The Effect of Mandala Coloring Activity on Stress, Anxiety, Pain and Physiological Parameters in Women Diagnosed With Missed Abortion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change in State Anxiety Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study due to the nature of the behavioral intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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:
排除标准
- 未提供
研究组 & 干预措施
Mandala Coloring Group
Participants receive mandala coloring activity in addition to standard care during hospitalization.
干预措施: Mandala Coloring Activity (Behavioral)
Control Group
Participants receive standard care only during hospitalization.
结局指标
主要结局
Change in State Anxiety Score
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Rukiye Arslantaş
Principal Investigator
Selcuk University