Attitude to HealthNCT07845123
The Effect of a Mandala Coloring-Based Nursing Intervention on Perceived Nursing Image and Anxiety in Children Hospitalized in a Pediatric Clinic: A Randomized Controlled Trial
A study testing Mandala Coloring in people with Attitude to Health, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effect of a mandala coloring-based nursing intervention on perceived nursing image and state anxiety levels in children aged 8-11 years hospitalized in a pediatric clinic. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Attitude to Health
- What is being tested?
- Mandala Coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 8 and 11 years
- Hospitalized in the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital
- Expected hospitalization for at least three more days based on clinical evaluation and having no clinical impediment to completing the 3-day intervention protocol
- Able to read and write in Turkish with adequate cognitive ability to understand questions
- Willingness of both child and parent to participate, with written informed consent provided by the parent
- Being able to communicate at an adequate level
Who cannot join
- Inability to complete the 3-day intervention protocol due to early discharge or other reasons
- Deterioration of the child's clinical condition preventing continuation of the application
- Inability to complete data collection or outcome measurement procedures
- Request by the child or parent to withdraw from the study at any stage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kilis Prof. Dr. Alaeddin Yavaşca State Hospital, Kilis, Central
Kilis, Central
Elif Simay KOÇ, 2, +90 507 149 97 46, elifsimay.koc@kilis.edu.tr
About this study
The purpose of this study is to evaluate the effect of a mandala coloring-based nursing intervention on perceived nursing image and state anxiety levels in children aged 8-11 years hospitalized in a pediatric clinic.
Read the detailed description
The study will be conducted as a randomized controlled trial at the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital. A total of 64 children meeting the inclusion criteria will be randomly assigned to the intervention (n=32) and control (n=32) groups. Children in the intervention group will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days, while the control group will receive routine clinical care. Data will be collected using a Descriptive Information Form, the Children's Perceived Nursing Image Scale, and the State Anxiety Inventory for Children. State anxiety will be evaluated at baseline, on the third day, and before discharge, while perceived nursing image will be evaluated at baseline and before discharge.
- Conditions
- Attitude to Health
- Being tested
- Mandala Coloring
- Keywords
- Mandala, Hospitalization, Anxiety, Nurse, Nursing Image
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ColoringOther
Children in the intervention group will receive a mandala coloring-based nursing intervention conducted by the researcher for 20 minutes once daily over three consecutive days. The session will take place in the patient's room or a quiet area within the pediatric clinic at a time that does not interfere with routine care. Each child will be provided with an individual mandala coloring book and a set of 12 colored pencils. Prior to the session, brief communication will be established to explain the activity, allowing the child full autonomy over color selection and coloring style without interference. Communication from the researcher will remain neutral, standardized, and age-appropriate. Children in the control group will receive routine clinical care only, with no mandala coloring or other distraction interventions applied.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Children will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days during hospitalization, and their anxiety and perceived nursing image will be evaluated. Receives: Other: Mandala Coloring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
The Introductory Information Form was prepared by the researchers based on the relevant literature. The form consists of a total of 10 questions designed to assess the sociodemographic characteristics of the children and their parents, as well as information regarding hospitalization. It includes questions concerning variables such as the child's age, gender, grade level, previous hospitalization experience, duration of stay, and reason for admission, as well as the parent's age, education level, employment status, and family type.
Measured: Baseline
State Anxiety Level
Assessed using the State Anxiety Inventory for Children (SAIC / STAIC). The scale consists of 20 items scored between 20 and 60, where higher scores indicate higher levels of state anxiety.
Measured: Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
Perceived Nursing Image
Assessed using the Children's Perceived Nursing Image Scale. The scale consists of 35 items scored between 35 and 175, where higher scores indicate a more positive perception of the nursing image.
Measured: Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attitude to HealthStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Akay, Artvin Coruh University
- Investigators
- Gamze AKAY, 1, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845123
- Sponsor's protocol ID
- Mandala Coloring in Children
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akay G, Guducu Tufekci F. Storytelling Intervention Relieved Pain During Tracheostomy Suction in Children Under Palliative Care: A Randomised Controlled Trial. Scand J Caring Sci. 2026 Mar;40(1):e70182. doi: 10.1111/scs.70182.
PubMed 41588469
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Mandala Coloring-Based Nursing Intervention on Perceived Nursing Image and Anxiety in Children Hospitalized in a Pediatric Clinic: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07845123
- Acronym / sponsor ID
- Mandala Coloring in Children
- Conditions
- Attitude to Health
- Keywords
- Mandala, Hospitalization, Anxiety, Nurse, Nursing Image
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 28 Sep 2026 (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 purpose of this study is to evaluate the effect of a mandala coloring-based nursing intervention on perceived nursing image and state anxiety levels in children aged 8-11 years hospitalized in a pediatric clinic.
Detailed description
The study will be conducted as a randomized controlled trial at the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital. A total of 64 children meeting the inclusion criteria will be randomly assigned to the intervention (n=32) and control (n=32) groups. Children in the intervention group will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days, while the control group will receive routine clinical care. Data will be collected using a Descriptive Information Form, the Children's Perceived Nursing Image Scale, and the State Anxiety Inventory for Children. State anxiety will be evaluated at baseline, on the third day, and before discharge, while perceived nursing image will be evaluated at baseline and before discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Mandala ColoringChildren will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days during hospitalization, and their anxiety and perceived nursing image will be evaluated. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 8 and 11 years
- Hospitalized in the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital
- Expected hospitalization for at least three more days based on clinical evaluation and having no clinical impediment to completing the 3-day intervention protocol
- Able to read and write in Turkish with adequate cognitive ability to understand questions
- Willingness of both child and parent to participate, with written informed consent provided by the parent
Key exclusion criteria (4 listed)
- Inability to complete the 3-day intervention protocol due to early discharge or other reasons
- Deterioration of the child's clinical condition preventing continuation of the application
- Inability to complete data collection or outcome measurement procedures
- Request by the child or parent to withdraw from the study at any stage
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 ColoringChildren in the intervention group will receive a mandala coloring-based nursing intervention conducted by the researcher for 20 minutes once daily over three consecutive days. The session will take place in the patient's room or a quiet area within the pediatric clinic at a time that does not interfere with routine care. Each child will be provided with an individual mandala coloring book and a set of 12 colored pencils. Prior to the session, brief communication will be established to explain the activity, allowing the child full autonomy over color selection and coloring style without interference. Communication from the researcher will remain neutral, standardized, and age-appropriate. Children in the control group will receive routine clinical care only, with no mandala coloring or other distraction interventions applied. | Other | Experimental Group |
Primary outcome
Introductory Information Form
Time frame: Baseline
The Introductory Information Form was prepared by the researchers based on the relevant literature. The form consists of a total of 10 questions designed to assess the sociodemographic characteristics of the children and their parents, as well as information regarding hospitalization. It includes questions concerning variables such as the child's age, gender, grade level, previous hospitalization experience, duration of stay, and reason for admission, as well as the parent's age, education level, employment status, and family type.
State Anxiety Level
Time frame: Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
Assessed using the State Anxiety Inventory for Children (SAIC / STAIC). The scale consists of 20 items scored between 20 and 60, where higher scores indicate higher levels of state anxiety.
Perceived Nursing Image
Time frame: Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
Assessed using the Children's Perceived Nursing Image Scale. The scale consists of 35 items scored between 35 and 175, where higher scores indicate a more positive perception of the nursing image.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Results publication: PubMed 41588469Akay G, Guducu Tufekci F. Storytelling Intervention Relieved Pain During Tracheostomy Suction in Children Under Palliative Care: A Randomised Controlled Trial. Scand J Caring Sci. 2026 Mar;40(1):e70182. doi: 10.1111/scs.70182.
- Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gamze AKAY, 1 principal investigator
Artvin Coruh 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 Attitude to Health, run by Artvin Coruh 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamze AKAY, 1 (05314536661, gamzeakay_25@artvin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: Baseline). The study lists 3 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 NCT07845123, which also lists 1 linked publication.
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 28 Sep 2026.