PreeclampsiaNCT06925841
Psychosocial Effects of Coloring in Preeclamptic Pregnant Women
A study testing Experimental and routine care in people with Preeclampsia and Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Anxiety, Pregnancy
- What is being tested?
- Experimental and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a single and healthy fetus
- Gestational age ≥ 20 weeks
- Diagnosed with preeclampsia by a physician
- Not having a history of treated pregnancy
Who cannot join
- Using psychiatric medication (self-report)
- Receiving psychological counseling during the intervention
- Diagnosed with severe preeclampsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Experimental, routine care
- Keywords
- preeclampsia, anxiety, pregnancy, mandala, stress, cortisol
- Medical subject headings
- Pre-Eclampsia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
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 careOther
The control group will receive routine care provided by the nurse.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Experimental |
| Routine care | Active comparator | The patients in the control group will receive only routine care and treatment. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: nine months
Secondary outcomes (2)
Psychosocial health
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.
Measured: nine months
Cortisol
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.
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start29 Mar 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with intervention group and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Kıyak, Necmettin Erbakan University
- Investigators
- Kamile Altuntuğ, Professor, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925841
- Sponsor's protocol ID
- 2023/425:14022
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mother-Baby Themed Coloring on Stress, Anxiety, and Psychosocial Health in Pregnant Women Diagnosed With Preeclampsia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06925841
- Acronym / sponsor ID
- 2023/425:14022
- Conditions
- Preeclampsia, Anxiety, Pregnancy, Stress
- Keywords
- preeclampsia, anxiety, pregnancy, mandala, stress, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Mother and Baby Themed Coloring Activity | Experimental | Other: ExperimentalParticipants 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. |
| Routine care | Active comparator | Other: routine careThe patients in the control group will receive only routine care and treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a single and healthy fetus
- Gestational age ≥ 20 weeks
- Diagnosed with preeclampsia by a physician
- Not having a history of treated pregnancy
Key exclusion criteria (3 listed)
- Using psychiatric medication (self-report)
- Receiving psychological counseling during the intervention
- Diagnosed with severe preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalTwo 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. | Other | Mother and Baby Themed Coloring Activity |
| routine careThe control group will receive routine care provided by the nurse. | Other | Routine care |
Primary outcome
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.
2 secondary outcomes
Psychosocial health
Time frame: nine months
Cortisol
Time frame: nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Active, not recruitingObservational study
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamile Altuntuğ, Professor study director
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and routine care in people with Preeclampsia and Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.