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NCT Number: NCT07764484

COLORING ACTIVITY APPLIED DURING LABOR IN PRIMIPAROUS PREGNANT WOMEN AND ITS EFFECT ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH.

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Mandala Coloring Activity During Labor

Behavioral

Participants will engage in a standardized mandala coloring activity during the active phase of labor in addition to routine labor and obstetric care. The activity will begin at 5-8 cm cervical dilation and will continue until birth as tolerated. Participants will use standardized A4-size mandala drawings and 24 colored pencils.

Primary outcomes

  1. Birth Anxiety

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Neslihan ATLI

CONTACT

[email protected]

+905456330214

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

THE EFFECT OF MANDALA COLORING ACTIVITY APPLIED DURING LABOR ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH IN PRIMIPAROUS PREGNANT WOMEN: A RANDOMIZED CONTROLLED TRIAL

Acronym: MANDALA-RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

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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