- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348900
Effect of Recreational Play Activities on Anxiety in Children Receiving Chemotherapy and Their Parents
The Effect of Recreational Play Activities on Anxiety Levels of Children Undergoing Chemotherapy and Their Parents: A Quasi-Experimental Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aimed to examine the effect of recreational play activities on anxiety levels of children undergoing chemotherapy and their parents. A quasi-experimental study design was used. The study was conducted in a pediatric oncology unit and included children receiving chemotherapy and their parents who met the inclusion criteria.
Participants were assigned to an intervention group that received structured recreational play activities in addition to routine care. Recreational play activities were planned according to the age and developmental level of the children and were implemented during chemotherapy sessions. The activities included age-appropriate games and play-based interactions designed to promote relaxation, emotional expression, and coping.
Anxiety levels of children and parents were assessed before and after the intervention using validated anxiety measurement scales. Demographic and clinical data were also collected. The primary outcome of the study was the change in anxiety levels of children and parents following participation in recreational play activities.
Ethical approval was obtained from the relevant Clinical Research Ethics Committee prior to the initiation of the study. Written informed consent was obtained from parents, and assent was obtained from children when appropriate. All study procedures were conducted in accordance with ethical principles and institutional guidelines.
The results of this study provide evidence on the effectiveness of recreational play activities as a non-pharmacological nursing intervention to reduce anxiety in pediatric oncology settings and support the integration of play-based approaches into routine clinical care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey (Türkiye), 7090
- Akdeniz University Hospital, Pediatric Oncology and Hematology Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Play-Based Intervention Group
Children and their parents received structured play-based supportive care activities in addition to routine chemotherapy care.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety level of children undergoing chemotherapy
Time Frame: Baseline (before the intervention) and immediately after the intervention during the chemotherapy session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental anxiety level
Time Frame: Baseline (before the intervention) and immediately after the intervention during the chemotherapy session
|
Parental anxiety was assessed using the State Anxiety Inventory (STAI-I), a validated self-report questionnaire consisting of 20 items with total scores ranging from 20 to 80, where higher scores indicate higher levels of anxiety.
|
Baseline (before the intervention) and immediately after the intervention during the chemotherapy session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Şule Şenol, PhD, Akdeniz Üniversitesi Hemşirelik Fakültesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 241 (University Clinical Research Ethics Committee (Turkey))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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