AnxietyNCT07348900
Effect of Recreational Play Activities on Anxiety in Children Receiving Chemotherapy and Their Parents
A study testing Nurse-Led Recreational Play Activities in people with Anxiety and Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- What is being tested?
- Nurse-Led Recreational Play Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 7 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Hospital, Pediatric Oncology and Hematology Clinic
Antalya, 7090
About this study
Official title: The Effect of Nurse-Led Recreational Play Activities on Anxiety Levels of Children Undergoing Chemotherapy and Their Parents: A Quasi-Experimental Study
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.
Read the 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.
- Being tested
- Nurse-Led Recreational Play Activities
- Keywords
- Pediatric Oncology, Chemotherapy, Play-based Intervention, Parents, Anxiety
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Recreational Play ActivitiesBehavioural
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. Each child participated in the recreational play activities together with one parent. Parental participation was a standardized component of the intervention, and the parent actively engaged in the activity or activities selected by the child. The recreational play activities lasted approximately 30-60 minutes. Child and parent anxiety levels were assessed immediately before and immediately after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Recreational Play Intervention | Experimental | Children and their parents received structured play-based supportive care activities in addition to routine chemotherapy care. Receives: Behavioral: Nurse-Led Recreational Play Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Immediately before and immediately after the recreational play intervention, within the same session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Nov 2024
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule ŞENOL, Akdeniz University
- Investigators
- Şule Şenol, PhD, Principal investigator, Akdeniz Üniversitesi Hemşirelik Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348900
- Sponsor's protocol ID
- 241
- Other IDs
- 241
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the inclusion of pediatric participants and the absence of specific consent for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Led Recreational Play Activities on Anxiety Levels of Children Undergoing Chemotherapy and Their Parents: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07348900
- Acronym / sponsor ID
- 241
- Keywords
- Pediatric Oncology, Chemotherapy, Play-based Intervention, Parents, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Recreational Play Intervention | Experimental | Behavioral: Nurse-Led Recreational Play ActivitiesChildren and their parents received structured play-based supportive care activities in addition to routine chemotherapy care. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Recreational Play ActivitiesChildren 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. Each child participated in the recreational play activities together with one parent. Parental participation was a standardized component of the intervention, and the parent actively engaged in the activity or activities selected by the child. The recreational play activities lasted approximately 30-60 minutes. Child and parent anxiety levels were assessed immediately before and immediately after the intervention. | Behavioural | Nurse-Led Recreational Play Intervention |
Primary outcome
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.
1 secondary outcome
Change in Parent State Anxiety Inventory Form-I Score
Time frame: Immediately before and immediately after the recreational play intervention, within the same session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the inclusion of pediatric participants and the absence of specific consent for data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şule Şenol, PhD principal investigator
Akdeniz Üniversitesi Hemşirelik Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Recreational Play Activities in people with Anxiety and Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Children's State Anxiety Scale Score (time frame: Immediately before and immediately after the recreational play intervention, within the same session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.