Clinical trial NCT05705609: The Effect of Mandala Art Therapy on Pregnant Women With Abnormal OGTT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Pregnant Women
Oral Glucose Tolerance Test
Anxiety
Affect
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: İnönü University
First posted: 2023-01-31
Enrollment: 68
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled trial conducted with experimental and control groups.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety scores
timeFrame: at 1st hours after OGTT
measure: Anxiety scores
timeFrame: at 2nd hours after OGTT
Secondary outcomes:
measure: Mood scores
timeFrame: at 1st hours after OGTT
measure: Mood scores
timeFrame: at 2nd hours after OGTT
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: ESRA GÜNEY, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.