Evaluation of Therapeutic Play Methods on Preoperative Anxiety and Acute Postoperative Symptoms in School-Age Children (TP-MAPAS)

Bilecik Seyh Edebali Universitesi

Status: Active, not recruiting

Conditions: Postoperative Complications; Preoperative Anxiety

Treatments: Other: Virtual Reality Play; Other: Smartphone Game Play; Other: Finger Puppet Play

Study type: Interventional

Funder types: Other

Identifiers

NCT07353697

E-10333602-050.04-253950

Details and patient eligibility

About

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?"

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Standard Maintenance

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Finger Puppet Play

Virtual Reality (VR) Game

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality Play

Smartphone-Based Game

Experimental group

Description:

This arm includes children who experience distraction and game-focused interaction guided by an age-appropriate smartphone game during the preoperative period.

Treatment:

Other: Smartphone Game Play