Preoperative Gamified Breathing Exercise on Anxiety and Delirium in Children. (PED-ANX-DEL)

Preoperative Anxiety and Postoperative Recovery Delirium Observation in Children Who Underwent Gamified Breathing Exercise

This study aims to evaluate the effect of preoperative gamified breathing exercises on preoperative anxiety and postoperative emergence delirium in children. The intervention includes games like ball blowing and bubble blowing. Anxiety is measured using the mYPAS-SF scale, and delirium is assessed with the PAED scale.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Pediatric Patients; Preoperative Anxiety (Ameliyat Öncesi Anksiyete); Emergence Delirium (Derlenme Deliryumu)
• Intervention / Treatment: Behavioral: Gamified Breathing Exercises

Detailed Description

This randomized controlled study investigates the impact of preoperative gamified breathing exercises on preoperative anxiety and postoperative emergence delirium in pediatric patients. Children in the intervention group and their parents receive specialized training on gamified breathing exercises starting 48-72 hours before surgery.

The intervention consists of various interactive breathing games selected based on the child's preference, including:

Ball Blowing: Blowing a cotton or ping-pong ball across a flat surface or into a 'goal' using a straw to encourage deep exhalation.

Bubble Blowing: Using soap bubbles to promote slow and controlled breathing patterns.

Tissue/Paper Blowing: Blowing on tissues to lift them or move paper windmills.

Candle Blowing: Simulating or practicing blowing out candles using different breath strengths.

Participants are asked to perform these exercises for 10 minutes every hour, approximately 10-15 times per day, until the time of surgery. The control group receives routine preoperative information and care.

Primary outcomes are measured using the Modified Yale Preoperative Anxiety Scale (mYPAS-SF) before the operation. Postoperative emergence delirium is assessed in the recovery room at 0, 15, and 30 minutes using the Pediatric Anesthesia Emergence Delirium (PAED) scale."

Bu Bölümden Sonraki Adım: Arms and Interventions Bu metni kaydedip ilerlediğinizde, sistem sizden grupları (Arms) ve müdahaleleri (Interventions) ayrı ayrı tanımlamanızı isteyecektir.

Arm 1 (Experimental): Gamified Breathing Exercise Group.

Arm 2 (No Intervention/Control): Routine Care Group.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gulay ÖZTAŞ, PhD; Phone Number: +905548690708; Email: oztas.gulay19@gmail.com
• Study Contact Backup: Name: Gulay ÖZTAŞ, PhD; Phone Number: 05548690708; Email: oztas.gulay19@gmail.com

Study Locations

• Turkey (Türkiye)
  • Bursa
    • Bursa, Bursa, Turkey (Türkiye), 16130
      • Recruiting
      • Bursa Uludag Universitesi Hastanesi
      • Contact: Gulay ÖZTAŞ; Phone Number: 05548690708; Email: oztas.gulay19@gmail.com
      • Principal Investigator: Gulay ÖZTAŞ, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children aged 3 to 7 years (preschool age).

Scheduled for elective (planned) surgery at Bursa Uludag University Hospital.

Physical status classified as ASA I or ASA II.

Children and parents who volunteer to participate and provide written informed consent.

Exclusion Criteria:

Children with chronic neurological or psychiatric disorders.

Children with existing respiratory system diseases that prevent breathing exercises.

Children or parents with communication barriers (e.g., severe hearing or speech impairment).

Children undergoing emergency (non-elective) surgery.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gamified Breathing Exercise Group; Participants in this group receive preoperative training on gamified breathing exercises. The intervention includes various interactive breathing games such as ball blowing, bubble blowing, candle blowing, or using breathing apps. Children are asked to perform these exercises for 10 minutes every hour, approximately 10-15 times per day, from 48-72 hours before surgery until the day of the operation.	Behavioral: Gamified Breathing Exercises; The intervention involves providing preoperative training to children and their parents on gamified breathing exercises starting 48-72 hours before surgery. Children choose from various interactive breathing games, including: Ball Blowing: Blowing cotton or ping-pong balls across a surface using a straw. Bubble Blowing: Blowing soap bubbles to promote slow, deep exhalation. Candle Blowing: Practicing controlled breathing by blowing out candles. Tissue/Paper Blowing: Using breath to lift tissues or move paper windmills. Participants are instructed to practice these games for 10 minutes every hour, approximately 10-15 times per day, until the day of surgery. All necessary equipment (straws, bubbles, toys) is provided by the researchers.
No Intervention: No Intervention; his group receives routine preoperative information and standard care only. No gamified breathing exercises are practiced by the participants in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Anxiety Score	This will be assessed using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). The scale evaluates five categories of behavior: activity, vocalization, emotional expressivity, state of arousal, and use of parents. Scores range from 22.92 to 100, where higher scores indicate higher levels of anxiety.	Immediately before the surgery (preoperative holding area).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Emergence Delirium Level	This will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. Scores range from 0 to 20, with a score of 10 or higher indicating the presence of emergence delirium.	At 0, 15, and 30 minutes after arrival in the Post-Anesthesia Care Unit (PACU).

Collaborators and Investigators

• Sponsor: Bozok University

Publications and helpful links

General Publications

• King-Underwood L, Pritchard-Jones K. Wilms' tumor (WT1) gene mutations occur mainly in acute myeloid leukemia and may confer drug resistance. Blood. 1998 Apr 15;91(8):2961-8.
• Ebrahim GJ. The urban child's health and environment. J Trop Pediatr. 1997 Oct;43(5):253-4. doi: 10.1093/tropej/43.5.253. No abstract available.
• Barreto Filho JB, Eiras PR, Golgher RR. N-terminal amino acids of bovine alpha interferons are relevant for the neutralization of their antiviral activity. Braz J Med Biol Res. 2001 May;34(5):663-7. doi: 10.1590/s0100-879x2001000500015.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2024
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): December 12, 2026

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Preoperative Anxiety; Breathing Exercises; Gamification; Emergence Delirium; Pediatric Nursing; Postoperative Recovery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Postoperative Complications
• Other Study ID Numbers: 2023-28 / 20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No