Psychosocial Effects of Coloring in Preeclamptic Pregnant Women

Not Applicable

Completed

• Conditions: Preeclampsia; Anxiety; Pregnancy; Stress

• Registration Number: NCT06925841
• Lead Sponsor: Necmettin Erbakan University

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-29
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety	nine months	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.

Secondary Outcome Measures

Name	Time	Method
Psychosocial health	nine months	The Pregnancy Psychosocial Health Assessment Scale was used to evaluate psychosocial health during pregnancy. It consists of 46 items and has six subscales (characteristics related to pregnancy and partner relationship, characteristics related to anxiety and stress, characteristics related to domestic violence, characteristics related to psychosocial support needs, family characteristics, and characteristics related to physical-psychosocial changes in pregnancy). The total score obtained from the scale is divided by the number of items to determine the average value, resulting in a score between 1 and 5. The closer the total score is to 1, the greater the problem in psychosocial health during pregnancy, and a score of 1 indicates very poor psychosocial health. The same evaluation applies to the subscales, and the closer the score is to 1, the more likely there is a problem with that specific factor.
Cortisol	nine months	Cortisol measurement will be conducted on Day 1 (pre-test) and Day 3 (post-test). To determine cortisol levels, blood samples will be collected from participants in both the intervention and control groups between 08:00 and 10:00 in the morning. Blood samples will be taken by nurses working in the clinic. Typically, the blood volume collected from each participant is 3-4 ml. The collected blood samples will be analyzed in the Biochemistry Laboratory of the Faculty of Medicine using the Electrochemiluminescence Immunoassay (ECLIA) method. Blood samples from both the intervention and control groups will be centrifuged at 4000 rpm for 10 minutes. Serum cortisol samples will be measured using the Cobas cortisol kit (Roche Diagnostics, USA) with the fully automated Roche Elecsys 8000 (Hitachi; Roche Diagnostics, Germany) device according to the ECLIA method.

Trial Locations

Locations (1)

Necmettin Erbakan University; 🇹🇷 Konya, Turkey