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NCT Number: NCT07408037

Preoperative Gamified Breathing Exercise on Anxiety and Delirium in Children.

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.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludağ Üniversitesi Hastanesi

Bursa, 16130, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gulay ÖZTAŞ

CONTACT

[email protected]

05548690708

Gulay ÖZTAŞ, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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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Treatment and study plan

Gamified Breathing Exercises

Behavioral

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.

Primary outcomes

  1. Preoperative Anxiety Score

    Time frame: Immediately before the surgery (preoperative holding area).

    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.

Secondary outcomes

  1. Postoperative Emergence Delirium Level

    Time frame: At 0, 15, and 30 minutes after arrival in the Post-Anesthesia Care Unit (PACU).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gulay ÖZTAŞ, PhD

CONTACT

[email protected]

+905548690708

Gulay ÖZTAŞ, PhD

CONTACT

[email protected]

05548690708

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

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

Acronym: PED-ANX-DEL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

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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