AnxietyNCT06499259
The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in NICU
A study testing Mandala coloring in people with Anxiety and Parents, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Parents, Psychological Stress
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2024to 31 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers whose baby has been in the neonatal intensive care unit for at least 3 days and staying in the mother's hotel,
- Having agreed to participate in the research/approved the informed consent form
- No visual or hearing impairment
- Being over 18 years old,
- Being at least literate
- The absence of any problem that would prevent him/her from painting mandala (no problem in his arm or hand that would prevent his movement)
- Must not have a diagnosis of mental illness/anxiety disorder
Who cannot join
- Mothers with communication and perception problems will not be included in the study.
- Mothers with comprehension and speech problems will not be included in the study.
- Mothers with psychiatric illness and taking medication will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, Kadıköy, 34720
About this study
Official title: The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in the Neonatal Intensive Care Unit: A Randomized Controlled Study
The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU).
Read the detailed description
The health status of the baby and the duration of stay in the intensive care unit cause the mother to experience varying levels of stress and anxiety. It is very important to determine the levels of stress and anxiety in mothers of newborns hospitalized in the Neonatal Intensive Care Unit and to take interventions to reduce it. This study will be conducted to evaluate the effect of mandala coloring activity on stress and anxiety levels in mothers whose babies are hospitalized in the neonatal intensive care unit. It is thought to make an important contribution to the field because it will be a randomized controlled study on the effect of mandala painting activity on stress and anxiety in mothers whose babies are hospitalized in the neonatal intensive care unit.
Type of study: The study was planned as a randomized controlled experimental study.
In the G*Power program, it was determined that it would be sufficient to include 30 participants in the study groups with a 5% alpha margin of error, 0.95 confidence interval, 0.95 effect size and 0.95 power. Considering the randomization list and possible losses, the sample size was increased by 20% and it was decided to include 72 mothers in the study, each group consisting of 36 participants.
Data Collection: Before starting the study, the purpose of the study will be explained to the participant by the researcher and informed consent will be obtained. Data collection tools will be applied to the mothers in the experimental group and the mandala painting activity will begin. The mandala painting program will consist of a total of 7 mandala painting sessions with 40-minute sessions every day for 7 days. The researcher will accompany the first mandala painting activity. She will answer the participant's questions. The mother will do the remaining 6 mandala coloring sessions alone every day; at the end of the 6 days, the researcher will reapply the data collection tools. The mothers in the control group will not receive any treatment within the scope of the study. When they are included in the study, data collection forms will be applied as the first measurement; at the end of 7 days, the same mothers will fill out the data collection forms again as the last measurement. After the completion of the data collection forms, the mothers in the control group will be given a mandala package consisting of 7 applications.
H0: Mandala coloring activity has no effect on stress and anxiety in mothers whose infants are hospitalized in the neonatal intensive care unit.
H1: Mandala coloring activity has a positive effect on stress and anxiety in mothers whose babies are hospitalized in the neonatal intensive care unit.
- Conditions
- Anxiety, Parents, Psychological Stress
- Being tested
- Mandala coloring
- Keywords
- Anxiety, Stress, Neonatal Intensive Care Unit, Mandala coloring, Mothers
- Medical subject headings
- Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloringOther
Mandala Pack and Application: The mandala pack is a pack consisting of 7 different patterns suitable for adults and 12 pencils. Mandala patterns will be photocopied by the researcher. Packages will be given to the mothers about mandala coloring and their questions will be answered. The choice of the color of the paint to be used in mandala coloring will be entirely up to the mother. No guidance will be given in this regard.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Data collection tools will be applied to the mothers in the experimental group and the mandala painting activity will begin. The mandala painting program will consist of a total of 7 mandala painting sessions with 40-minute sessions every day for 7 days. The researcher will accompany the first mandala painting activity. She will answer the participant's questions. The mother will do the remaining 6 mandala coloring sessions alone every day; at the end of the 6 days, the researcher will reapply the data collection tools. Receives: Other: Mandala coloring |
| Control group | No intervention | No application will be made to the mothers in the control group within the scope of the research. Data collection forms will be applied as the first measurement when they are included in the study; at the end of 7 days, the same mothers will fill out the data collection forms again as the last measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.
Measured: Before the first mandala painting session (pre-test)
Visual Analog Scale (VAS)
Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.
Measured: After the 7th mandala painting session (7 days after the first session) (post-test)
Secondary outcomes (2)
State Trait Anxiety Inventory (STAI)
The STAI (STAI-State Trait Anxiety Inventory) Scale consist of 20 items each and State Anxiety Scale was used in this study. The State Anxiety Scale has a rating scale consisting of (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree to which the person feels the current situation. Ten items (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) are reverse scored. The cronbach's alpha coefficient of the scale was 0.94 0.96.
Measured: Before the first mandala painting session (pre-test)
State Trait Anxiety Inventory (STAI)
The STAI (STAI-State Trait Anxiety Inventory) Scale consist of 20 items each and State Anxiety Scale was used in this study. The State Anxiety Scale has a rating scale consisting of (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree to which the person feels the current situation. Ten items (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) are reverse scored. The cronbach's alpha coefficient of the scale was 0.94 0.96.
Measured: After the 7th mandala painting session (7 days after the first session) (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start22 Jul 2024
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control group (routine care) and experimental group (mandala painting)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Aytekin Ozdemir, Istanbul Medeniyet University
- Investigators
- Aynur Aytekin Özdemir, PhD, Study director, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499259
- Sponsor's protocol ID
- 2024/411
- Status last verified
- Nov 2025
- First submitted
- 5 Jul 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
Publications
Sari Ozturk C, Demir K. The Effect of Mandala Activity and Technology-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Mother-Infant Attachment of Primiparous Women: A Randomized Controlled Study. J Med Syst. 2023 Apr 1;47(1):44. doi: 10.1007/s10916-023-01942-3.
PubMed 37004692Robinson EM, Baker R, Hossain MM. Randomized Trial Evaluating the Effectiveness of Coloring on Decreasing Anxiety Among Parents in a Pediatric Surgical Waiting Area. J Pediatr Nurs. 2018 Jul-Aug;41:80-83. doi: 10.1016/j.pedn.2018.02.001. Epub 2018 Feb 10.
PubMed 29439840Ozsavran M, Ayyildiz TK. The effect of mandala art therapy on the comfort and resilience levels of mothers who have children with special needs: A randomized controlled study. Child Care Health Dev. 2023 Nov;49(6):1032-1045. doi: 10.1111/cch.13110. Epub 2023 Mar 16.
PubMed 36878873
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in the Neonatal Intensive Care Unit: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06499259
- Acronym / sponsor ID
- 2024/411
- Conditions
- Anxiety, Parents, Psychological Stress
- Keywords
- Anxiety, Stress, Neonatal Intensive Care Unit, Mandala coloring, Mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Jul 2024 (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.
The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU).
Detailed description
The health status of the baby and the duration of stay in the intensive care unit cause the mother to experience varying levels of stress and anxiety. It is very important to determine the levels of stress and anxiety in mothers of newborns hospitalized in the Neonatal Intensive Care Unit and to take interventions to reduce it. This study will be conducted to evaluate the effect of mandala coloring activity on stress and anxiety levels in mothers whose babies are hospitalized in the neonatal intensive care unit. It is thought to make an important contribution to the field because it will be a randomized controlled study on the effect of mandala painting activity on stress and anxiety in mothers whose babies are hospitalized in the neonatal intensive care unit.
Type of study: The study was planned as a randomized controlled experimental study.
In the G*Power program, it was determined that it would be sufficient to include 30 participants in the study groups with a 5% alpha margin of error, 0.95 confidence interval, 0.95 effect size and 0.95 power. Considering the randomization list and possible losses, the sample size was increased by 20% and it was decided to include 72 mothers in the study, each group consisting of 36 participants.
Data Collection: Before starting the study, the purpose of the study will be explained to the participant by the researcher and informed consent will be obtained. Data collection tools will be applied to the mothers in the experimental group and the mandala painting activity will begin. The mandala painting program will consist of a total of 7 mandala painting sessions with 40-minute sessions every day for 7 days. The researcher will accompany the first mandala painting activity. She will answer the participant's questions. The mother will do the remaining 6 mandala coloring sessions alone every day; at the end of the 6 days, the researcher will reapply the data collection tools. The mothers in the control group will not receive any treatment within the scope of the study. When they are included in the study, data collection forms will be applied as the first measurement; at the end of 7 days, the same mothers will fill out the data collection forms again as the last measurement. After the completion of the data collection forms, the mothers in the control group will be given a mandala package consisting of 7 applications.
H0: Mandala coloring activity has no effect on stress and anxiety in mothers whose infants are hospitalized in the neonatal intensive care unit.
H1: Mandala coloring activity has a positive effect on stress and anxiety in mothers whose babies are hospitalized in the neonatal intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- control group (routine care) and experimental group (mandala painting)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Mandala coloringData collection tools will be applied to the mothers in the experimental group and the mandala painting activity will begin. The mandala painting program will consist of a total of 7 mandala painting sessions with 40-minute sessions every day for 7 days. The researcher will accompany the first mandala painting activity. She will answer the participant's questions. The mother will do the remaining 6 mandala coloring sessions alone every day; at the end of the 6 days, the researcher will reapply the data collection tools. |
| Control group | No intervention | –No application will be made to the mothers in the control group within the scope of the research. Data collection forms will be applied as the first measurement when they are included in the study; at the end of 7 days, the same mothers will fill out the data collection forms again as the last measurement. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Mothers whose baby has been in the neonatal intensive care unit for at least 3 days and staying in the mother's hotel,
- Having agreed to participate in the research/approved the informed consent form
- No visual or hearing impairment
- Being over 18 years old,
- Being at least literate
Key exclusion criteria (3 listed)
- Mothers with communication and perception problems will not be included in the study.
- Mothers with comprehension and speech problems will not be included in the study.
- Mothers with psychiatric illness and taking medication will not be included in the study.
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 |
|---|---|---|
| Mandala coloringMandala Pack and Application: The mandala pack is a pack consisting of 7 different patterns suitable for adults and 12 pencils. Mandala patterns will be photocopied by the researcher. Packages will be given to the mothers about mandala coloring and their questions will be answered. The choice of the color of the paint to be used in mandala coloring will be entirely up to the mother. No guidance will be given in this regard. | Other | Intervention group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Before the first mandala painting session (pre-test)
Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.
Visual Analog Scale (VAS)
Time frame: After the 7th mandala painting session (7 days after the first session) (post-test)
Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.
2 secondary outcomes
State Trait Anxiety Inventory (STAI)
Time frame: Before the first mandala painting session (pre-test)
State Trait Anxiety Inventory (STAI)
Time frame: After the 7th mandala painting session (7 days after the first session) (post-test)
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 24 Nov 2025.
- Background: PubMed 37004692Sari Ozturk C, Demir K. The Effect of Mandala Activity and Technology-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Mother-Infant Attachment of Primiparous Women: A Randomized Controlled Study. J Med Syst. 2023 Apr 1;47(1):44. doi: 10.1007/s10916-023-01942-3.
- Background: PubMed 29439840Robinson EM, Baker R, Hossain MM. Randomized Trial Evaluating the Effectiveness of Coloring on Decreasing Anxiety Among Parents in a Pediatric Surgical Waiting Area. J Pediatr Nurs. 2018 Jul-Aug;41:80-83. doi: 10.1016/j.pedn.2018.02.001. Epub 2018 Feb 10.
- Background: PubMed 36878873Ozsavran M, Ayyildiz TK. The effect of mandala art therapy on the comfort and resilience levels of mothers who have children with special needs: A randomized controlled study. Child Care Health Dev. 2023 Nov;49(6):1032-1045. doi: 10.1111/cch.13110. Epub 2023 Mar 16.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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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.
Aynur Aytekin Özdemir, PhD study director
Istanbul Medeniyet 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 Mandala coloring in people with Anxiety and Parents, run by Istanbul Medeniyet 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 7 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 24 Nov 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?
Visual Analog Scale (VAS) (time frame: Before the first mandala painting session (pre-test)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499259, which also lists 3 linked publications.
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 24 Nov 2025.