Clinical trial NCT06868420: Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients
Official title: Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients Aged 3 to 6 Years Undergoing Inguinal Hernioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Anxiety
Keywords: Pediatric Surgery
Anxiety Assessment
Herniorrhaphy
Play Therapy
Perioperative Anxiety
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Parental Assessment of Child Anxiety Levels
timeFrame: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).
measure: Anesthesiologist Assessment of Child Anxiety Levels
timeFrame: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: University of Guadalajara
state: Jalisco
Study officials:
References: