THE EFFECT OF MANDALA COLORING ACTIVITY APPLIED DURING LABOR ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH IN PRIMIPAROUS PREGNANT WOMEN: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Birth Anxiety
研究概览
简要总结
This randomized controlled trial aims to evaluate whether a mandala coloring activity during labor can reduce birth anxiety and fear of childbirth among primiparous pregnant women experiencing their first birth. The study will be conducted among eligible primiparous women admitted to the delivery unit at Şanlıurfa Training and Research Hospital during active labor.
A total of 140 primiparous pregnant women will be randomly assigned to either an intervention group or a control group. Women in the intervention group will receive standard labor care in addition to a structured mandala coloring activity beginning when cervical dilation is between 5 and 8 cm. Participants will be provided with standardized mandala drawings and coloring pencils and will be encouraged to color during contractions as tolerated until birth. Women in the control group will receive routine labor and obstetric care without an additional art-based or distraction intervention. Routine maternal and fetal monitoring will continue in both groups throughout labor.
Birth-related anxiety and fear will be assessed before the intervention during the active phase of labor and after birth. The study will use validated measures to evaluate fear of childbirth and birth-related anxiety. The study will also record relevant obstetric outcomes, including mode of delivery, analgesia use, and duration of labor.
The study seeks to answer whether adding a simple, low-cost, non-pharmacological mandala coloring activity to routine labor care can reduce birth anxiety and fear of childbirth in primiparous women. The findings may provide evidence for the use of accessible, non-pharmacological supportive interventions as part of midwifery care during labor.
详细描述
This study is designed to investigate the potential psychological benefits of a structured mandala coloring activity administered during the active phase of labor in primiparous women. Childbirth is a complex physiological and psychological process, and the transition to active labor may be accompanied by increased emotional distress, uncertainty, perceived loss of control, and fear related to pain and the anticipated birth experience. These psychological responses may influence how women perceive and cope with labor. Therefore, supportive interventions that can be incorporated into routine midwifery care without interfering with obstetric management may be clinically valuable.
Mandala coloring is considered a structured creative and attention-focused activity. The intervention is based on the premise that directing attention toward a repetitive and organized visual task may reduce excessive attention to labor-related discomfort and anxiety, facilitate relaxation, and support emotional regulation. Unlike unstructured drawing, the intervention in this study uses standardized mandala designs and the same type of coloring materials for all participants assigned to the intervention group. The activity is intended as a non-pharmacological supportive intervention rather than a psychotherapeutic treatment.
The study will be conducted in the delivery unit of Şanlıurfa Training and Research Hospital. Eligible participants will enter the study during active labor and will undergo the study procedures according to a predefined protocol. Following assessment and randomization, participants assigned to the intervention group will receive the mandala coloring activity in addition to routine obstetric and midwifery care. The activity will begin when cervical dilation is between 5 and 8 cm. Participants will be provided with standardized A4-size mandala designs and a standardized set of 24 colored pencils. They will be allowed to color according to their individual preference and comfort, primarily during the intervals between uterine contractions. The activity will continue during labor until birth, provided that the participant remains clinically appropriate and willing to participate.
The intervention will be delivered under standardized conditions. The same type and size of mandala material and coloring equipment will be used for participants. The intervention will be initiated by the researcher and conducted under midwifery supervision. The researcher will provide instructions regarding the activity but will not provide psychological interpretation, counseling, or therapeutic commentary during the coloring process. Participants will be allowed to perform the activity in a sitting or semi-sitting position according to their comfort. The intervention will not replace routine obstetric management, and maternal and fetal monitoring will continue according to standard clinical practice.
The control condition will consist of routine labor and obstetric care without an additional art-based or structured distraction intervention. Standard clinical management will remain available to participants in both study groups according to their clinical needs. The use of routine care as the comparator is intended to allow assessment of whether the addition of the mandala coloring activity provides a measurable benefit beyond usual care.
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
Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous pregnant women Age between 18-45 years Single pregnancy Full-term pregnancy (≥37 weeks) Planned vaginal delivery Ability to communicate and give informed voluntary consent Absence of diagnosed psychiatric disorder.
排除标准
- •High-risk pregnancy status (e.g., preeclampsia) Gestational diabetes requiring insulin Indication for emergency cesarean section Hearing or cognitive impairment Use of anxiolytic or psychiatric medications Refusal to participate in the study Intranatal complications preventing participation in mandala painting intervention
研究组 & 干预措施
Participant Group/Arm - Mandala
Participants will receive a standardized mandala coloring activity in addition to routine labor and obstetric care. The activity will begin during the active phase of labor at 5-8 cm cervical dilation. Participants will be provided with standardized A4-size mandala drawings and 24 colored pencils and will color during contractions as tolerated. The activity will continue until birth unless discontinued due to participant preference or clinical necessity. Routine maternal and fetal monitoring will continue throughout the intervention.
干预措施: Mandala Coloring Activity During Labor (Behavioral)
Control Group
Participants will receive routine labor and obstetric care without the mandala coloring activity. Routine maternal and fetal monitoring and other clinically indicated care will continue throughout labor.
结局指标
主要结局
Birth Anxiety
时间窗: During labor: baseline before the intervention and immediately after the intervention.
Change from baseline in maternal birth anxiety score measured using the Oxford Birth Anxiety Scale (OAS) during labor. Birth anxiety will be assessed immediately before the intervention (baseline) and immediately after the intervention. The outcome will be reported as the change in total OAS score from baseline to immediately after the intervention.
次要结局
未报告次要终点
研究者
Neslihan Atli
expert midwife
Ataturk University
