Anxiety During PregnancyNCT06589648
The Effect of Mandala Coloring on Anxiety and Mental Fatigue in Pregnant Women Diagnosed With Threatened Preterm Labor
A study testing mandala painting in people with Anxiety During Pregnancy and Mental Fatigue, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted in a pre-test-post-test control group randomized control design. The aim is to examine the effect of mandala work on anxiety and mental fatigue in pregnant women diagnosed with threatened preterm labor. Hypotheses 1. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety During Pregnancy, Mental Fatigue, Mandala
- What is being tested?
- mandala painting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 10 Apr 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women who can read and write Turkish,
- Diagnosed with threatened preterm labor,
- Are between 32-36 weeks of gestation,
- Primiparous,
- Hospitalized,
- Open to communication (able to understand and answer questions) will be included in the sample.
Who cannot join
- Pregnant women with a history of miscarriage or stillbirth,
- Those who voluntarily withdrew from the study,
- Those with a history of psychiatric illness (self-report),
- Those who do not have a physical disability that would prevent them from coloring mandalas will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Medical Faculty Hospital
Konya, Konya/ Selçuklu, 42080
About this study
Official title: The Effect of Mandala Coloring on Anxiety and Mental Fatigue Levels in Pregnant Women Diagnosed With Threatened Preterm Labor: A Randomized Controlled Trial
The research will be conducted in a pre-test-post-test control group randomized control design. The aim is to examine the effect of mandala work on anxiety and mental fatigue in pregnant women diagnosed with threatened preterm labor. Hypotheses
- Mandala coloring work reduces the level of anxiety related to pregnancy in pregnant women diagnosed with threatened preterm labor.
- Mandala coloring work reduces the level of anxiety in pregnant women diagnosed with threatened preterm labor.
- Mandala coloring work reduces the level of mental fatigue in pregnant women diagnosed with threatened preterm labor.
Read more
Pregnant women who meet the inclusion criteria will be given general information about the research before randomization, their consent will be obtained and pre-test data will be collected. Pregnant women whose pre-test data are collected will be assigned to the intervention and control groups using the simple randomization method.
Intervention group: Participants in the intervention group will be given a set of colored markers and a mandala coloring page and will be asked to color them at any time of the day and in any way they want during their hospitalization. Participants will be asked to take a picture of the mandala they colored and send it to the researcher after they are finished. Participants will be reminded daily so that they do not forget to do the activity. Research data will be collected a total of four times before randomization, on the 1st day, 2nd day and 3rd day after the mandala application was started.
Control Group: No intervention other than routine care will be made to the control group of the study, and research data will be collected at simultaneous time intervals with the experimental group.
- Conditions
- Anxiety During Pregnancy, Mental Fatigue, Mandala
- Being tested
- mandala painting
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandala paintingOther
Mandala coloring creates a relaxing effect on individuals because it starts with a pattern that develops like a flower around a point; it allows the individual to stay in the moment, to get away from stress, anxiety and worries, and it relaxes the mind.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants in the intervention group will be given a set of colored markers and a mandala coloring page and will be asked to color them any time of the day and in any way they want during their hospital stay. Participants will be asked to take a picture of the mandala they colored and send it to the researcher after they are finished. Participants will be reminded daily so that they do not forget to do the activity. Receives: Other: mandala painting |
| control group | No intervention | No intervention other than routine care will be made to the control group of the study, and research data will be collected at simultaneous intervals with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-Related Anxiety Scale
It was developed by Brunton et al. (2019), which can be applied to primiparous and multiparous pregnant women, and adapted into Turkish by Şolt and Kanza Gül (2020). The scale is a 4-point Likert-type scale with 9 sub-dimensions: "Birth-Related Anxiety" (items 1, 2, 3, 4, 5, and 6), "Body Image Anxiety" (items 7, 8, 9, 10, and 11), "Attitudes Towards Birth" (items 12, 13, 14), "Concerns About Motherhood" (items 15, 16, 17), "Acceptance of Pregnancy" (items 18, 19, 20), "Anxiety Indicators" (items 21, 22, 23, and 24), "Attitudes Towards Healthcare Personnel" (items 25, 26, and 27), "Avoidance" (items 28, 29, and 30) and "Attitudes Towards the Baby" (items 29, 30, and 40). It consists of a total of 33 items, including "Anxiety" (items 31, 32 and 33). The lowest score is 33 and the highest is 132, and there is no cut-off point. As the scores obtained from the scale increase, anxiety related to pregnancy increases. The Cronbach Alpha coefficient of the scale was stated as 0.82 for multipa
Measured: 0-3 day
Secondary outcomes (1)
State Anxiety Inventory
It is a scale consisting of 20 questions developed by Speilberger et al. (1983) (Öner, 1997; Öner \& Le Compte, 1985). It was adapted to Turkish by Öner and Le Compte (1974-1977) (Öner, 1997; Öner \& Le Compte, 1985). The emotions or behaviors expressed in the items of the scale consist of the following options according to the severity of the experience: 1) Not at all, 2) A little, 3) A lot, and 4) Completely. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 of the scale are reverse-coded. The total score obtained from the scale varies between 20 and 80 (Öner, 1997; Öner \& Le Compte, 1985). A high score indicates a high level of anxiety, a low score indicates a low level of anxiety.
Measured: 0-3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion4 Sep 2024
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety During PregnancyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- mandala coloring
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cennet Nur Bircan, KTO Karatay University
- Investigators
- Karakoç, Study director, KTO Karatay Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589648
- Sponsor's protocol ID
- KTO- Midwifery- C.N.Bircan-001
- Status last verified
- May 2025
- First submitted
- 6 Sep 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring on Anxiety and Mental Fatigue Levels in Pregnant Women Diagnosed With Threatened Preterm Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06589648
- Acronym / sponsor ID
- KTO- Midwifery- C.N.Bircan-001
- Conditions
- Anxiety During Pregnancy, Mental Fatigue, Mandala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (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.
The research will be conducted in a pre-test-post-test control group randomized control design. The aim is to examine the effect of mandala work on anxiety and mental fatigue in pregnant women diagnosed with threatened preterm labor. Hypotheses
- Mandala coloring work reduces the level of anxiety related to pregnancy in pregnant women diagnosed with threatened preterm labor.
- Mandala coloring work reduces the level of anxiety in pregnant women diagnosed with threatened preterm labor.
- Mandala coloring work reduces the level of mental fatigue in pregnant women diagnosed with threatened preterm labor.
Pregnant women who meet the inclusion criteria will be given general information about the research before randomization, their consent will be obtained and pre-test data will be collected. Pregnant women whose pre-test data are collected will be assigned to the intervention and control groups using the simple randomization method.
Intervention group: Participants in the intervention group will be given a set of colored markers and a mandala coloring page and will be asked to color them at any time of the day and in any way they want during their hospitalization. Participants will be asked to take a picture of the mandala they colored and send it to the researcher after they are finished. Participants will be reminded daily so that they do not forget to do the activity. Research data will be collected a total of four times before randomization, on the 1st day, 2nd day and 3rd day after the mandala application was started.
Control Group: No intervention other than routine care will be made to the control group of the study, and research data will be collected at simultaneous time intervals with the experimental group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- mandala coloring
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: mandala paintingParticipants in the intervention group will be given a set of colored markers and a mandala coloring page and will be asked to color them any time of the day and in any way they want during their hospital stay. Participants will be asked to take a picture of the mandala they colored and send it to the researcher after they are finished. Participants will be reminded daily so that they do not forget to do the activity. |
| control group | No intervention | –No intervention other than routine care will be made to the control group of the study, and research data will be collected at simultaneous intervals with the experimental group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women who can read and write Turkish,
- Diagnosed with threatened preterm labor,
- Are between 32-36 weeks of gestation,
- Primiparous,
- Hospitalized,
Key exclusion criteria (4 listed)
- Pregnant women with a history of miscarriage or stillbirth,
- Those who voluntarily withdrew from the study,
- Those with a history of psychiatric illness (self-report),
- Those who do not have a physical disability that would prevent them from coloring mandalas will be excluded from the study.
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 paintingMandala coloring creates a relaxing effect on individuals because it starts with a pattern that develops like a flower around a point; it allows the individual to stay in the moment, to get away from stress, anxiety and worries, and it relaxes the mind. | Other | intervention group |
Primary outcome
Pregnancy-Related Anxiety Scale
Time frame: 0-3 day
It was developed by Brunton et al. (2019), which can be applied to primiparous and multiparous pregnant women, and adapted into Turkish by Şolt and Kanza Gül (2020). The scale is a 4-point Likert-type scale with 9 sub-dimensions: "Birth-Related Anxiety" (items 1, 2, 3, 4, 5, and 6), "Body Image Anxiety" (items 7, 8, 9, 10, and 11), "Attitudes Towards Birth" (items 12, 13, 14), "Concerns About Motherhood" (items 15, 16, 17), "Acceptance of Pregnancy" (items 18, 19, 20), "Anxiety Indicators" (items 21, 22, 23, and 24), "Attitudes Towards Healthcare Personnel" (items 25, 26, and 27), "Avoidance" (items 28, 29, and 30) and "Attitudes Towards the Baby" (items 29, 30, and 40). It consists of a total of 33 items, including "Anxiety" (items 31, 32 and 33). The lowest score is 33 and the highest is 132, and there is no cut-off point. As the scores obtained from the scale increase, anxiety related to pregnancy increases. The Cronbach Alpha coefficient of the scale was stated as 0.82 for multipa
1 secondary outcome
State Anxiety Inventory
Time frame: 0-3 day
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 6 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Karakoç study director
KTO Karatay Univeristy
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 painting in people with Anxiety During Pregnancy and Mental Fatigue, run by KTO Karatay 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 6 inclusion and 4 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 6 May 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?
Pregnancy-Related Anxiety Scale (time frame: 0-3 day). 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 6 May 2025.