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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05705609
Other study ID # 2022/3679
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2022
Est. completion date January 20, 2023

Study information

Verified date January 2023
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date January 20, 2023
Est. primary completion date December 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mandala art therapy
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.

Locations

Country Name City State
Turkey Inonu University Malatya

Sponsors (2)

Lead Sponsor Collaborator
Inonu University Inönü University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at 1st hours after OGTT
Primary 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 at 2nd hours after OGTT
Secondary Mood scores State Meta-Mood Scale: The highest score from the scale is 32, the lowest score is 8. High scores indicate high mood at 1st hours after OGTT
Secondary Mood scores State Meta-Mood Scale: The highest score from the scale is 32, the lowest score is 8. High scores indicate high mood at 2nd hours after OGTT
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