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

Not Applicable

Completed

• Conditions: Anxiety During Pregnancy; Mental Fatigue; Mandala
• Interventions: Other: mandala painting

• Registration Number: NCT06589648
• Lead Sponsor: KTO Karatay University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2024-09-04
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Completion: 2025-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	mandala painting	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.

Primary Outcome Measures

Name	Time	Method
Pregnancy-Related Anxiety Scale	0-3 day	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

Secondary Outcome Measures

Name	Time	Method
State Anxiety Inventory	0-3 day	It is a scale consisting of 20 questions developed by Speilberger et al. (1983) (Öner, 1997; Öner \& Le Compte, 1985). It was adapted to Turkish by Öner and Le Compte (1974-1977) (Öner, 1997; Öner \& Le Compte, 1985). The emotions or behaviors expressed in the items of the scale consist of the following options according to the severity of the experience: 1) Not at all, 2) A little, 3) A lot, and 4) Completely. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 of the scale are reverse-coded. The total score obtained from the scale varies between 20 and 80 (Öner, 1997; Öner \& Le Compte, 1985). A high score indicates a high level of anxiety, a low score indicates a low level of anxiety.

Trial Locations

Locations (1)

Necmettin Erbakan University Medical Faculty Hospital; 🇹🇷 Konya, Konya/ Selçuklu, Turkey