The Effect of Mandala Coloring on Anxiety and Mental Fatigue in Pregnant Women Diagnosed With Threatened Preterm Labor

NCT06589648 | Completed

• 1 other identifier: KTO- Midwifery- C.N.Bircan-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The research will be conducted in a pre-test-post-test control group randomized control design. The aim is to examine the effect of mandala work on anxiety and mental fatigue in pregnant women diagnosed with threatened preterm labor. Hypotheses

1. 1.Mandala coloring work reduces the level of anxiety related to pregnancy in pregnant women diagnosed with threatened preterm labor.
2. 2.Mandala coloring work reduces the level of anxiety in pregnant women diagnosed with threatened preterm labor.
3. 3.Mandala coloring work reduces the level of mental fatigue in pregnant women diagnosed with threatened preterm labor.

Conditions

Anxiety During Pregnancy; Mental Fatigue; Mandala

Outcome Measures

Primary Outcomes (1)

• Pregnancy-Related Anxiety Scale

  It was developed by Brunton et al. (2019), which can be applied to primiparous and multiparous pregnant women, and adapted into Turkish by Şolt and Kanza Gül (2020). The scale is a 4-point Likert-type scale with 9 sub-dimensions: "Birth-Related Anxiety" (items 1, 2, 3, 4, 5, and 6), "Body Image Anxiety" (items 7, 8, 9, 10, and 11), "Attitudes Towards Birth" (items 12, 13, 14), "Concerns About Motherhood" (items 15, 16, 17), "Acceptance of Pregnancy" (items 18, 19, 20), "Anxiety Indicators" (items 21, 22, 23, and 24), "Attitudes Towards Healthcare Personnel" (items 25, 26, and 27), "Avoidance" (items 28, 29, and 30) and "Attitudes Towards the Baby" (items 29, 30, and 40). It consists of a total of 33 items, including "Anxiety" (items 31, 32 and 33). The lowest score is 33 and the highest is 132, and there is no cut-off point. As the scores obtained from the scale increase, anxiety related to pregnancy increases. The Cronbach Alpha coefficient of the scale was stated as 0.82 for multipa

  0-3 day

Secondary Outcomes (1)

• State Anxiety Inventory

  0-3 day

Other Outcomes (1)

• Mental Fatigue Scale

  0-3 day

Study Arms (2)

intervention group

EXPERIMENTAL

Participants in the intervention group will be given a set of colored markers and a mandala coloring page and will be asked to color them any time of the day and in any way they want during their hospital stay. Participants will be asked to take a picture of the mandala they colored and send it to the researcher after they are finished. Participants will be reminded daily so that they do not forget to do the activity.

Other: mandala painting

control group

NO INTERVENTION

No intervention other than routine care will be made to the control group of the study, and research data will be collected at simultaneous intervals with the experimental group.

Interventions

mandala painting OTHER

Mandala coloring creates a relaxing effect on individuals because it starts with a pattern that develops like a flower around a point; it allows the individual to stay in the moment, to get away from stress, anxiety and worries, and it relaxes the mind.

intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who can read and write Turkish,
• Diagnosed with threatened preterm labor,
• Are between 32-36 weeks of gestation,
• Primiparous,
• Hospitalized,
• Open to communication (able to understand and answer questions) will be included in the sample.

You may not qualify if:

• Pregnant women with a history of miscarriage or stillbirth,
• Those who voluntarily withdrew from the study,
• Those with a history of psychiatric illness (self-report),
• Those who do not have a physical disability that would prevent them from coloring mandalas will be excluded from the study.

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Necmettin Erbakan University Medical Faculty Hospital

Konya, Konya/ Selçuklu, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Karakoç

  KTO Karatay Univeristy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research statistician will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Researcher

Model Details: mandala coloring

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: September 4, 2024
• Study Completion: April 10, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)