Pregnancy RelatedNCT05705609
The Effect of Mandala Art Therapy on Pregnant Women With Abnormal OGTT
A study testing Mandala art therapy in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Mandala art therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2022to 20 Jan 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- at 24-28 weeks of gestation,
- OGTT will be done,
- Those who have not received mandala art therapy training before,
- Does not have a physical problem that will prevent creating a mandala,
- Actively using their hands
- No communication problem
- Pregnant women without learning problems were included in the sample
Who cannot join
- Any problems diagnosed in pregnancy (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
- Pregnant women diagnosed with gestational diabetes
- Pregnant women in their first term were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandala Art Therapy on Blood Glucose Level, Mood and Anxiety in Pregnant Women With Abnormal OGTT: A Randomized Controlled Study
The goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value. The main questions it aims to answer are:
- Does mandala art therapy affect the mood of pregnant women?
- Does mandala art therapy affect the anxiety level of pregnant women?
After measuring fasting plasma glucose and drinking oral glucose by the hospital staff in the experimental group in the outpatient clinic, after the 1st and 2nd hour measurements, a total of 2 individual mandala activities (Mandala training certificate was obtained by Dr. Lecturer Esra KARATAŞ OKYAY) will be performed by the researcher.
Read the detailed description
The goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value.
Pregnant women who apply to Malatya Training and Research Hospital gynecology outpatient clinics to have OGTT and meet the criteria will be invited to the study. The women will be informed about the method to be followed in the research, the voluntary information form will be read to those who want to participate in the research, and their verbal and written permissions will be obtained. Before Mandala art therapy, a personal information form, State Meta-Mood Scale (SMMS) and State Trait Anxiety Scale (STAI) will be applied to pregnant women in both groups. All blood collection and OGTT procedures for pregnant women in the experimental and control groups will be performed by hospital staff in line with hospital procedures. After measuring fasting plasma glucose and drinking oral glucose by the hospital staff in the experimental group in the outpatient clinic, after the 1st and 2nd hour measurements, a total of 2 individual mandala activities (Mandala training certificate was obtained by one of researcher Esra KARATAŞ OKYAY) will be performed by the researcher. The blood glucose levels of the pregnant woman at the time of measurement will be recorded from the patient records. As a post-test, the State Meta-Mood Scale (SMMS) and state anxiety scale will be applied again. Any procedure other than routine care will not be applied to the pregnant women in the control group. Likewise, the blood glucose levels of the pregnant woman at the time of measurement will be recorded from the patient records. As a post-test, the State Meta-Mood Scale (SMMS) and StateTrait Anxiety Scale (STAI) will be applied again.
- Conditions
- Pregnancy Related
- Being tested
- Mandala art therapy
- Keywords
- Pregnant Women, Oral Glucose Tolerance Test, Anxiety, Affect
- 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 art therapyOther
A mandala is a geometric configuration of symbols. In various spiritual traditions, mandalas may be employed for focusing attention of practitioners and adepts, as a spiritual guidance tool, for establishing a sacred space and as an aid to meditation and trance induction. Mandalas are used effectively in the field of art therapy. The possibility of using mandala in all age groups has contributed to the treatment process of different diseases and disorders, and its effectiveness has been presented to the scientific world with many researches around the globe. As a result of using mandala as an art therapy in adults, mandala has been used both in the treatment of psychiatric disorders and has been a tool used to observe the effects of the treatments. Art therapy which included drawing mandala, significantly reduced the severity of trauma symptoms in individuals with anxiety disorders and post-traumatic stress disorder.
| Study group | Role | What they receive |
|---|---|---|
| Mandala art therapy | Experimental | Mandala art therapy applied group Receives: Other: Mandala art therapy |
| Standard of care | No intervention | group without Mandala art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety scores
StateTrait Anxiety Scale (STAI): The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels
Measured: at 1st hours after OGTT
Anxiety scores
StateTrait Anxiety Scale (STAI): The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels
Measured: at 2nd hours after OGTT
Secondary outcomes (2)
Mood scores
State Meta-Mood Scale: The highest score from the scale is 32, the lowest score is 8. High scores indicate high mood
Measured: at 1st hours after OGTT
Mood scores
State Meta-Mood Scale: The highest score from the scale is 32, the lowest score is 8. High scores indicate high mood
Measured: at 2nd hours after OGTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start20 Dec 2022
- Primary completion23 Dec 2022
- Study completion20 Jan 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 Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Crossover
- Model description
- randomized controlled trial conducted with experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA GUNEY, PhD, Inonu University
- Investigators
- ESRA GÜNEY, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705609
- Sponsor's protocol ID
- 2022/3679
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared.
Publications
Kim H, Kim S, Choe K, Kim JS. Effects of Mandala Art Therapy on Subjective Well-being, Resilience, and Hope in Psychiatric Inpatients. Arch Psychiatr Nurs. 2018 Apr;32(2):167-173. doi: 10.1016/j.apnu.2017.08.008. Epub 2017 Aug 24.
PubMed 29579508
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Art Therapy on Blood Glucose Level, Mood and Anxiety in Pregnant Women With Abnormal OGTT: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05705609
- Acronym / sponsor ID
- 2022/3679
- Conditions
- Pregnancy Related
- Keywords
- Pregnant Women, Oral Glucose Tolerance Test, Anxiety, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 31 Jan 2023 (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 goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value. The main questions it aims to answer are:
- Does mandala art therapy affect the mood of pregnant women?
- Does mandala art therapy affect the anxiety level of pregnant women?
After measuring fasting plasma glucose and drinking oral glucose by the hospital staff in the experimental group in the outpatient clinic, after the 1st and 2nd hour measurements, a total of 2 individual mandala activities (Mandala training certificate was obtained by Dr. Lecturer Esra KARATAŞ OKYAY) will be performed by the researcher.
Detailed description
The goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value.
Pregnant women who apply to Malatya Training and Research Hospital gynecology outpatient clinics to have OGTT and meet the criteria will be invited to the study. The women will be informed about the method to be followed in the research, the voluntary information form will be read to those who want to participate in the research, and their verbal and written permissions will be obtained. Before Mandala art therapy, a personal information form, State Meta-Mood Scale (SMMS) and State Trait Anxiety Scale (STAI) will be applied to pregnant women in both groups. All blood collection and OGTT procedures for pregnant women in the experimental and control groups will be performed by hospital staff in line with hospital procedures. After measuring fasting plasma glucose and drinking oral glucose by the hospital staff in the experimental group in the outpatient clinic, after the 1st and 2nd hour measurements, a total of 2 individual mandala activities (Mandala training certificate was obtained by one of researcher Esra KARATAŞ OKYAY) will be performed by the researcher. The blood glucose levels of the pregnant woman at the time of measurement will be recorded from the patient records. As a post-test, the State Meta-Mood Scale (SMMS) and state anxiety scale will be applied again. Any procedure other than routine care will not be applied to the pregnant women in the control group. Likewise, the blood glucose levels of the pregnant woman at the time of measurement will be recorded from the patient records. As a post-test, the State Meta-Mood Scale (SMMS) and StateTrait Anxiety Scale (STAI) will be applied again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Mandala art therapy | Experimental | Other: Mandala art therapyMandala art therapy applied group |
| Standard of care | No intervention | –group without Mandala art therapy |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- at 24-28 weeks of gestation,
- OGTT will be done,
- Those who have not received mandala art therapy training before,
- Does not have a physical problem that will prevent creating a mandala,
- Actively using their hands
Key exclusion criteria (3 listed)
- Any problems diagnosed in pregnancy (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
- Pregnant women diagnosed with gestational diabetes
- Pregnant women in their first term were not included in 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 art therapyA mandala is a geometric configuration of symbols. In various spiritual traditions, mandalas may be employed for focusing attention of practitioners and adepts, as a spiritual guidance tool, for establishing a sacred space and as an aid to meditation and trance induction. Mandalas are used effectively in the field of art therapy. The possibility of using mandala in all age groups has contributed to the treatment process of different diseases and disorders, and its effectiveness has been presented to the scientific world with many researches around the globe. As a result of using mandala as an art therapy in adults, mandala has been used both in the treatment of psychiatric disorders and has been a tool used to observe the effects of the treatments. Art therapy which included drawing mandala, significantly reduced the severity of trauma symptoms in individuals with anxiety disorders and post-traumatic stress disorder. | Other | Mandala art therapy |
Primary outcome
Anxiety scores
Time frame: at 1st hours after OGTT
StateTrait Anxiety Scale (STAI): The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels
Anxiety scores
Time frame: at 2nd hours after OGTT
StateTrait Anxiety Scale (STAI): The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels
2 secondary outcomes
Mood scores
Time frame: at 1st hours after OGTT
Mood scores
Time frame: at 2nd hours after OGTT
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 7 Sep 2023.
- Results publication: PubMed 29579508Kim H, Kim S, Choe K, Kim JS. Effects of Mandala Art Therapy on Subjective Well-being, Resilience, and Hope in Psychiatric Inpatients. Arch Psychiatr Nurs. 2018 Apr;32(2):167-173. doi: 10.1016/j.apnu.2017.08.008. Epub 2017 Aug 24.
- Reference linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Research results will be shared.
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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.
ESRA GÜNEY, PhD principal investigator
Inonu 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 art therapy in people with Pregnancy Related, run by Inonu 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 3 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 7 Sep 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?
Anxiety scores (time frame: at 1st hours after OGTT). The study lists 2 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 NCT05705609, 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 7 Sep 2023.