Pediatric NursingNCT07335458
Reducing Fear and Anxiety in Children Through Free Play
A study testing Child-Directed Free Play in people with Pediatric Nursing and Preoperative Anxiety, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of free-play activities on preoperative fear and state anxiety in children aged 5-10 years and on parental anxiety. The research was conducted as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Pediatric Nursing, Preoperative Anxiety, Parental Anxiety
- What is being tested?
- Child-Directed Free Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Feb 2026
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children:
- Aged 5-10 years
- Scheduled to undergo ambulatory or inpatient surgery
- No chronic or neurological disease
- No cognitive, hearing, or visual impairment that could interfere with communication or completion of the study instruments
- Willing to participate and able to provide verbal assent
Show all 10Show fewer
- Parents:
- Literate
- Accompanying the child during the preoperative period
- Willing to provide written informed consent
Who cannot join
- Previous psychiatric diagnosis
- Current use of anxiolytic or sedative medication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Osmaniye Korkut Ata University
Osmaniye, Osmaniye, 80010
About this study
Official title: Effects of Child-Directed Free Play on Preoperative Fear and Anxiety in Children and Parental Anxiety: A Randomized Controlled Trial
The aim of this study was to determine the effect of free-play activities on preoperative fear and state anxiety in children aged 5-10 years and on parental anxiety. The research was conducted as a randomized controlled trial. The study population consisted of children aged 5-10 years and their parents who underwent planned surgical procedures in the pediatric surgery ward of a training and research hospital. Eligible child-parent dyads were recruited using a convenience sampling method and were then randomly assigned to the intervention and control groups.
The data collection process in the study was conducted in two stages, with intervention and control groups: pretest and posttest. Tests for both groups were administered before the planned surgical procedure. A pretest for the children and their parents in the intervention group was administered approximately 2 hours before the surgical procedure, just before the start of the free-play intervention. At this stage, baseline data were obtained by measuring the children's fear and state anxiety levels and the parents' anxiety levels.
Read more
Following this, the children participated in approximately 40 minutes of child-directed free play. A posttest was administered immediately after the free-play intervention, approximately 20 minutes before surgery. This measurement was used to evaluate the effect of free play on the dependent variables.
In the control group, no study-related intervention was applied, and routine preoperative care continued. This group was also assessed with a pretest approximately 2 hours before surgery and a posttest after the corresponding 40-minute period, approximately 20 minutes before surgery, to evaluate the children's fear and state anxiety levels and parental anxiety. This allowed the differences between the two groups to be compared. This timing was selected to assess children's anxiety and fear during the period when preoperative distress was expected to be high and to evaluate the immediate effect of free play.
Study Population: The study population consisted of children aged 5-10 years who underwent elective surgical procedures and their parents.
Study Sample: The study included children aged 5-10 years who underwent surgical procedures and one accompanying parent for each child. The child-parent dyads were randomly assigned to the intervention and control groups.
An a priori power analysis was performed using G*Power version 3.1.9.7. Based on Cohen's d = 0.65, an α level of .05, statistical power of 80%, and a 1:1 allocation ratio, at least 39 child-parent dyads were required in each group. To account for potential attrition or missing data, 80 child-parent dyads were recruited, with 40 assigned to the intervention group and 40 assigned to the control group.
The hypotheses of the study were:
H1a: The posttest Children's Fear Scale scores of children in the free-play group are lower than their pretest scores.
H1b: Children in the free-play group have lower posttest Children's Fear Scale scores than children in the control group.
H2a: The posttest Children's Anxiety Meter-State scores of children in the free-play group are lower than their pretest scores.
H2b: Children in the free-play group have lower posttest Children's Anxiety Meter-State scores than children in the control group.
H3a: Parents in the free-play group have lower posttest anxiety scores than their pretest scores.
H3b: Parents in the free-play group have lower posttest anxiety scores than parents in the control group.
H4: There are positive associations among parental anxiety, children's state anxiety, and children's fear levels both before and after the intervention.
- Being tested
- Child-Directed Free Play
- Keywords
- Free play, Game-based intervention, Child-Directed Free Play, Pediatric Surgery, Family-Centered Care, Nonpharmacological Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child-Directed Free PlayBehavioural
A 40-minute child-directed free-play session conducted approximately 60 minutes before surgery. Children independently selected the play materials and directed the play while accompanied by one parent. The facilitator provided no therapeutic, educational, or medical guidance and only ensured the child's safety.
| Study group | Role | What they receive |
|---|---|---|
| Child-Directed Free-Play Group | Experimental | Children assigned to the intervention group participated in child-directed free play in the play and learning center approximately 60 minutes before surgery. Each session lasted approximately 40 minutes, and one parent accompanied the child. Children independently selected the play materials and type of play and determined how the play progressed. No therapeutic, educational, or medical guidance was provided. The facilitator did not direct the play and only ensured the child's safety. Receives: Behavioral: Child-Directed Free Play |
| Routine Preoperative Care Group | No intervention | Children assigned to the control group received routine preoperative care, including verification of patient identity and fasting status, monitoring of vital signs, surgical preparation, and standard nursing care. During the period corresponding to the free-play intervention, children remained with their parents in the routine clinical setting and received no study-related play intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's State Anxiety
Children's state anxiety was assessed using the Children's Anxiety Meter-State. Scores range from 0 to 10, with higher scores indicating greater state anxiety.
Measured: Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery
Change in Parental Anxiety
Parental anxiety was assessed using the Visual Analog Scale for Anxiety. Scores range from 0 to 100, with higher scores indicating greater anxiety.
Measured: Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery
Secondary outcomes (1)
Change in Children's Fear
Parental anxiety was assessed using the Visual Analog Scale for Anxiety. Scores range from 0 to 100, with higher scores indicating greater anxiety.
Measured: Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric NursingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa KARA, Osmaniye Korkut Ata University
- Investigators
- Mustafa KARA, PhD, Principal investigator, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335458
- Sponsor's protocol ID
- E.229701
- Other IDs
- OKÜBAP2025-GAP004
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Child-Directed Free Play on Preoperative Fear and Anxiety in Children and Parental Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07335458
- Acronym / sponsor ID
- E.229701
- Keywords
- Free play, Game-based intervention, Child-Directed Free Play, Pediatric Surgery, Family-Centered Care, Nonpharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 13 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.
The aim of this study was to determine the effect of free-play activities on preoperative fear and state anxiety in children aged 5-10 years and on parental anxiety. The research was conducted as a randomized controlled trial. The study population consisted of children aged 5-10 years and their parents who underwent planned surgical procedures in the pediatric surgery ward of a training and research hospital. Eligible child-parent dyads were recruited using a convenience sampling method and were then randomly assigned to the intervention and control groups.
The data collection process in the study was conducted in two stages, with intervention and control groups: pretest and posttest. Tests for both groups were administered before the planned surgical procedure. A pretest for the children and their parents in the intervention group was administered approximately 2 hours before the surgical procedure, just before the start of the free-play intervention. At this stage, baseline data were obtained by measuring the children's fear and state anxiety levels and the parents' anxiety levels.
Following this, the children participated in approximately 40 minutes of child-directed free play. A posttest was administered immediately after the free-play intervention, approximately 20 minutes before surgery. This measurement was used to evaluate the effect of free play on the dependent variables.
In the control group, no study-related intervention was applied, and routine preoperative care continued. This group was also assessed with a pretest approximately 2 hours before surgery and a posttest after the corresponding 40-minute period, approximately 20 minutes before surgery, to evaluate the children's fear and state anxiety levels and parental anxiety. This allowed the differences between the two groups to be compared. This timing was selected to assess children's anxiety and fear during the period when preoperative distress was expected to be high and to evaluate the immediate effect of free play.
Study Population: The study population consisted of children aged 5-10 years who underwent elective surgical procedures and their parents.
Study Sample: The study included children aged 5-10 years who underwent surgical procedures and one accompanying parent for each child. The child-parent dyads were randomly assigned to the intervention and control groups.
An a priori power analysis was performed using G*Power version 3.1.9.7. Based on Cohen's d = 0.65, an α level of .05, statistical power of 80%, and a 1:1 allocation ratio, at least 39 child-parent dyads were required in each group. To account for potential attrition or missing data, 80 child-parent dyads were recruited, with 40 assigned to the intervention group and 40 assigned to the control group.
The hypotheses of the study were:
H1a: The posttest Children's Fear Scale scores of children in the free-play group are lower than their pretest scores.
H1b: Children in the free-play group have lower posttest Children's Fear Scale scores than children in the control group.
H2a: The posttest Children's Anxiety Meter-State scores of children in the free-play group are lower than their pretest scores.
H2b: Children in the free-play group have lower posttest Children's Anxiety Meter-State scores than children in the control group.
H3a: Parents in the free-play group have lower posttest anxiety scores than their pretest scores.
H3b: Parents in the free-play group have lower posttest anxiety scores than parents in the control group.
H4: There are positive associations among parental anxiety, children's state anxiety, and children's fear levels both before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child-Directed Free-Play Group | Experimental | Behavioral: Child-Directed Free PlayChildren assigned to the intervention group participated in child-directed free play in the play and learning center approximately 60 minutes before surgery. Each session lasted approximately 40 minutes, and one parent accompanied the child. Children independently selected the play materials and type of play and determined how the play progressed. No therapeutic, educational, or medical guidance was provided. The facilitator did not direct the play and only ensured the child's safety. |
| Routine Preoperative Care Group | No intervention | –Children assigned to the control group received routine preoperative care, including verification of patient identity and fasting status, monitoring of vital signs, surgical preparation, and standard nursing care. During the period corresponding to the free-play intervention, children remained with their parents in the routine clinical setting and received no study-related play intervention. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Aged 5-10 years
- Scheduled to undergo ambulatory or inpatient surgery
- No chronic or neurological disease
- No cognitive, hearing, or visual impairment that could interfere with communication or completion of the study instruments
- Willing to participate and able to provide verbal assent
Key exclusion criteria (2 listed)
- Previous psychiatric diagnosis
- Current use of anxiolytic or sedative medication
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 |
|---|---|---|
| Child-Directed Free PlayA 40-minute child-directed free-play session conducted approximately 60 minutes before surgery. Children independently selected the play materials and directed the play while accompanied by one parent. The facilitator provided no therapeutic, educational, or medical guidance and only ensured the child's safety. | Behavioural | Child-Directed Free-Play Group |
Primary outcome
Change in Children's State Anxiety
Time frame: Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery
Children's state anxiety was assessed using the Children's Anxiety Meter-State. Scores range from 0 to 10, with higher scores indicating greater state anxiety.
Change in Parental Anxiety
Time frame: Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery
Parental anxiety was assessed using the Visual Analog Scale for Anxiety. Scores range from 0 to 100, with higher scores indicating greater anxiety.
1 secondary outcome
Change in Children's Fear
Time frame: Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery
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 10 Aug 2026.
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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.
Mustafa KARA, PhD principal investigator
Osmaniye Korkut Ata University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child-Directed Free Play in people with Pediatric Nursing and Preoperative Anxiety, run by Osmaniye Korkut Ata 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 10 inclusion and 2 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 10 Aug 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 (time frame: Baseline approximately 2 hours before surgery and immediately after the 40-minute intervention or corresponding control period, approximately 20 minutes before surgery). The study lists 2 primary outcomes in all. 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 10 Aug 2026.