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

NCT06868420 | Completed

• 1 other identifier: PL4Y-2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perioperative Anxiety

Keywords

Pediatric Surgery; Anxiety Assessment; Herniorrhaphy; Play Therapy; Perioperative Anxiety

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (2)

CONTROL / STANDARD CARE

NO INTERVENTION

This group received standard care, including oral midazolam (0.1 mg/kg) as an anxiolytic before surgery.

Play Therapy With Transport Cart

EXPERIMENTAL

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

Interventions

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.

Play Therapy With Transport Cart

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

University of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

MeSH Terms

Interventions

Play Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal investigator

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 11, 2025
• Study Start: January 19, 2023
• Primary Completion: July 23, 2023
• Study Completion: March 20, 2024
• Last Updated: April 15, 2025

Record last verified: 2024-04

Locations

ME (1)