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

NCT ID: NCT06589648

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-04-10

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

2. Mandala coloring work reduces the level of anxiety in pregnant women diagnosed with threatened preterm labor.

3. Mandala coloring work reduces the level of mental fatigue in pregnant women diagnosed with threatened preterm labor.

Pregnant women who meet the inclusion criteria will be given general information about the research before randomization, their consent will be obtained and pre-test data will be collected. Pregnant women whose pre-test data are collected will be assigned to the intervention and control groups using the simple randomization method.

Intervention group: 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 at any time of the day and in any way they want during their hospitalization. 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. Research data will be collected a total of four times before randomization, on the 1st day, 2nd day and 3rd day after the mandala application was started.

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

Conditions

Anxiety During Pregnancy; Mental Fatigue; Mandala

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

intervention group

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.

Group Type: EXPERIMENTAL

mandala painting

Intervention Type: 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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mandala painting

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

KTO Karatay University

OTHER

Sponsor Role: lead

Responsible Party

Cennet Nur Bircan

Chief Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karakoç

Role: STUDY_DIRECTOR

KTO Karatay Univeristy

Locations

Necmettin Erbakan University Medical Faculty Hospital

Konya, Konya/ Selçuklu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KTO- Midwifery- C.N.Bircan-001

Identifier Type: -

Identifier Source: org_study_id