Psychosocial Effects of Coloring in Preeclamptic Pregnant Women

NCT ID: NCT06925841

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-29
• Study Completion Date: 2024-12-15

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

Study Design

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

Study Groups

Mother and Baby Themed Coloring Activity

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.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: 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.

Routine care

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

Group Type: ACTIVE_COMPARATOR

routine care

Intervention Type: OTHER

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

Interventions

Experimental

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.

Intervention Type: OTHER

routine care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

necmettin erbakan university Scientific Research Projects (BAP)

UNKNOWN

Sponsor Role: collaborator

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Sibel Kıyak

Assist. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamile Altuntuğ, Professor

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

Necmettin Erbakan University

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/425:14022

Identifier Type: -

Identifier Source: org_study_id