Preoperative AnxietyTP-MAPASNCT07353697
Evaluation of Therapeutic Play Methods on Preoperative Anxiety and Acute Postoperative Symptoms in School-Age Children
A study testing Finger Puppet Play, Virtual Reality Play and Smartphone Game Play in people with Preoperative Anxiety and Postoperative Complications, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of different therapeutic play methods (finger puppet play, virtual reality glasses, and smartphone games) applied to children aged 6-12 years during the preoperative period on their anxiety levels and postoperative acute symptoms. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Postoperative Complications
- What is being tested?
- Finger Puppet Play, Virtual Reality Play and Smartphone Game Play
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 12 years
- Hospitalized at Bilecik Training and Research Hospital, Department of Pediatric Surgery, for an elective surgical procedure
- Able to read and write
- Able to communicate in Turkish
- No visual, hearing, or speech impairments
- No intellectual disability or physical or surgical condition that would interfere with participation
- Voluntary participation with written informed consent obtained from the child and the parent or legal guardian
Who cannot join
- Children referred to the intensive care unit
- Children requiring repeat surgical intervention
- Children with a hospital stay of two days or longer
- Children with severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Training and Research Hospital
Bilecik, Bilecik, 11000
About this study
Official title: Evaluation of the Effects of Different Therapeutic Play Methods on Pre- and Post-operative Anxiety and Acute Symptoms in School-aged Children Aged 6-12
This study aims to evaluate the effect of different therapeutic play methods (finger puppet play, virtual reality glasses, and smartphone games) applied to children aged 6-12 years during the preoperative period on their anxiety levels and postoperative acute symptoms. The study has a randomized controlled design conducted in a pediatric surgery clinic. The research seeks to answer the following question: "Are different therapeutic play methods effective in reducing anxiety, fear, pain, and other acute symptoms in children during the surgical process?"
Read the detailed description
Psychological stress experienced by children prior to surgical intervention can increase autonomic nervous system activation, thereby affecting pain perception, nausea development, hemodynamic variability, and the recovery process during the perioperative period. Therapeutic play interventions are non-invasive interventions that support children's coping skills with the surgical process through mechanisms such as distraction, cognitive restructuring, and emotional regulation. In recent years, technology-based approaches such as virtual reality have begun to be used in pediatric surgery as an alternative or complementary component to traditional play methods. However, randomized controlled data comparing the effects of these methods on physiological and psychological responses are still limited.
This study employs an experimental design aimed at examining the capacity of different game-based interventions administered during the preoperative period to regulate children's stress response. The intervention protocols target different mechanisms, including visual-auditory stimulation, cognitive attention guidance, imaginative play, and the use of interactive digital stimuli. Physiological changes are monitored at standardized time points, and early responses of the autonomic response (heart rate, blood pressure, breathing pattern) to game-based distractions are recorded for evaluation. Psychological assessments are structured to measure the child's emotional regulation capacity, anxiety level, and behavioral responses during the surgical process in a multidimensional manner.
Additionally, the study includes an assessment of the perioperative care experience from the family perspective. This assessment aims to understand the potential indirect effects of play interventions on parent-child interaction, parental trust in healthcare, and parental involvement in the care process. The multi-arm design of the study allows for the comparison of different therapeutic play techniques and the determination of which intervention potentially has a stronger effect on specific clinical outcomes.
The data obtained in this context aims to reveal the applicability, clinical effect profiles, and potential areas of application of play-based interventions for non-pharmacological anxiety management in pediatric surgical practice.
- Conditions
- Preoperative Anxiety, Postoperative Complications
- Being tested
- Finger Puppet Play, Virtual Reality Play, Smartphone Game Play
- Keywords
- Pediatric surgery, play therapy, virtual reality, anxiety
- Medical subject headings
- Postoperative Complications, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger Puppet PlayOther
Finger Puppet Play - Intervention Description This intervention is a guided therapeutic play activity that involves the child interacting with age-appropriate finger puppets during the preoperative period. The application is conducted by the researcher according to a standard protocol and combines imaginative play with attention-focused play techniques. The intervention aims to regulate the child's emotions, divert their attention away from the surgical process, and create a relaxing play environment through puppet characters.
Virtual Reality PlayOther
Virtual Reality Play - Intervention Description This intervention involves directing the child to an age-appropriate visual-auditory gaming experience through virtual reality goggles. VR content provides interactive environments designed to distract the child's attention away from the surgical process. The application is carried out for a fixed period of time and according to a standardized protocol. The intervention is a technology-based distraction technique that aims to reduce anxiety and tension by providing multi-sensory stimulation.
Smartphone Game PlayOther
Smartphone Game Play - Intervention Description This intervention is based on the child playing an age-appropriate smartphone game selected by the researcher during the preoperative period. The application uses one-way or interactive game content and is carried out for a standard period of time. The intervention is designed as an easily accessible digital distraction method and aims to divert the child's cognitive focus away from the surgical process.
| Study group | Role | What they receive |
|---|---|---|
| Standard Maintenance | No intervention | This arm includes children who did not receive any therapeutic play intervention during the preoperative period and only underwent the standard clinical preparation process. |
| Finger Puppet Therapeutic Game | Experimental | This arm includes children who participated in the structured finger puppet therapeutic play activity administered by the researcher during the preoperative period. The intervention involves interaction with age-appropriate puppets and guided play-based distraction techniques. Receives: Other: Finger Puppet Play |
| Virtual Reality (VR) Game | Experimental | This arm includes children who participated in an interactive VR game experience using virtual reality goggles during the preoperative period. The intervention is based on visual and auditory stimuli aimed at distracting the child's attention from the surgical process. Receives: Other: Virtual Reality Play |
| Smartphone-Based Game | Experimental | This arm includes children who experience distraction and game-focused interaction guided by an age-appropriate smartphone game during the preoperative period. Receives: Other: Smartphone Game Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in State Anxiety Scores in Children During the Preoperative Period
Anxiety level is assessed using the State Anxiety Inventory for Children, which consists of 20 items with total scores ranging from 20 to 60. Higher scores indicate higher levels of anxiety, whereas lower scores indicate lower levels of anxiety. Anxiety assessments are conducted at four time points: preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); and approximately 30 minutes before discharge (Day 1).
Measured: Preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); approximately 30 minutes before discharge (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start10 May 2024
- Primary completion10 May 2025
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilek AYGİN, PROF. DR, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353697
- Sponsor's protocol ID
- E-10333602-050.04-253950
- Acronym
- TP-MAPAS
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected as part of the study will not be shared due to the inclusion of sensitive personal health information of child participants and the risk of re-identification. Access to IPD is restricted in accordance with data confidentiality and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Therapeutic Play Methods on Pre- and Post-operative Anxiety and Acute Symptoms in School-aged Children Aged 6-12
- ClinicalTrials.gov ID
- NCT07353697
- Acronym / sponsor ID
- TP-MAPAS / E-10333602-050.04-253950
- Conditions
- Preoperative Anxiety, Postoperative Complications
- Keywords
- Pediatric surgery, play therapy, virtual reality, anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 20 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 study aims to evaluate the effect of different therapeutic play methods (finger puppet play, virtual reality glasses, and smartphone games) applied to children aged 6-12 years during the preoperative period on their anxiety levels and postoperative acute symptoms. The study has a randomized controlled design conducted in a pediatric surgery clinic. The research seeks to answer the following question: "Are different therapeutic play methods effective in reducing anxiety, fear, pain, and other acute symptoms in children during the surgical process?"
Detailed description
Psychological stress experienced by children prior to surgical intervention can increase autonomic nervous system activation, thereby affecting pain perception, nausea development, hemodynamic variability, and the recovery process during the perioperative period. Therapeutic play interventions are non-invasive interventions that support children's coping skills with the surgical process through mechanisms such as distraction, cognitive restructuring, and emotional regulation. In recent years, technology-based approaches such as virtual reality have begun to be used in pediatric surgery as an alternative or complementary component to traditional play methods. However, randomized controlled data comparing the effects of these methods on physiological and psychological responses are still limited.
This study employs an experimental design aimed at examining the capacity of different game-based interventions administered during the preoperative period to regulate children's stress response. The intervention protocols target different mechanisms, including visual-auditory stimulation, cognitive attention guidance, imaginative play, and the use of interactive digital stimuli. Physiological changes are monitored at standardized time points, and early responses of the autonomic response (heart rate, blood pressure, breathing pattern) to game-based distractions are recorded for evaluation. Psychological assessments are structured to measure the child's emotional regulation capacity, anxiety level, and behavioral responses during the surgical process in a multidimensional manner.
Additionally, the study includes an assessment of the perioperative care experience from the family perspective. This assessment aims to understand the potential indirect effects of play interventions on parent-child interaction, parental trust in healthcare, and parental involvement in the care process. The multi-arm design of the study allows for the comparison of different therapeutic play techniques and the determination of which intervention potentially has a stronger effect on specific clinical outcomes.
The data obtained in this context aims to reveal the applicability, clinical effect profiles, and potential areas of application of play-based interventions for non-pharmacological anxiety management in pediatric surgical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Maintenance | No intervention | –This arm includes children who did not receive any therapeutic play intervention during the preoperative period and only underwent the standard clinical preparation process. |
| Finger Puppet Therapeutic Game | Experimental | Other: Finger Puppet PlayThis arm includes children who participated in the structured finger puppet therapeutic play activity administered by the researcher during the preoperative period. The intervention involves interaction with age-appropriate puppets and guided play-based distraction techniques. |
| Virtual Reality (VR) Game | Experimental | Other: Virtual Reality PlayThis arm includes children who participated in an interactive VR game experience using virtual reality goggles during the preoperative period. The intervention is based on visual and auditory stimuli aimed at distracting the child's attention from the surgical process. |
| Smartphone-Based Game | Experimental | Other: Smartphone Game PlayThis arm includes children who experience distraction and game-focused interaction guided by an age-appropriate smartphone game during the preoperative period. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6 to 12 years
- Hospitalized at Bilecik Training and Research Hospital, Department of Pediatric Surgery, for an elective surgical procedure
- Able to read and write
- Able to communicate in Turkish
- No visual, hearing, or speech impairments
Key exclusion criteria (4 listed)
- Children referred to the intensive care unit
- Children requiring repeat surgical intervention
- Children with a hospital stay of two days or longer
- Children with severe psychiatric disorders
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 |
|---|---|---|
| Finger Puppet PlayFinger Puppet Play - Intervention Description This intervention is a guided therapeutic play activity that involves the child interacting with age-appropriate finger puppets during the preoperative period. The application is conducted by the researcher according to a standard protocol and combines imaginative play with attention-focused play techniques. The intervention aims to regulate the child's emotions, divert their attention away from the surgical process, and create a relaxing play environment through puppet characters. | Other | Finger Puppet Therapeutic Game |
| Virtual Reality PlayVirtual Reality Play - Intervention Description This intervention involves directing the child to an age-appropriate visual-auditory gaming experience through virtual reality goggles. VR content provides interactive environments designed to distract the child's attention away from the surgical process. The application is carried out for a fixed period of time and according to a standardized protocol. The intervention is a technology-based distraction technique that aims to reduce anxiety and tension by providing multi-sensory stimulation. | Other | Virtual Reality (VR) Game |
| Smartphone Game PlaySmartphone Game Play - Intervention Description This intervention is based on the child playing an age-appropriate smartphone game selected by the researcher during the preoperative period. The application uses one-way or interactive game content and is carried out for a standard period of time. The intervention is designed as an easily accessible digital distraction method and aims to divert the child's cognitive focus away from the surgical process. | Other | Smartphone-Based Game |
Primary outcome
Changes in State Anxiety Scores in Children During the Preoperative Period
Time frame: Preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); approximately 30 minutes before discharge (Day 1)
Anxiety level is assessed using the State Anxiety Inventory for Children, which consists of 20 items with total scores ranging from 20 to 60. Higher scores indicate higher levels of anxiety, whereas lower scores indicate lower levels of anxiety. Anxiety assessments are conducted at four time points: preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); and approximately 30 minutes before discharge (Day 1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected as part of the study will not be shared due to the inclusion of sensitive personal health information of child participants and the risk of re-identification. Access to IPD is restricted in accordance with data confidentiality and ethical requirements.
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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.
Dilek AYGİN, PROF. DR principal investigator
Sakarya 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 Finger Puppet Play, Virtual Reality Play and Smartphone Game Play in people with Preoperative Anxiety and Postoperative Complications, run by Bilecik Seyh Edebali Universitesi 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in State Anxiety Scores in Children During the Preoperative Period (time frame: Preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); approximately 30 minutes before discharge (Day 1)). 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 20 Jan 2026.