NCT07845123

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Nov 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

MandalaHospitalizationAnxietyNurseNursing Image

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).

Study Arms (2)

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.

Other: Mandala Coloring

Interventions

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.

Experimental Group

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilis Prof. Dr. Alaeddin Yavaşca State Hospital, Kilis, Central

Kilis, Central, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Gamze AKAY, 1

    Artvin Coruh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations