- 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 Nurse-Led Recreational Play Activities on Anxiety Levels of Children Undergoing Chemotherapy and Their Parents: A Quasi-Experimental Study
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
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-
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Antalya, Turkey (Türkiye), 7090
- Akdeniz University Hospital, Pediatric Oncology and Hematology Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
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 |
|---|---|
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Experimental: Nurse-Led Recreational Play Intervention
Children and their parents received structured play-based supportive care activities in addition to routine chemotherapy care.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Children's State Anxiety Scale Score
Time Frame: Immediately before and immediately after the recreational play intervention, within the same session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Parent State Anxiety Inventory Form-I Score
Time Frame: Immediately before and immediately after the recreational play intervention, within the same session
|
The State Anxiety Inventory Form-I is a 20-item instrument used to assess parents' situational anxiety.
Total scores range from 20 to 80, 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
|
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 (Actual)
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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