Fear of ChildbirthMANDALA-RCTNCT07764484
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
A study testing Mandala Coloring Activity During Labor in people with Fear of Childbirth and Mandala Coloring, run by Ataturk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fear of Childbirth, Mandala Coloring
- What is being tested?
- Mandala Coloring Activity During Labor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Fear of Childbirth, Mandala Coloring
- Being tested
- Mandala Coloring Activity During Labor
- Keywords
- CHILDBIRTH FEAR, BIRTH ANXIETY, MANDALA COLORING, PRIMIPAROUS WOMEN, MATERNAL MENTAL HEALTH, NON-PHARMACOLOGICAL INTERVENTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Coloring Activity During LaborBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm - Mandala | Experimental | 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. Receives: Behavioral: Mandala Coloring Activity During Labor |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During labor: baseline before the intervention and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start3 Nov 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial. Participants will be allocated to either the intervention group or the control group. The intervention group will receive mandala coloring activity during labor, while the control group will receive standard routine care. Outcomes will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Atli, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764484
- Sponsor's protocol ID
- MANDALA-RCT-2026
- Acronym
- MANDALA-RCT
- Status last verified
- Nov 2026
- First submitted
- 25 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
- ClinicalTrials.gov ID
- NCT07764484
- Acronym / sponsor ID
- MANDALA-RCT / MANDALA-RCT-2026
- Conditions
- Fear of Childbirth, Mandala Coloring
- Keywords
- CHILDBIRTH FEAR, BIRTH ANXIETY, MANDALA COLORING, PRIMIPAROUS WOMEN, MATERNAL MENTAL HEALTH, NON-PHARMACOLOGICAL INTERVENTION
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial. Participants will be allocated to either the intervention group or the control group. The intervention group will receive mandala coloring activity during labor, while the control group will receive standard routine care. Outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm - Mandala | Experimental | Behavioral: Mandala Coloring Activity During LaborParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala Coloring Activity During LaborParticipants 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. | Behavioural | Participant Group/Arm - Mandala |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Coloring Activity During Labor in people with Fear of Childbirth and Mandala Coloring, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neslihan ATLI (+905456330214, neslihanatli96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth Anxiety (time frame: During labor: baseline before the intervention and immediately after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.