Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06868420
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2025-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients
Sponsor:
University of Guadalajara
Organization:
Study Overview
Official Title:
Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients Aged 3 to 6 Years Undergoing Inguinal Hernioplasty
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: