Pregnant WomenNCT06804018
Mandala Colouring: Its Impact on Well-Being, Self-Compassion, and Anxiety in Primiparous Pregnancies
A study testing Mandala coloring in people with Pregnant Women and Women Health, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Maintaining well-being during pregnancy, reducing anxiety and supporting self-compassion are critical for the health of expectant mothers and the development of the baby. In addition to traditional medicine, alternative therapeutic approaches have been increasingly popular in recent years as a supportive approach… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Women Health, Well Being
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2025to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35
- Being in the last three months of pregnancy (Amelia et al., 2020)
- Getting a State Anxiety Inventory (STAI) score of ≥40
- Having a smartphone and internet connection
- Being willing to participate in the study
- Being spontaneously pregnant
- Not having a diagnosed health risk (diabetes, preeclampsia, fetal anomaly, etc.) in the mother or fetus
Who cannot join
- Those who do not meet the Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Erbaa, Tokat Province, 60500
About this study
Official title: The Effect of Mandala Colouring Practice on Pregnancy Well-Being, Self-Compassion and Anxiety in Primiparous Pregnant Women: A Randomised Controlled Study
Maintaining well-being during pregnancy, reducing anxiety and supporting self-compassion are critical for the health of expectant mothers and the development of the baby. In addition to traditional medicine, alternative therapeutic approaches have been increasingly popular in recent years as a supportive approach during pregnancy. Among these alternative methods, creative activities such as mandala painting have the potential to reduce stress, increase mental focus and provide emotional balance.
H1: There is a difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
Read more
H0: There is no difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
Sub-Hypotheses of the Study:
H1-1: There is a difference in well-being between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
H1-2: There is a difference in self-compassion levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
H1-3: There is a difference in anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
Read the detailed description
Maintaining well-being, reducing anxiety, and supporting self-compassion during pregnancy are of critical importance for the health of expectant mothers and the development of the baby. In addition to traditional medicine, the use of alternative therapeutic approaches as a support during pregnancy has been increasingly gaining interest in recent years. Among these alternative methods, creative activities such as mandala painting have the potential to reduce stress, increase mental focus, and provide emotional balance (Babouchkina and Robbins, 2015; Stinley et al., 2015; Sandmire et al., 2016; Mo and Ko, 2023; Chen et al., 2024; Şolt Kırca and Dağlı, 2024). However, controlled studies evaluating the effects of mandala painting during pregnancy are limited (Şolt Kırca and Dağlı, 2024). In particular, it seems that the effects of mandala painting on psychological well-being, self-compassion, and anxiety levels in primiparous pregnant women and in the last trimester of pregnancy have not been systematically examined. With these effects, it is thought that mandala painting during pregnancy will be used as a stress management tool recommended by health professionals and will contribute to the field as it can contribute to the emotional well-being of future pregnant women.
Data Collection Tools In collecting the data of the research:
The research data will be collected using the Sociodemographic Characteristics Form, State Anxiety Scale, Pregnancy Well-Being Scale and Self-Compassion Scale Short Form. Sociodemographic Characteristics Form: The form consists of 6 questions in total and includes age, education level, employment status, perceived economic status, number of pregnancies and whether the pregnancy was planned. State Anxiety Scale: The State-Trait Anxiety Inventory (STAI) form developed by Spielberger (1983) is used for adults between the ages of 18-69 and consists of 20 items (state anxiety) measuring the intensity of anxiety as an emotional state (Spielberg, 1983). In order for pregnant women to express their own feelings, they can instantly mark how they feel without spending too much time on any expression, and it is evaluated as 1: not at all, 2: a little, 3: a lot and 4: completely. If no response is given to more than three statements, the completed form is considered invalid and is not scored. Direct statements express negative emotions; reversed statements express positive emotions. When scoring, those with a weight value of 1 are converted to 4, and those with a weight value of 4 are converted to 1. There are ten reverse-coded statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. Theoretically, the scores obtained vary between 20 and 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety (Spielberg, 1983). The scale was adapted to Turkish culture by Öner and Le Compte, and a reliability-validity study was conducted. In the Turkish version of the scale, reliability coefficients determined by Cronbach's alpha correlations were found to be between 0.83 and 0.92 (Öner and Le Compte, 1983). Well-Being Scale in Pregnancy: The Turkish validity-reliability study of the scale developed by Alderdice et al. (2015) in 2015 was conducted by Sunay et al. (2022). The Cronbach's alpha reliability coefficient in the original scale is 0.73 (Alderdice et al., 2015). The scale defines the characteristics of well-being measurement during pregnancy and general well-being gives women the opportunity to express their positive and negative feelings and thoughts about their pregnancy. The scale is a six-point Likert-type scale and the responses to the items are scored as "1 = always", "2 = most of the time", "3 = more than half of my time", "4 = less than half of my time", "5 = sometimes", "6 = never". The increase in the average score obtained from the scale indicates that well-being during pregnancy has increased. The scale consists of a total of 12 items and has two subscales: "Positive Affect and Satisfaction" and "Concerns". The Positive Affect and Satisfaction subscale (high scores indicate high positive emotions, positive relationships, and satisfaction with pregnancy and care) consists of 7 items (items 1, 2, 3, 5, 7, 11, and 12). The Concerns subscale (where high scores indicate less anxiety) consists of 5 items (items 4, 6, 8, 9, and 10). The 5 items of the Concerns subscale (items 4, 6, 8, 9, and 10) are calculated by reversing them. The Cronbach's alpha value of the scale was found to be 0.73. The Positive Affect and Satisfaction subscale of the scale was found to be 0.71, and the Concerns subscale was found to be 0.70 (Sunay et al., 2022). Self-Compassion Scale Short Form: The scale developed by Neff (2003) was converted into a short form by Raes, Pommier, Neff, and Van Gucht (2011). The form, whose Turkish validity and reliability study was conducted by Yıldırım and Sarı (2018), consists of a total of 11 questions. It is one-dimensional. The Likert-type scale is marked as 1: never, 2: rarely, 3: sometimes, 4: often, and 5: always. Items 1, 4, 8, 9, 10, and 11 of the scale are reverse-coded. The internal consistency coefficient of the scale was calculated as 0.75. The total scores obtained from the scale indicate that the self-compassion level of the individuals is high (Neff et al., 2003; Yıldırım and Sarı, 2018).
- Conditions
- Pregnant Women, Women Health, Well Being, Self Compassion, Anxiety
- Being tested
- Mandala coloring
- Keywords
- Pregnant women, anxiety, well being, self compassion, mandala coloring
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloringOther
Pregnant women who will paint mandalas
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (pregnant women who will paint mandalas) | Experimental | Each participant in the intervention group will be given 12 different colored felt-tip pens or 12 different colored crayons (whichever the pregnant woman wishes) and mandala pictures taken by the researcher.
They will be asked to choose the pictures they will color, and the pregnant women will be given mandalas with various patterns.
They will be asked to color for an average of 20-30 minutes two days a week (on the day and time period they want).
They will be told that they can do their coloring in an environment they want, that they will not have others do their coloring, and that they will not be called back to the hospital for coloring.
A reminder message* will be sent by the researcher according to the determined days before each coloring, and photos of the colored mandalas will be sent to the researcher via WhatsApp after coloring.
Afterwards, it will be explained that the STAI form, the Well-being in Pregnancy Scale, and the Self-Compassion Scale will need to be filled out a to Receives: Other: Mandala coloring |
| Control Group | No intervention | For the control group, the scales and forms will be filled out at the end of the second and fourth weeks. Pregnant women will be asked to fill out the forms at the end of the second and fourth weeks and send them to the researcher via WhatsApp, and they will not be invited to a face-to-face interview again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Scale
The State Anxiety Inventory (STAI-X) will be used to determine the anxiety status of pregnant women.
Measured: 5 weeks
Secondary outcomes (1)
Well-being
The Well-Being in Pregnancy Scale will evaluate pregnant women's cognitive evaluations of their own lives and the frequency and intensity of their positive and negative emotions.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start5 May 2025
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- 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
- Randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Abdurrahim UYANIK, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804018
- Sponsor's protocol ID
- Gaziosmanpasa-AU
- Status last verified
- Jun 2025
- First submitted
- 13 Jan 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Supporting information: CSR
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Colouring Practice on Pregnancy Well-Being, Self-Compassion and Anxiety in Primiparous Pregnant Women: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06804018
- Acronym / sponsor ID
- Gaziosmanpasa-AU
- Conditions
- Pregnant Women, Women Health, Well Being, Self Compassion, Anxiety
- Keywords
- Pregnant women, anxiety, well being, self compassion, mandala coloring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 5 May 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 31 Jan 2025 (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.
Maintaining well-being during pregnancy, reducing anxiety and supporting self-compassion are critical for the health of expectant mothers and the development of the baby. In addition to traditional medicine, alternative therapeutic approaches have been increasingly popular in recent years as a supportive approach during pregnancy. Among these alternative methods, creative activities such as mandala painting have the potential to reduce stress, increase mental focus and provide emotional balance.
H1: There is a difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
H0: There is no difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
Sub-Hypotheses of the Study:
H1-1: There is a difference in well-being between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
H1-2: There is a difference in self-compassion levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
H1-3: There is a difference in anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.
Detailed description
Maintaining well-being, reducing anxiety, and supporting self-compassion during pregnancy are of critical importance for the health of expectant mothers and the development of the baby. In addition to traditional medicine, the use of alternative therapeutic approaches as a support during pregnancy has been increasingly gaining interest in recent years. Among these alternative methods, creative activities such as mandala painting have the potential to reduce stress, increase mental focus, and provide emotional balance (Babouchkina and Robbins, 2015; Stinley et al., 2015; Sandmire et al., 2016; Mo and Ko, 2023; Chen et al., 2024; Şolt Kırca and Dağlı, 2024). However, controlled studies evaluating the effects of mandala painting during pregnancy are limited (Şolt Kırca and Dağlı, 2024). In particular, it seems that the effects of mandala painting on psychological well-being, self-compassion, and anxiety levels in primiparous pregnant women and in the last trimester of pregnancy have not been systematically examined. With these effects, it is thought that mandala painting during pregnancy will be used as a stress management tool recommended by health professionals and will contribute to the field as it can contribute to the emotional well-being of future pregnant women.
Data Collection Tools In collecting the data of the research:
The research data will be collected using the Sociodemographic Characteristics Form, State Anxiety Scale, Pregnancy Well-Being Scale and Self-Compassion Scale Short Form. Sociodemographic Characteristics Form: The form consists of 6 questions in total and includes age, education level, employment status, perceived economic status, number of pregnancies and whether the pregnancy was planned. State Anxiety Scale: The State-Trait Anxiety Inventory (STAI) form developed by Spielberger (1983) is used for adults between the ages of 18-69 and consists of 20 items (state anxiety) measuring the intensity of anxiety as an emotional state (Spielberg, 1983). In order for pregnant women to express their own feelings, they can instantly mark how they feel without spending too much time on any expression, and it is evaluated as 1: not at all, 2: a little, 3: a lot and 4: completely. If no response is given to more than three statements, the completed form is considered invalid and is not scored. Direct statements express negative emotions; reversed statements express positive emotions. When scoring, those with a weight value of 1 are converted to 4, and those with a weight value of 4 are converted to 1. There are ten reverse-coded statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. Theoretically, the scores obtained vary between 20 and 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety (Spielberg, 1983). The scale was adapted to Turkish culture by Öner and Le Compte, and a reliability-validity study was conducted. In the Turkish version of the scale, reliability coefficients determined by Cronbach's alpha correlations were found to be between 0.83 and 0.92 (Öner and Le Compte, 1983). Well-Being Scale in Pregnancy: The Turkish validity-reliability study of the scale developed by Alderdice et al. (2015) in 2015 was conducted by Sunay et al. (2022). The Cronbach's alpha reliability coefficient in the original scale is 0.73 (Alderdice et al., 2015). The scale defines the characteristics of well-being measurement during pregnancy and general well-being gives women the opportunity to express their positive and negative feelings and thoughts about their pregnancy. The scale is a six-point Likert-type scale and the responses to the items are scored as "1 = always", "2 = most of the time", "3 = more than half of my time", "4 = less than half of my time", "5 = sometimes", "6 = never". The increase in the average score obtained from the scale indicates that well-being during pregnancy has increased. The scale consists of a total of 12 items and has two subscales: "Positive Affect and Satisfaction" and "Concerns". The Positive Affect and Satisfaction subscale (high scores indicate high positive emotions, positive relationships, and satisfaction with pregnancy and care) consists of 7 items (items 1, 2, 3, 5, 7, 11, and 12). The Concerns subscale (where high scores indicate less anxiety) consists of 5 items (items 4, 6, 8, 9, and 10). The 5 items of the Concerns subscale (items 4, 6, 8, 9, and 10) are calculated by reversing them. The Cronbach's alpha value of the scale was found to be 0.73. The Positive Affect and Satisfaction subscale of the scale was found to be 0.71, and the Concerns subscale was found to be 0.70 (Sunay et al., 2022). Self-Compassion Scale Short Form: The scale developed by Neff (2003) was converted into a short form by Raes, Pommier, Neff, and Van Gucht (2011). The form, whose Turkish validity and reliability study was conducted by Yıldırım and Sarı (2018), consists of a total of 11 questions. It is one-dimensional. The Likert-type scale is marked as 1: never, 2: rarely, 3: sometimes, 4: often, and 5: always. Items 1, 4, 8, 9, 10, and 11 of the scale are reverse-coded. The internal consistency coefficient of the scale was calculated as 0.75. The total scores obtained from the scale indicate that the self-compassion level of the individuals is high (Neff et al., 2003; Yıldırım and Sarı, 2018).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (pregnant women who will paint mandalas) | Experimental | Other: Mandala coloringEach participant in the intervention group will be given 12 different colored felt-tip pens or 12 different colored crayons (whichever the pregnant woman wishes) and mandala pictures taken by the researcher. They will be asked to choose the pictures they will color, and the pregnant women will be given mandalas with various patterns. They will be asked to color for an average of 20-30 minutes two days a week (on the day and time period they want). They will be told that they can do their coloring in an environment they want, that they will not have others do their coloring, and that they will not be called back to the hospital for coloring. A reminder message* will be sent by the researcher according to the determined days before each coloring, and photos of the colored mandalas will be sent to the researcher via WhatsApp after coloring. Afterwards, it will be explained that the STAI form, the Well-being in Pregnancy Scale, and the Self-Compassion Scale will need to be filled out a to |
| Control Group | No intervention | –For the control group, the scales and forms will be filled out at the end of the second and fourth weeks. Pregnant women will be asked to fill out the forms at the end of the second and fourth weeks and send them to the researcher via WhatsApp, and they will not be invited to a face-to-face interview again. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being between the ages of 18-35
- Being in the last three months of pregnancy (Amelia et al., 2020)
- Getting a State Anxiety Inventory (STAI) score of ≥40
- Having a smartphone and internet connection
- Being willing to participate in the study
Key exclusion criteria (1 listed)
- Those who do not meet the Inclusion Criteria
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 coloringPregnant women who will paint mandalas | Other | Intervention Group (pregnant women who will paint mandalas) |
Primary outcome
Anxiety Scale
Time frame: 5 weeks
The State Anxiety Inventory (STAI-X) will be used to determine the anxiety status of pregnant women.
1 secondary outcome
Well-being
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes. Supporting information: CSR
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala coloring in people with Pregnant Women and Women Health, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Scale (time frame: 5 weeks). 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 12 Jun 2025.