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

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT05705609
Collaborator
(none)
68
1
2
1
66.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mandala art therapy
N/A

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

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
randomized controlled trial conducted with experimental and control groups.randomized controlled trial conducted with experimental and control groups.
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Dec 20, 2022
Actual Primary Completion Date :
Dec 23, 2022
Actual Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mandala art therapy

Mandala art therapy applied group

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.

No Intervention: Standard of care

group without Mandala art therapy

Outcome Measures

Primary Outcome Measures

  1. Anxiety scores [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 [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 Outcome Measures

  1. Mood scores [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inonu University Malatya Turkey

Sponsors and Collaborators

  • Inonu University

Investigators

  • Principal Investigator: ESRA GÜNEY, PhD, Inonu University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
ESRA GUNEY, PhD, PhD, Inonu University
ClinicalTrials.gov Identifier:
NCT05705609
Other Study ID Numbers:
  • 2022/3679
First Posted:
Jan 31, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ESRA GUNEY, PhD, PhD, Inonu University

Study Results

No Results Posted as of Jan 31, 2023