NCT05534867

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable anxiety

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

First Submitted

Initial submission to the registry

September 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

September 5, 2022

Last Update Submit

March 12, 2023

Conditions

AnxietyPregnancy Related

Keywords

pregnancyanxietymandala coloring

Outcome Measures

Primary Outcomes (3)

  • Introductory Information form

    A form that includes questions about women's socio-demographic and pregnancy and characteristics.

    between one to six months

  • 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.

    between one to six months

  • 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.

    between one to six months

Study Arms (2)

Mandala coloring group

EXPERIMENTAL

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

Other: Mandala coloring

Control group

NO INTERVENTION

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

Interventions

Mandala coloringOTHER

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.

Mandala coloring group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

Related Publications (1)

  • Solt Kirca A, Dagli E. The effect of mandala coloring on pregnancy-related anxiety. Eur J Obstet Gynecol Reprod Biol. 2024 Jan;292:251-258. doi: 10.1016/j.ejogrb.2023.11.035. Epub 2023 Dec 1.

    PMID: 38056411DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Elif Dağlı, Phd

    Cukurova University

    PRINCIPAL INVESTIGATOR

  • AYÇA ŞOLT KIRCA, Phd

    Kırklareli University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssistant professor

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 10, 2022

Study Start

November 11, 2022

Primary Completion

February 15, 2023

Study Completion

March 1, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)