Psychosocial Effects of Coloring in Preeclamptic Pregnant Women

April 7, 2025 updated by: Sibel Kıyak, Necmettin Erbakan University

The Effect of Mother-Baby Themed Coloring on Stress, Anxiety, and Psychosocial Health in Pregnant Women Diagnosed With Preeclampsia: A Randomized Controlled Trial

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Necmettin Erbakan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.
Active Comparator: Routine care
The patients in the control group will receive only routine care and treatment.
Other: routine care
The control group will receive routine care provided by the nurse.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 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.
nine months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychosocial health
Time Frame: 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.
nine months
Cortisol
Time Frame: 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.
nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Necmettin Erbakan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
necmettin erbakan university Scientific Research Projects (BAP)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kamile Altuntuğ, Professor, Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/425:14022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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