NCT06637891

Brief Summary

One of the art therapy techniques that can provide psychological support and healing is mandala painting. Mandala is a Sanskrit word meaning 'circle'. The purpose of the circle is to encourage meditation, concentration and integration by narrowing or limiting the visual field towards the centre. In mandala painting, the individual can focus on the lines, stay in the moment, separate themselves from the concerns of the past and future and allow them to recall the consciousness of the moment. Studies in the literature have reported that making mandalas is an effective method for reducing negative mood and anxiety in people.This study was planned as a randomized controlled study to help women who experience postpartum sadness get through this period more easily.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

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

October 5, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

October 5, 2024

Last Update Submit

March 14, 2025

Conditions

Keywords

Mandala coloringpostpartum blues

Outcome Measures

Primary Outcomes (3)

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

    A form that includes questions about women's socio-demographic and pregnancy and characteristics. The survey consists of questions covering the personal characteristics, obstetric characteristics and psycho-social characteristics of new mothers.

    between 1 to 4 weeks

  • Stein Blues Scale

    The scale consists of two sections with a total of 13 questions. The first eight questions are Likert-type questions that examine mood symptoms. The second section investigates the presence of symptoms of headache, restlessness, difficulty in concentration, forgetfulness and confusion with five questions answered with yes/no. The scoring of the section with Likert-type questions varies between 0 and 4, and if there are symptoms in the last five questions, 1 point is added to the total score for each. The minimum score is 0, and the maximum score is 26. Patients are asked to answer the scale thinking only about that day.

    between 1 to 4 weeks

  • Edinburgh Postpartum Depression Scale

    Responses to the 4-point Likert-type scale consisting of ten questions are scored between 0 and 3. The cut-off score for the scale is taken as 12/13. If the score is 12 and below, the patient is not considered at risk for postpartum depression, and if it is 13 and above, the patient is considered at risk for postpartum depression. Scores from 0 to 30 are taken from the scale.

    between 1 to 4 weeks

Study Arms (2)

Mandala coloring group

EXPERIMENTAL

Mandala painting will be applied to postpartum women who have postpartum blues

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 postpartum blues symptoms.

Interventions

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 2 weeks, 3 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:

  • Between the ages of 18-35,
  • Being between the 1st and 14th days postpartum
  • Being able to read, understand and write Turkish,
  • Having given birth at term (single birth at 38 weeks and above),
  • Having given birth by normal vaginal delivery or cesarean section after an uncomplicated pregnancy
  • Scoring 13 points or above on the Edinburgh Postpartum Depression Scale
  • Scoring 3 points or above on the Stein Blues Scale
  • Having stable vital signs, not having undergone infertility treatment, not having a chronic disease (such as hypertension, diabetes), not experiencing severe depression, anxiety and stress, not having any chronic disease or not having a disease that may cause cognitive impairment (such as delirium, dementia, mental retardation), not having serious complications in the mother and volunteering to participate in the study will be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, PostpartumDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • ELIF DAGLI, P

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate professor

Study Record Dates

First Submitted

October 5, 2024

First Posted

October 15, 2024

Study Start

October 10, 2024

Primary Completion

March 3, 2025

Study Completion

March 3, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations