Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients

Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients Aged 3 to 6 Years Undergoing Inguinal Hernioplasty

The goal of this randomized controlled clinical trial was to determine the efficacy of play therapy in reducing perioperative anxiety in pediatric patients aged 3 to 6 years undergoing inguinal hernia surgery.

The main research question was:

Was play therapy effective in reducing perioperative anxiety levels in pediatric patients undergoing inguinal hernia repair?

Primary outcome measure: Anxiety level.

Patients were randomized into two groups:

1. an intervention group, which received play therapy involving a transport cart and toys; and
2. a control group, which received anxiolytic medication and standard care.

Researchers compared the control group and the play therapy group to evaluate differences in anxiety levels using the Visual Analog Scale for Parents (VAS-P) and the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).

Study Overview

• Status: Completed
• Conditions: Perioperative Anxiety
• Intervention / Treatment: Behavioral: Play therapy with transport cart

Detailed Description

Design and Study Population:

A randomized controlled clinical trial with parallel groups was conducted involving pediatric patients aged 3 to 6 years who were scheduled for inguinal hernia repair at Dr. Juan I. Menchaca Civil Hospital in Guadalajara, Mexico. Participants were randomly assigned to one of two groups: the play therapy group or the control group.

The play therapy group received a play-based intervention using toys. After five minutes of playing with a transport cart, the children were transported to the operating room in the same cart.

The control group received oral midazolam (0.1 mg/kg). After five minutes, they were transferred to the operating room either in a caregiver's arms or on a standard stretcher.

The study was approved by the Ethics and Research Committees (60/HCJIM-JAL/2023).

Assessment and Management of Anxiety:

Perioperative anxiety was assessed using two instruments:

The Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF), completed by the anesthesiologist.

The Visual Analog Scale for Parents (VAS-P), which measured anxiety as perceived by the child's parent or guardian.Both instruments were applied at three time points:

1. Upon initial contact with the anesthesiologist
2. After the intervention (play-based or pharmacological)
3. Upon arrival in the operating room Additionally, midazolam was administered as rescue therapy for any patient exhibiting significant anxiety (mYPAS-SF score > 30 following the intervention).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • University of Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients aged 3 to 6 years.
• Patients of any sex.
• Patients scheduled for elective inguinal hernioplasty.
• Patients undergoing their first anesthetic-surgical procedure.
• Patients whose legal guardian provided informed consent.

Exclusion Criteria:

• Patients with known allergy to midazolam.
• Patients with abnormal perinatal history (e.g., neonatal hypoxia or chromosomal abnormalities).
• Patients undergoing emergency inguinal hernioplasty due to complications such as strangulation or incarceration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL / STANDARD CARE; This group received standard care, including oral midazolam (0.1 mg/kg) as an anxiolytic before surgery.
Experimental: Play Therapy With Transport Cart; This group received a play-based intervention consisting of five minutes of play with a toy transport cart, after which the child was transported to the operating room using the same cart.	Behavioral: Play therapy with transport cart; he intervention consisted of allowing pediatric patients to engage in five minutes of play with a toy transport cart, after which they were transported to the operating room in the same cart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Assessment of Child Anxiety Levels	The child's anxiety levels were assessed by their parent or legal guardian using the Visual Analog Anxiety Scale for Parents (VAS-P). Baseline anxiety was measured at the first contact with the anesthesiologist. The VAS-P is a 10 cm horizontal scale, where values greater than 5 cm indicate significant anxiety.	Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).
Anesthesiologist Assessment of Child Anxiety Levels	The child's anxiety levels were assessed by the anesthesiologist using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Baseline anxiety was recorded at the first contact with the anesthesiologist. The mYPAS-SF provides scores ranging from 22.9 to 100 points, with values greater than 30 indicating the presence of significant anxiety.	Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).

Collaborators and Investigators

• Sponsor: University of Guadalajara

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): July 23, 2023
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Herniorrhaphy; Perioperative Anxiety; Pediatric Surgery; Play Therapy; Anxiety Assessment
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PL4Y-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No