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Not yet recruitingNCT07764484MANDALA-RCTUpdated Nov 4, 2026

Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth

An interventional study of Mandala Coloring Activity During Labor in Fear of Childbirth and Mandala Coloring, sponsored by Ataturk University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

Updated Nov 4, 2026Start date movedEligibility revised+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Fear of Childbirth
  • Mandala Coloring

Keywords

  • CHILDBIRTH FEAR
  • BIRTH ANXIETY
  • MANDALA COLORING
  • PRIMIPAROUS WOMEN
  • MATERNAL MENTAL HEALTH
  • NON-PHARMACOLOGICAL INTERVENTION
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 4, 2026. See what changed

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

**Inclusion Criteria:**

  • Age over 18 years
  • Voluntary willingness to participate in the study
  • Gestational age between 38 and 40 weeks
  • Ability to speak Turkish
  • At least primary school education
  • Singleton pregnancy with a healthy fetus
  • Cervical dilation between 5 and 8 cm during labor

**Exclusion Criteria:**

  • Hearing, visual, or cognitive impairment that prevents effective communication
  • Diagnosed psychiatric disorder or receiving psychiatric treatment
  • Planned analgesia or anesthesia (e.g., epidural analgesia)
  • High-risk pregnancy (e.g., preeclampsia, eclampsia, gestational diabetes, or placenta previa)
  • Fetal anomaly
  • Multiple pregnancy
  • Inability to read and write or understand and complete the assessment scales
  • Physical inability to participate in the mandala coloring activity
  • Use of sedative or anxiolytic medication during the study period

**Withdrawal Criteria:**

  • Request to withdraw from the study
  • Incomplete assessment scales or failure to complete the data collection process
  • Decision for emergency cesarean section during labor
  • Operative vaginal delivery (vacuum or forceps)
  • Development of a maternal or neonatal intensive care requirement after birth
  • Development of fetal distress
  • Development of serious intrapartum obstetric complications (e.g., postpartum hemorrhage or uterine rupture)
  • Inability to obtain postpartum follow-up measurements
  • Stillbirth
  • Delivery of a high-risk newborn
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Mandala Coloring Activity During Labor

  • No intervention
    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.

Interventions

  • BehavioralMandala Coloring Activity During Labor

    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.

06

What researchers measure

Primary outcomes

  1. Birth Anxiety

    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.

    Time frame: During labor: baseline before the intervention and immediately after the intervention.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality concerns. The data include sensitive clinical information collected from pregnant women during labor, and sharing is restricted in accordance with institutional ethics committee regulations and participant consent.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Nov 2026, 0 months later.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2026
First posted
Aug 14, 2026
StartEst.
Nov 3, 2026was Sep 2026
Primary completionEst.
Nov 30, 2026
CompletionEst.
Jan 30, 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 1, 2026→Nov 3, 2026
Nov 4, 2026
Eligibility
Criteria largely rewritten (31 changes)
What changed in the criteria
  • Added**Inclusion Criteria:**
  • AddedAge over 18 years
  • AddedVoluntary willingness to participate in the study
  • AddedGestational age between 38 and 40 weeks
  • AddedAbility to speak Turkish
  • AddedAt least primary school education
  • AddedSingleton pregnancy with a healthy fetus
  • AddedCervical dilation between 5 and 8 cm during labor
  • Added**Exclusion Criteria:**
  • AddedHearing, visual, or cognitive impairment that prevents effective communication
  • AddedDiagnosed psychiatric disorder or receiving psychiatric treatment
  • AddedPlanned analgesia or anesthesia (e.g., epidural analgesia)
  • AddedHigh-risk pregnancy (e.g., preeclampsia, eclampsia, gestational diabetes, or placenta previa)
  • AddedFetal anomaly
  • AddedMultiple pregnancy
  • AddedInability to read and write or understand and complete the assessment scales
  • AddedPhysical inability to participate in the mandala coloring activity
  • AddedUse of sedative or anxiolytic medication during the study period
  • Added**Withdrawal Criteria:**
  • AddedRequest to withdraw from the study
  • AddedIncomplete assessment scales or failure to complete the data collection process
  • AddedDecision for emergency cesarean section during labor
  • AddedOperative vaginal delivery (vacuum or forceps)
  • AddedDevelopment of a maternal or neonatal intensive care requirement after birth
  • AddedDevelopment of fetal distress
  • AddedDevelopment of serious intrapartum obstetric complications (e.g., postpartum hemorrhage or uterine rupture)
  • AddedInability to obtain postpartum follow-up measurements
  • AddedStillbirth
  • AddedDelivery of a high-risk newborn
Inclusion criteria
  • RemovedPrimiparous 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
  • RemovedHigh-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
Nov 4, 2026
Title
COLORING ACTIVITY APPLIED DURING LABOR IN PRIMIPAROUS PREGNANT WOMEN AND ITS EFFECT ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH.Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Start date Sep 1, 2026→Nov 3, 2026
    Eligibility Criteria largely rewritten (31 changes)
    What changed in the criteria
    • Added**Inclusion Criteria:**
    • AddedAge over 18 years
    • AddedVoluntary willingness to participate in the study
    • AddedGestational age between 38 and 40 weeks
    • AddedAbility to speak Turkish
    • AddedAt least primary school education
    • AddedSingleton pregnancy with a healthy fetus
    • AddedCervical dilation between 5 and 8 cm during labor
    • Added**Exclusion Criteria:**
    • AddedHearing, visual, or cognitive impairment that prevents effective communication
    • AddedDiagnosed psychiatric disorder or receiving psychiatric treatment
    • AddedPlanned analgesia or anesthesia (e.g., epidural analgesia)
    • AddedHigh-risk pregnancy (e.g., preeclampsia, eclampsia, gestational diabetes, or placenta previa)
    • AddedFetal anomaly
    • AddedMultiple pregnancy
    • AddedInability to read and write or understand and complete the assessment scales
    • AddedPhysical inability to participate in the mandala coloring activity
    • AddedUse of sedative or anxiolytic medication during the study period
    • Added**Withdrawal Criteria:**
    • AddedRequest to withdraw from the study
    • AddedIncomplete assessment scales or failure to complete the data collection process
    • AddedDecision for emergency cesarean section during labor
    • AddedOperative vaginal delivery (vacuum or forceps)
    • AddedDevelopment of a maternal or neonatal intensive care requirement after birth
    • AddedDevelopment of fetal distress
    • AddedDevelopment of serious intrapartum obstetric complications (e.g., postpartum hemorrhage or uterine rupture)
    • AddedInability to obtain postpartum follow-up measurements
    • AddedStillbirth
    • AddedDelivery of a high-risk newborn
    Inclusion criteria
    • RemovedPrimiparous 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
    • RemovedHigh-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
    Title COLORING ACTIVITY APPLIED DURING LABOR IN PRIMIPAROUS PREGNANT WOMEN AND ITS EFFECT ON BIRTH ANXIETY AND FEAR OF CHILDBIRTH.Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
    + 2 other changes: verification date and responsible party

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07764484
Lead sponsor
Ataturk University
Responsible party
Neslihan Atli (Principal Investigator, Ataturk University) — Principal investigator
First posted
Aug 14, 2026
Start date
Nov 3, 2026 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Neslihan ATLI
Contact
neslihanatli96@gmail.com
+905456330214

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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