Psychosocial Effects of Coloring in Preeclamptic Pregnant Women

NCT06925841 | Completed

• 1 other identifier: 2023/425:14022
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia is one of the major causes of maternal and neonatal mortality and morbidity, affecting approximately 3-5% of pregnancies. A diagnosis of preeclampsia may lead to psychological problems such as psychosocial distress, depression, and anxiety due to prolonged hospitalization, concerns about the future health of the baby, separation from family, and adapting to a foreign environment. Health professionals play a crucial role in the diagnosis, treatment, and care of high-risk pregnancies and also implement non-pharmacological supportive methods such as yoga, progressive muscle relaxation, and mindfulness. One of these non-pharmacological methods is mandala. According to the literature, integrating mandala coloring into perinatal care is believed to have beneficial effects. Therefore, the primary aim of this study is to investigate the effects of mother-baby themed coloring on anxiety. The secondary aim is to determine its effects on psychosocial health and cortisol levels. H1a: Is there a difference between anxiety scores in preeclamptic pregnant women who were and were not exposed to dyeing activity? H1b: Is there a difference between psychosocial health scores in preeclamptic pregnant women who were and were not exposed to dyeing activity? H1c: Is there a difference between cortisol levels in preeclamptic pregnant women who were and were not exposed to dyeing activity?

Conditions

Preeclampsia; Anxiety; Pregnancy; Stress

Keywords

preeclampsia; anxiety; pregnancy; mandala; stress; cortisol

Outcome Measures

Primary Outcomes (1)

• Anxiety

  The State-Trait Anxiety Inventory was used to determine the anxiety level. The scale consists of a total of 40 items, with 20 items for state anxiety and 20 items for trait anxiety. In this study, the state anxiety section of the scale will be used. The scale is a four-point Likert-type, with items scored between 1 and 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = completely). The score range for each subscale is between 20 and 80 points. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20, 21, 26, 27, 30, 33, 36, and 39 are positively worded and do not express anxiety. Therefore, these items are reverse coded during the analysis phase. As the score obtained from the scale increases, the level of anxiety also increases.

  nine months

Secondary Outcomes (2)

• Psychosocial health

  nine months

• Cortisol

  nine months

Study Arms (2)

Mother and Baby Themed Coloring Activity

EXPERIMENTAL

Participants in this intervention group will color mother-and-baby-themed images provided by the researcher using a free coloring technique. In addition to routine care, each pregnant woman will participate in a structured 30-minute coloring activity each day.

Other: Experimental

Routine care

ACTIVE COMPARATOR

The patients in the control group will receive only routine care and treatment.

Other: routine care

Interventions

Experimental OTHER

Two pre-selected mother-baby themed images to be used in the study will be printed separately on A4-sized papers (21.0 cm × 29.7 cm). Each participant will receive a new image every day.At the beginning of the study, each participant will be provided with a set of 12 colored pencils (orange, red, pink, purple, light blue, dark blue, light green, dark green, light brown, dark brown, black, and white). Colored pencils have been preferred over soft-tipped pencils due to their requirement for greater physical effort and their ability to facilitate a clearer expression of emotions. Participants in the intervention group will receive routine care and will engage in a 30-minute daily coloring activity.

Mother and Baby Themed Coloring Activity

routine care OTHER

The control group will receive routine care provided by the nurse.

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a single and healthy fetus
• Gestational age ≥ 20 weeks
• Diagnosed with preeclampsia by a physician
• Not having a history of treated pregnancy

You may not qualify if:

• Using psychiatric medication (self-report)
• Receiving psychological counseling during the intervention
• Diagnosed with severe preeclampsia

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• necmettin erbakan university Scientific Research Projects (BAP): collaborator

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-Eclampsia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Study Officials

• Kamile Altuntuğ, Professor

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Professor

Model Details: Two groups with intervention group and control group

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: March 29, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)