Konya City Hospital
Konya, Selçuklu, 42250, Turkey (Türkiye)
Location status: Recruiting
Location contact
Bihter Akın, PhD
CONTACT
Rukiye Arslantaş, MSc
PRINCIPAL_INVESTIGATOR
Rukiye Arslantaş, Msc
CONTACT
NCT Number: NCT07420413
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Konya, Selçuklu, 42250, Turkey (Türkiye)
Location status: Recruiting
Bihter Akın, PhD
CONTACT
Rukiye Arslantaş, MSc
PRINCIPAL_INVESTIGATOR
Rukiye Arslantaş, Msc
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Selcuk University
Other
The Effect of Mandala Coloring Activity on Stress, Anxiety, Pain and Physiological Parameters in Women Diagnosed With Missed Abortion: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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