AnxietyNCT05534867
Effects of Mandala Coloring on Anxiety in Pregnant Women
A study testing Mandala coloring in people with Anxiety and Pregnancy Related, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt by expectant mothers in relation to pregnancy during pregnancy. 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
- Anxiety, Pregnancy Related
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2022to 1 Mar 2023
- 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
- Ability to read and understand Turkish
- Being between the ages of 20-35,
- Single pregnancy
- Don't be primiparous
- Having 40 or more from STAI
- Volunteering to participate in the research
- Fully answering survey and scale forms.
- Being in the first, 2nd or 3rd trimester
Who cannot join
- Having been diagnosed with a risky pregnancy
- Unwilling to continue working
- Having a chronic disease (Diabetes, Hypertension, Thyroid etc.),
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Using one of the pharmacological or non-pharmacological methods to reduce anxiety and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
- Lack of a smart phone and internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mandala Coloring on Anxiety in Pregnant Women: Randomized Controlled Experimental Study
This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt by expectant mothers in relation to pregnancy during pregnancy.
Read the detailed description
Pregnancy is an important period in a woman's life in which she experiences different spiritual, physical and emotional experiences. While experiencing this process, women may face many factors that may affect their mental health, such as stress, anxiety and depression. When the literature is examined, it is stated that approximately 10% to 24.2% of pregnant women experience anxiety or stress during their pregnancy.It is very important to diagnose it in the early stages of pregnancy, as anxiety in pregnancy can have negative effects on maternal and newborn health, especially in the birth and postpartum period.
A number of alternatives have been found to reduce anxiety, one of which is using it in the form of art therapy.In the opinion of art psychotherapists, mandala painting is one of the main tools of other art psychotherapy techniques that focus on healing.A number of studies have been conducted to determine the effect of drawing or coloring a mandala on anxiety.
Amelia et al conducted research that proved that drawing and coloring mandalas effectively reduces students' anxiety levels. In Turkey, a study was conducted by Sezen and Ünsalver on the fear of childbirth in pregnant women, including art therapy. In the study, 7 types of art therapy were applied to the women, including listening to music and singing, making masks, drawing, making mandalas, making dolls, taking photographs and making collages. As a result of the research, it was determined that art therapy was effective in reducing anxiety.
When the studies are examined, there are studies on the application of mandala to reduce the anxiety felt by children in cancer patients, but there are no studies on reducing pregnancy-related anxiety of women during pregnancy. This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt by expectant mothers in relation to pregnancy during pregnancy.
- Conditions
- Anxiety, Pregnancy Related
- Being tested
- Mandala coloring
- Keywords
- pregnancy, anxiety, 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
Participants will be asked to choose the pages they want from 12 colored felt-tip pen paint sets and 16 mandala coloring pages given to each participant by the researcher for 1 month, 2 days a week, at any time of the day and for an average of 20-30 minutes each time, and paint them in the colors they want.
| Study group | Role | What they receive |
|---|---|---|
| Mandala coloring group | Experimental | Mandala painting will be applied to pregnant women who have anxiety related to pregnancy. Receives: Other: Mandala coloring |
| Control group | No intervention | Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information form
A form that includes questions about women's socio-demographic and pregnancy and characteristics.
Measured: between one to six months
the Spielberger State-Trait Anxiety Inventory (STAI) scale
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.
Measured: between one to six months
Pregnancy-related anxiety scale
This scale was developed by Brunton, whose validity and reliability in Turkish were made by Şolt and Gül. As the score obtained from the scale increases, the level of pregnancy-related anxiety increases. It will be used to assess pregnancy-related anxiety. As the score obtained in the scale consisting of 9 sub-dimensions increases, it is determined that the anxiety of the pregnant woman is also higher.
Measured: between one to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start11 Nov 2022
- Primary completion15 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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 clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- Elif Dağlı, Phd, Principal investigator, Cukurova UniversityAYÇA ŞOLT KIRCA, Phd, Study director, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534867
- Sponsor's protocol ID
- KırklareliAS-6
- Status last verified
- Mar 2023
- First submitted
- 5 Sep 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solt Kirca A, Dagli E. The effect of mandala coloring on pregnancy-related anxiety. Eur J Obstet Gynecol Reprod Biol. 2024 Jan;292:251-258. doi: 10.1016/j.ejogrb.2023.11.035. Epub 2023 Dec 1.
PubMed 38056411
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mandala Coloring on Anxiety in Pregnant Women: Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT05534867
- Acronym / sponsor ID
- KırklareliAS-6
- Conditions
- Anxiety, Pregnancy Related
- Keywords
- pregnancy, anxiety, mandala coloring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Collaborators
- Cukurova University
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 10 Sep 2022 (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 research was planned as a randomized controlled experimental study in order to reduce the anxiety felt by expectant mothers in relation to pregnancy during pregnancy.
Detailed description
Pregnancy is an important period in a woman's life in which she experiences different spiritual, physical and emotional experiences. While experiencing this process, women may face many factors that may affect their mental health, such as stress, anxiety and depression. When the literature is examined, it is stated that approximately 10% to 24.2% of pregnant women experience anxiety or stress during their pregnancy.It is very important to diagnose it in the early stages of pregnancy, as anxiety in pregnancy can have negative effects on maternal and newborn health, especially in the birth and postpartum period.
A number of alternatives have been found to reduce anxiety, one of which is using it in the form of art therapy.In the opinion of art psychotherapists, mandala painting is one of the main tools of other art psychotherapy techniques that focus on healing.A number of studies have been conducted to determine the effect of drawing or coloring a mandala on anxiety.
Amelia et al conducted research that proved that drawing and coloring mandalas effectively reduces students' anxiety levels. In Turkey, a study was conducted by Sezen and Ünsalver on the fear of childbirth in pregnant women, including art therapy. In the study, 7 types of art therapy were applied to the women, including listening to music and singing, making masks, drawing, making mandalas, making dolls, taking photographs and making collages. As a result of the research, it was determined that art therapy was effective in reducing anxiety.
When the studies are examined, there are studies on the application of mandala to reduce the anxiety felt by children in cancer patients, but there are no studies on reducing pregnancy-related anxiety of women during pregnancy. This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt by expectant mothers in relation to pregnancy during pregnancy.
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 clinical trial
| Arm | Type | Receives |
|---|---|---|
| Mandala coloring group | Experimental | Other: Mandala coloringMandala painting will be applied to pregnant women who have anxiety related to pregnancy. |
| Control group | No intervention | –Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ability to read and understand Turkish
- Being between the ages of 20-35,
- Single pregnancy
- Don't be primiparous
- Having 40 or more from STAI
Key exclusion criteria (6 listed)
- Having been diagnosed with a risky pregnancy
- Unwilling to continue working
- Having a chronic disease (Diabetes, Hypertension, Thyroid etc.),
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Using one of the pharmacological or non-pharmacological methods to reduce anxiety and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
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 coloringParticipants will be asked to choose the pages they want from 12 colored felt-tip pen paint sets and 16 mandala coloring pages given to each participant by the researcher for 1 month, 2 days a week, at any time of the day and for an average of 20-30 minutes each time, and paint them in the colors they want. | Other | Mandala coloring group |
Primary outcome
Introductory Information form
Time frame: between one to six months
A form that includes questions about women's socio-demographic and pregnancy and characteristics.
the Spielberger State-Trait Anxiety Inventory (STAI) scale
Time frame: between one to six months
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.
Pregnancy-related anxiety scale
Time frame: between one to six months
This scale was developed by Brunton, whose validity and reliability in Turkish were made by Şolt and Gül. As the score obtained from the scale increases, the level of pregnancy-related anxiety increases. It will be used to assess pregnancy-related anxiety. As the score obtained in the scale consisting of 9 sub-dimensions increases, it is determined that the anxiety of the pregnant woman is also higher.
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 14 Mar 2023.
- Derived from this study: PubMed 38056411Solt Kirca A, Dagli E. The effect of mandala coloring on pregnancy-related anxiety. Eur J Obstet Gynecol Reprod Biol. 2024 Jan;292:251-258. doi: 10.1016/j.ejogrb.2023.11.035. Epub 2023 Dec 1.
- Individual participant dataSharing planned: No
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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.
Elif Dağlı, Phd principal investigator
Cukurova University
AYÇA ŞOLT KIRCA, Phd study director
Kırklareli University
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 Anxiety and Pregnancy Related, run by Kırklareli 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 8 inclusion and 6 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 14 Mar 2023. 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?
Introductory Information form (time frame: between one to six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534867, which also lists 1 linked publication.
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 14 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.