COLORING ACTIVITY APPLIED DURING LABOR IN PRIMIPAROUS PREGNANT WOMEN AND ITS EFFECT ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH. (MANDALA-RCT)

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.

The timing of the intervention has been selected to correspond to the active phase of labor, when women may experience increasingly intense contractions while remaining capable of engaging with a structured activity, depending on their individual clinical condition. The intervention therefore focuses on the period in which attention diversion and relaxation may be particularly relevant to coping with labor-related discomfort and emotional distress.

The study uses a randomized controlled design to minimize systematic differences between the intervention and control groups. Participants who meet the study requirements and provide informed consent will be allocated to the study groups using a computer-based randomization procedure. Group allocation will be coded for the subsequent data management and statistical analysis. Because participants are aware of whether they receive the coloring activity, participant blinding is not feasible. The statistical analysis will be performed using coded group information to reduce potential analytical bias.

Data collection will follow a predefined sequence. Baseline assessments will be performed during the active phase of labor before the intervention. Following the intervention period and completion of childbirth, follow-up assessments will be performed after maternal stabilization during the early postpartum period. The study will therefore examine psychological outcomes in relation to the period immediately preceding the intervention and the period following childbirth.

Fear of childbirth will be evaluated using the validated Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire. Birth-related anxiety will be evaluated using the Oxford Childbirth Anxiety Questionnaire. The study protocol also permits the recording of relevant clinical and obstetric characteristics to provide contextual information regarding the childbirth process. These may include characteristics of labor and delivery that could influence the interpretation of psychological outcomes.

All procedures will be conducted in accordance with the principles of respect for autonomy, confidentiality, and voluntary participation. Participants will receive information about the study procedures before enrollment and will provide written informed consent. Participation will be voluntary, and participants may withdraw from the study at any time without affecting their routine clinical care.

The intervention is considered suitable for evaluation within midwifery care because it is simple to administer, requires limited materials, does not involve pharmacological agents, and can be performed alongside routine monitoring. The intervention is also designed to minimize disruption of the clinical management of labor. Maternal and fetal safety will remain the primary consideration throughout the intervention, and the activity will be discontinued whenever the participant does not wish to continue or when clinical circumstances require attention to obstetric care.

The study is intended to generate evidence regarding whether a structured, low-cost creative activity can provide additional psychological support during labor. In particular, the study will assess whether mandala coloring may represent a feasible complementary approach within midwifery care for addressing birth-related anxiety and fear among women experiencing childbirth for the first time. The findings may contribute to the development and evaluation of non-pharmacological supportive approaches that can be incorporated into woman-centered and evidence-based intrapartum care.