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Completed

NCT Number: NCT05705609

The Effect of Mandala Art Therapy on Pregnant Women With Abnormal OGTT

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.

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Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Turkey (Türkiye)

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mandala Art Therapy

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Mood scores

    Time frame: at 1st hours after OGTT

    State Meta-Mood Scale: The highest score from the scale is 32, the lowest score is 8. High scores indicate high mood

  2. Mood scores

    Time frame: at 2nd hours after OGTT

    State Meta-Mood Scale: The highest score from the scale is 32, the lowest score is 8. High scores indicate high mood

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Collaborators

  • İnönü University

Registry information

Official study title

The Effect of Mandala Art Therapy on Blood Glucose Level, Mood and Anxiety in Pregnant Women With Abnormal OGTT: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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