NCT07348900

Brief Summary

This single-group pretest-posttest study evaluated changes in anxiety levels among children undergoing inpatient chemotherapy and their parents following nurse-led recreational play activities. Thirty-one child-parent pairs completed the study. Child anxiety was assessed using the Children's State Anxiety Scale, and parent anxiety was assessed using the State Anxiety Inventory Form-I immediately before and immediately after the recreational play intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

January 9, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

Pediatric OncologyChemotherapyPlay-based InterventionParentsAnxiety

Outcome Measures

Primary Outcomes (1)

  • Change in Children's State Anxiety Scale Score

    The Children's State Anxiety Scale is a single-item visual scale used to assess children's state anxiety. Scores range from 0 to 10, with higher scores indicating greater state anxiety. Change was evaluated by comparing the scores obtained immediately before and immediately after the recreational play intervention.

    Immediately before and immediately after the recreational play intervention, within the same session

Secondary Outcomes (1)

  • Change in Parent State Anxiety Inventory Form-I Score

    Immediately before and immediately after the recreational play intervention, within the same session

Study Arms (1)

Nurse-Led Recreational Play Intervention

EXPERIMENTAL

Children and their parents received structured play-based supportive care activities in addition to routine chemotherapy care.

Behavioral: Nurse-Led Recreational Play Activities

Interventions

Children undergoing inpatient chemotherapy participated with one parent in nurse-led recreational play activities conducted in the clinic playroom after scheduled treatment. The available activities included puzzles, Lego and model-building games, puppet-making and puppet play, storytelling, drawing, origami, and mandala coloring. Children selected activities according to their preferences, age, clinical condition, and attention span. Parents were encouraged to participate when appropriate. The recreational play activities lasted approximately 30-60 minutes. Child and parent anxiety levels were assessed immediately before and immediately after the intervention.

Nurse-Led Recreational Play Intervention

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-10 years who were hospitalized for chemotherapy treatment in the pediatric oncology and hematology clinic Willingness of both the child and parent to participate Written informed consent provided by the parent Parent able to read and write Turkish

You may not qualify if:

  • A major stressful life event unrelated to the illness during the previous six months, such as parental divorce, relocation, or death of a family member A clinically unstable condition preventing participation in recreational activities Terminal-stage disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Hospital, Pediatric Oncology and Hematology Clinic

Antalya, 7090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Şule Şenol, PhD

    Akdeniz Üniversitesi Hemşirelik Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This quasi-experimental study used a single-group pretest-posttest design. Participants received structured play-based supportive care activities in addition to routine care, and outcomes were assessed before and after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

November 15, 2024

Primary Completion

May 7, 2025

Study Completion

May 7, 2025

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the inclusion of pediatric participants and the absence of specific consent for data sharing.

Locations