NCT06804018

Brief Summary

Maintaining well-being during pregnancy, reducing anxiety and supporting self-compassion are critical for the health of expectant mothers and the development of the baby. In addition to traditional medicine, alternative therapeutic approaches have been increasingly popular in recent years as a supportive approach during pregnancy. Among these alternative methods, creative activities such as mandala painting have the potential to reduce stress, increase mental focus and provide emotional balance. H1: There is a difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy. H0: There is no difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy. Sub-Hypotheses of the Study: H1-1: There is a difference in well-being between primiparous pregnant women who painted mandalas and those who did not during pregnancy. H1-2: There is a difference in self-compassion levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy. H1-3: There is a difference in anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

January 13, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

Pregnant womenanxietywell beingself compassionmandala coloring

Outcome Measures

Primary Outcomes (1)

  • Anxiety Scale

    The State Anxiety Inventory (STAI-X) will be used to determine the anxiety status of pregnant women.

    5 weeks

Secondary Outcomes (1)

  • Well-being

    5 weeks

Other Outcomes (1)

  • Self-Compassion

    5 weeks

Study Arms (2)

Intervention Group (pregnant women who will paint mandalas)

EXPERIMENTAL

Each participant in the intervention group will be given 12 different colored felt-tip pens or 12 different colored crayons (whichever the pregnant woman wishes) and mandala pictures taken by the researcher. They will be asked to choose the pictures they will color, and the pregnant women will be given mandalas with various patterns. They will be asked to color for an average of 20-30 minutes two days a week (on the day and time period they want). They will be told that they can do their coloring in an environment they want, that they will not have others do their coloring, and that they will not be called back to the hospital for coloring. A reminder message\* will be sent by the researcher according to the determined days before each coloring, and photos of the colored mandalas will be sent to the researcher via WhatsApp after coloring. Afterwards, it will be explained that the STAI form, the Well-being in Pregnancy Scale, and the Self-Compassion Scale will need to be filled out a to

Other: Mandala coloring

Control Group

NO INTERVENTION

For the control group, the scales and forms will be filled out at the end of the second and fourth weeks. Pregnant women will be asked to fill out the forms at the end of the second and fourth weeks and send them to the researcher via WhatsApp, and they will not be invited to a face-to-face interview again.

Interventions

Pregnant women who will paint mandalas

Intervention Group (pregnant women who will paint mandalas)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-35
  • Being in the last three months of pregnancy (Amelia et al., 2020)
  • Getting a State Anxiety Inventory (STAI) score of ≥40
  • Having a smartphone and internet connection
  • Being willing to participate in the study
  • Being spontaneously pregnant
  • Not having a diagnosed health risk (diabetes, preeclampsia, fetal anomaly, etc.) in the mother or fetus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Erbaa, Tokat Province, 60500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The data from the study will be examined by an independent statistician. The person doing the analysis will not know the groups. Pregnant women included in the study will later learn which group they are in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 31, 2025

Study Start

May 5, 2025

Primary Completion

June 5, 2025

Study Completion

June 5, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Supporting information: CSR

Shared Documents
CSR

Locations