NCT07420413

Brief 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. Outcomes will be measured at hospital admission and after completion of the mandala coloring session.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 12, 2026

Last Update Submit

February 20, 2026

Conditions

Missed Abortion

Keywords

Missed AbortionMandala ColoringPregnancy LossStressPainAnxiety

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization

Study Arms (2)

Mandala Coloring Group

EXPERIMENTAL

Participants receive mandala coloring activity in addition to standard care during hospitalization.

Behavioral: Mandala Coloring Activity

Control Group

NO INTERVENTION

Participants receive standard care only during hospitalization.

Interventions

Mandala Coloring ActivityBEHAVIORAL

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.

Mandala Coloring Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipation is restricted to biologically female individuals, as missed abortion is a pregnancy-related condition.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Selçuklu, 42250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Abortion, MissedPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Rukiye Arslantaş, MSc

    Selcuk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rukiye Arslantaş

CONTACT

+905379671005rukiyearslantas96@gmail.com

Bihter Akın, PhD

CONTACT

+05056703228bihterakin@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study due to the nature of the behavioral intervention.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

October 30, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

TU(1)