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Completed

NCT Number: NCT06868420

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

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).

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Key information

Conditions

Perioperative Anxiety

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

About this study

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:

  • Upon initial contact with the anesthesiologist
  • After the intervention (play-based or pharmacological)
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Play therapy with transport cart

Behavioral

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.

Primary outcomes

  1. Parental Assessment of Child Anxiety Levels

    Time frame: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).

    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.

  2. Anesthesiologist Assessment of Child Anxiety Levels

    Time frame: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).

    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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 11, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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