The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in NICU

NCT06499259 | Completed

• 1 other identifier: 2024/411
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU).

Conditions

Anxiety; Parents; Psychological Stress

Keywords

Anxiety; Stress; Neonatal Intensive Care Unit; Mandala coloring; Mothers

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.

  Before the first mandala painting session (pre-test)

• Visual Analog Scale (VAS)

  Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.

  After the 7th mandala painting session (7 days after the first session) (post-test)

Secondary Outcomes (2)

• State Trait Anxiety Inventory (STAI)

  Before the first mandala painting session (pre-test)

• State Trait Anxiety Inventory (STAI)

  After the 7th mandala painting session (7 days after the first session) (post-test)

Study Arms (2)

Intervention group

EXPERIMENTAL

Data collection tools will be applied to the mothers in the experimental group and the mandala painting activity will begin. The mandala painting program will consist of a total of 7 mandala painting sessions with 40-minute sessions every day for 7 days. The researcher will accompany the first mandala painting activity. She will answer the participant's questions. The mother will do the remaining 6 mandala coloring sessions alone every day; at the end of the 6 days, the researcher will reapply the data collection tools.

Other: Mandala coloring

Control group

NO INTERVENTION

No application will be made to the mothers in the control group within the scope of the research. Data collection forms will be applied as the first measurement when they are included in the study; at the end of 7 days, the same mothers will fill out the data collection forms again as the last measurement.

Interventions

Mandala coloring OTHER

Mandala Pack and Application: The mandala pack is a pack consisting of 7 different patterns suitable for adults and 12 pencils. Mandala patterns will be photocopied by the researcher. Packages will be given to the mothers about mandala coloring and their questions will be answered. The choice of the color of the paint to be used in mandala coloring will be entirely up to the mother. No guidance will be given in this regard.

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers whose baby has been in the neonatal intensive care unit for at least 3 days and staying in the mother's hotel,
• Having agreed to participate in the research/approved the informed consent form
• No visual or hearing impairment
• Being over 18 years old,
• Being at least literate
• The absence of any problem that would prevent him/her from painting mandala (no problem in his arm or hand that would prevent his movement)
• Must not have a diagnosis of mental illness/anxiety disorder

You may not qualify if:

• Mothers with communication and perception problems will not be included in the study.
• Mothers with comprehension and speech problems will not be included in the study.
• Mothers with psychiatric illness and taking medication will not be included in the study.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (3)

• Sari Ozturk C, Demir K. The Effect of Mandala Activity and Technology-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Mother-Infant Attachment of Primiparous Women: A Randomized Controlled Study. J Med Syst. 2023 Apr 1;47(1):44. doi: 10.1007/s10916-023-01942-3.

  PMID: 37004692 BACKGROUND

• Robinson EM, Baker R, Hossain MM. Randomized Trial Evaluating the Effectiveness of Coloring on Decreasing Anxiety Among Parents in a Pediatric Surgical Waiting Area. J Pediatr Nurs. 2018 Jul-Aug;41:80-83. doi: 10.1016/j.pedn.2018.02.001. Epub 2018 Feb 10.

  PMID: 29439840 BACKGROUND

• Ozsavran M, Ayyildiz TK. The effect of mandala art therapy on the comfort and resilience levels of mothers who have children with special needs: A randomized controlled study. Child Care Health Dev. 2023 Nov;49(6):1032-1045. doi: 10.1111/cch.13110. Epub 2023 Mar 16.

  PMID: 36878873 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Aynur Aytekin Özdemir, PhD

  Istanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Stratified and block randomization method will be used in the randomization scheme of the study. In the study, maternal age, number of pregnancies, duration of intensive care unit stay and gestational age variables will be used in the stratification of newborns.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: control group (routine care) and experimental group (mandala painting)

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 22, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: September through November of 2025
• Access Criteria: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data

Locations

TU (1)