NCT05705609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

September 7, 2023

Status Verified

January 1, 2023

Enrollment Period

3 days

First QC Date

January 20, 2023

Last Update Submit

September 5, 2023

Conditions

Pregnancy Related

Keywords

Pregnant WomenOral Glucose Tolerance TestAnxietyAffect

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Mood scores

    at 1st hours after OGTT

  • Mood scores

    at 2nd hours after OGTT

Study Arms (2)

Mandala art therapy

EXPERIMENTAL

Mandala art therapy applied group

Other: Mandala art therapy

Standard of care

NO INTERVENTION

group without Mandala art therapy

Interventions

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.

Mandala art therapy

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related 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.

    PMID: 29579508RESULT

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • ESRA GÜNEY, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: randomized controlled trial conducted with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

December 20, 2022

Primary Completion

December 23, 2022

Study Completion

January 20, 2023

Last Updated

September 7, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Research results will be shared.

Available IPD Datasets

Informed Consent Form (Kim H, Kim S, Choe K, Kim JS)Access

Locations

TU(1)