NCT07348900

Brief Summary

Children receiving chemotherapy often experience high levels of anxiety, which may also affect their parents. Anxiety during treatment can negatively influence emotional well-being, treatment adherence, and overall quality of life. Non-pharmacological and supportive interventions, such as recreational play activities, may help reduce anxiety in pediatric patients and their caregivers. The aim of this study is to evaluate the effect of recreational play activities on anxiety levels of children undergoing chemotherapy and their parents. The study was conducted using a quasi-experimental design in a pediatric oncology setting. Children receiving chemotherapy and their parents participated in structured recreational play activities in addition to routine care. Anxiety levels of both children and parents were assessed before and after the intervention using validated anxiety assessment tools. The findings of this study are expected to contribute to evidence-based nursing practices by highlighting the potential benefits of recreational play activities as a supportive intervention to reduce anxiety in pediatric oncology patients and their parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

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

Click on a node to explore related trials.

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

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 9, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

Pediatric OncologyChemotherapyPlay-based InterventionParentsAnxiety

Outcome Measures

Primary Outcomes (1)

  • Anxiety level of children undergoing chemotherapy

    Children's anxiety was assessed using the Child Anxiety Scale-State (CAS-State), an age-appropriate visual analog scale designed for children aged 4-10 years. The scale ranges from 0 to 10, where higher scores indicate higher levels of state anxiety. Anxiety scores were recorded at baseline (before the play-based recreational activity intervention) and immediately after the intervention during the chemotherapy session.

    Baseline (before the intervention) and immediately after the intervention during the chemotherapy session

Secondary Outcomes (1)

  • Parental anxiety level

    Baseline (before the intervention) and immediately after the intervention during the chemotherapy session

Study Arms (1)

Play-Based Intervention Group

EXPERIMENTAL

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

Behavioral: Play-Based Supportive Care Activities

Interventions

Structured play-based supportive care activities were provided to children during chemotherapy sessions to reduce anxiety and pain and to support emotional coping. Parents accompanied the children during the activities.

Play-Based Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Children aged 4-10 years receiving inpatient chemotherapy treatment in a pediatric oncology and hematology clinic;
  • Children and parents who agreed to participate in the study and provided written informed consent;
  • Children able to communicate verbally; parents who are able to read and write in Turkish.

You may not qualify if:

  • Children who experienced a significant life event unrelated to the disease within the last six months (such as parental divorce, death of a parent, or relocation);
  • Children receiving more than one chemotherapy cycle simultaneously;
  • Children in the terminal stage of the disease;
  • Children or parents who declined participation or withdrew before completion of the study.

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

January 20, 2026

Record last verified: 2026-01

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