- Being tested
- Mandala Coloring Activity
- Keywords
- Missed Abortion, Mandala Coloring, Pregnancy Loss, Stress, Pain, Anxiety
- Medical subject headings
- Abortion, Missed, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Coloring ActivityBehavioural
Participants engage in a structured mandala coloring activity session during hospitalization in addition to standard care. The activity is conducted individually in a quiet environment.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Coloring Group | Experimental | Participants receive mandala coloring activity in addition to standard care during hospitalization. Receives: Behavioral: Mandala Coloring Activity |
| Control Group | No intervention | Participants receive standard care only during hospitalization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Score
State anxiety will be measured using the State Anxiety Inventory (STAI-State). The primary outcome is the change in anxiety score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization. Higher scores indicate greater anxiety.
Measured: At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
Change in Perceived Stress Score
Perceived stress will be measured using the Perceived Stress Scale (PSS). The secondary outcome is the change in stress score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization. Higher scores indicate greater perceived stress.
Measured: At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start30 Oct 2025
- Primary completion1 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants are randomized to either a mandala coloring activity group or a control group receiving standard care, and outcomes are assessed and compared between groups during hospitalization.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Arslantaş, Selcuk University
- Investigators
- Rukiye Arslantaş, MSc, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420413
- Sponsor's protocol ID
- SU-EC-2025/1049
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring Activity on Stress, Anxiety, Pain and Physiological Parameters in Women Diagnosed With Missed Abortion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07420413
- Acronym / sponsor ID
- SU-EC-2025/1049
- Conditions
- Missed Abortion
- Keywords
- Missed Abortion, Mandala Coloring, Pregnancy Loss, Stress, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 19 Feb 2026 (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.
This randomized controlled study aims to evaluate the effects of mandala coloring activity on stress, anxiety, pain, and physiological parameters in women diagnosed with missed abortion. Participants will be randomly assigned to either a mandala coloring group or a control group receiving standard care. Outcomes will be measured at hospital admission and after completion of the mandala coloring session.
Detailed description
Missed abortion is a distressing pregnancy loss experience that may lead to increased anxiety, stress, and emotional burden in affected women. In addition to psychological distress, acute stress responses may also influence physiological parameters such as heart rate, blood pressure, oxygen saturation, and body temperature. Supportive, non-pharmacological interventions may help reduce emotional and physical discomfort during hospitalization.
Mandala coloring is a structured, repetitive art-based activity that may promote relaxation and emotional regulation. It is considered a simple, low-cost, and non-invasive supportive intervention that can be easily implemented in clinical settings.
This randomized controlled trial is designed to evaluate the effectiveness of mandala coloring activity in women diagnosed with missed abortion. Participants are randomly assigned to either a mandala coloring group receiving the intervention in addition to standard care, or a control group receiving standard care alone. The mandala session lasts a minimum of 30 minutes and is conducted during hospitalization.
Stress, state anxiety, and pain levels, along with physiological parameters (heart rate, blood pressure, oxygen saturation, and body temperature), are assessed at baseline (hospital admission) and immediately after completion of the intervention. The study aims to determine whether mandala coloring contributes to improved psychological well-being and physiological stability in women experiencing pregnancy loss.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to either a mandala coloring activity group or a control group receiving standard care, and outcomes are assessed and compared between groups during hospitalization.
| Arm | Type | Receives |
|---|---|---|
| Mandala Coloring Group | Experimental | Behavioral: Mandala Coloring ActivityParticipants receive mandala coloring activity in addition to standard care during hospitalization. |
| Control Group | No intervention | –Participants receive standard care only during hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women aged 18 years and older
- Hospitalized with a diagnosis of missed abortion
- Gestational age of 10 weeks or less
- Mentally healthy and able to communicate
- Able to read, understand, and speak Turkish
Key exclusion criteria (0 listed)
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 Coloring ActivityParticipants engage in a structured mandala coloring activity session during hospitalization in addition to standard care. The activity is conducted individually in a quiet environment. | Behavioural | Mandala Coloring Group |
Primary outcome
Change in State Anxiety Score
Time frame: At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
State anxiety will be measured using the State Anxiety Inventory (STAI-State). The primary outcome is the change in anxiety score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization. Higher scores indicate greater anxiety.
Change in Perceived Stress Score
Time frame: At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization
Perceived stress will be measured using the Perceived Stress Scale (PSS). The secondary outcome is the change in stress score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization. Higher scores indicate greater perceived stress.
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 7 Aug 2026.
Related trials for Missed Abortion
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
RecruitingObservational study
Periodontal Pathogens and Inflammatory Biomarkers in Missed Abortion
Missed Abortion, Periodontitis
Not yet recruiting
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
Missed Abortion, Early Pregnancy Loss
Not yet recruiting
The Value of Pretreatment With Letrozole on Induction Time of Medical Evacuation With Misoprostol in Cases of Missed Abortion
Letrozole
Not yet recruitingPhase 1
Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy
Missed Abortion
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.
Rukiye Arslantaş, MSc principal investigator
Selcuk 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 Activity in people with Missed Abortion, run by Selcuk 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 11 inclusion and 0 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 7 Aug 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?
Change in State Anxiety Score (time frame: At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization). 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?
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 7 Aug 2026.