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Effects of Mandala Coloring on Anxiety in Pregnant Women

Primary Purpose

Anxiety, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mandala coloring
Sponsored by
Kırklareli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring pregnancy, anxiety, mandala coloring

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability to read and understand Turkish
  • Being between the ages of 20-35,
  • Single pregnancy
  • Don't be primiparous
  • Having 40 or more from STAI
  • Volunteering to participate in the research
  • Fully answering survey and scale forms.
  • Being in the first, 2nd or 3rd trimester

Exclusion Criteria:

  • Having been diagnosed with a risky pregnancy
  • Unwilling to continue working
  • Having a chronic disease (Diabetes, Hypertension, Thyroid etc.),
  • Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
  • Using one of the pharmacological or non-pharmacological methods to reduce anxiety and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
  • Lack of a smart phone and internet

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mandala coloring group

Control group

Arm Description

Mandala painting will be applied to pregnant women who have anxiety related to pregnancy.

Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms.

Outcomes

Primary Outcome Measures

Introductory Information form
A form that includes questions about women's socio-demographic and pregnancy and characteristics.
the Spielberger State-Trait Anxiety Inventory (STAI) scale
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.
Pregnancy-related anxiety scale
This scale was developed by Brunton, whose validity and reliability in Turkish were made by Şolt and Gül. As the score obtained from the scale increases, the level of pregnancy-related anxiety increases. It will be used to assess pregnancy-related anxiety. As the score obtained in the scale consisting of 9 sub-dimensions increases, it is determined that the anxiety of the pregnant woman is also higher.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2022
Last Updated
March 12, 2023
Sponsor
Kırklareli University
Collaborators
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05534867
Brief Title
Effects of Mandala Coloring on Anxiety in Pregnant Women
Official Title
Effects of Mandala Coloring on Anxiety in Pregnant Women: Randomized Controlled Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
Collaborators
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt by expectant mothers in relation to pregnancy during pregnancy.
Detailed Description
Pregnancy is an important period in a woman's life in which she experiences different spiritual, physical and emotional experiences. While experiencing this process, women may face many factors that may affect their mental health, such as stress, anxiety and depression. When the literature is examined, it is stated that approximately 10% to 24.2% of pregnant women experience anxiety or stress during their pregnancy.It is very important to diagnose it in the early stages of pregnancy, as anxiety in pregnancy can have negative effects on maternal and newborn health, especially in the birth and postpartum period. A number of alternatives have been found to reduce anxiety, one of which is using it in the form of art therapy.In the opinion of art psychotherapists, mandala painting is one of the main tools of other art psychotherapy techniques that focus on healing.A number of studies have been conducted to determine the effect of drawing or coloring a mandala on anxiety. Amelia et al conducted research that proved that drawing and coloring mandalas effectively reduces students' anxiety levels. In Turkey, a study was conducted by Sezen and Ünsalver on the fear of childbirth in pregnant women, including art therapy. In the study, 7 types of art therapy were applied to the women, including listening to music and singing, making masks, drawing, making mandalas, making dolls, taking photographs and making collages. As a result of the research, it was determined that art therapy was effective in reducing anxiety. When the studies are examined, there are studies on the application of mandala to reduce the anxiety felt by children in cancer patients, but there are no studies on reducing pregnancy-related anxiety of women during pregnancy. This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt by expectant mothers in relation to pregnancy during pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pregnancy Related
Keywords
pregnancy, anxiety, mandala coloring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mandala coloring group
Arm Type
Experimental
Arm Description
Mandala painting will be applied to pregnant women who have anxiety related to pregnancy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms.
Intervention Type
Other
Intervention Name(s)
Mandala coloring
Intervention Description
Participants will be asked to choose the pages they want from 12 colored felt-tip pen paint sets and 16 mandala coloring pages given to each participant by the researcher for 1 month, 2 days a week, at any time of the day and for an average of 20-30 minutes each time, and paint them in the colors they want.
Primary Outcome Measure Information:
Title
Introductory Information form
Description
A form that includes questions about women's socio-demographic and pregnancy and characteristics.
Time Frame
between one to six months
Title
the Spielberger State-Trait Anxiety Inventory (STAI) scale
Description
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.
Time Frame
between one to six months
Title
Pregnancy-related anxiety scale
Description
This scale was developed by Brunton, whose validity and reliability in Turkish were made by Şolt and Gül. As the score obtained from the scale increases, the level of pregnancy-related anxiety increases. It will be used to assess pregnancy-related anxiety. As the score obtained in the scale consisting of 9 sub-dimensions increases, it is determined that the anxiety of the pregnant woman is also higher.
Time Frame
between one to six months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ability to read and understand Turkish Being between the ages of 20-35, Single pregnancy Don't be primiparous Having 40 or more from STAI Volunteering to participate in the research Fully answering survey and scale forms. Being in the first, 2nd or 3rd trimester Exclusion Criteria: Having been diagnosed with a risky pregnancy Unwilling to continue working Having a chronic disease (Diabetes, Hypertension, Thyroid etc.), Having any problem that prevents communication (such as hearing, speaking, and understanding abilities), Using one of the pharmacological or non-pharmacological methods to reduce anxiety and receiving psychiatric treatment (Pharmacotherapy or psychotherapy). Lack of a smart phone and internet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Dağlı, Phd
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AYÇA ŞOLT KIRCA, Phd
Organizational Affiliation
Kırklareli University
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Mandala Coloring on Anxiety in Pregnant Women

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