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Preoperative Gamified Breathing Exercise on Anxiety and Delirium in Children.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07408037
Acronym
PED-ANX-DEL
Enrollment
80
Registered
2026-02-12
Start date
2024-03-03
Completion date
2026-12-12
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium (Derlenme Deliryumu), Pediatric Patients, Postoperative Complications, Preoperative Anxiety (Ameliyat Öncesi Anksiyete)

Keywords

Preoperative Anxiety, Emergence Delirium, Gamification, Breathing Exercises, Pediatric Nursing, Postoperative Recovery

Brief summary

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.

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.

Interventions

BEHAVIORALGamified 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.

Sponsors

Bozok University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The primary and secondary outcomes (anxiety and delirium scores) are assessed by a blinded assistant researcher and a recovery room nurse who are unaware of the group assignments (intervention vs. control). This ensures that the evaluation of the Modified Yale Preoperative Anxiety Scale (mYPAS-SF) and the Pediatric Anesthesia Emergence Delirium (PAED) scale is conducted without bias.

Intervention model description

A randomized controlled, parallel-group trial design is used to compare the effects of preoperative gamified breathing exercises with routine care. Participants are assigned to either the intervention group or the control group using a randomization method with numbered cards. Both groups receive the same baseline measurements, but only the intervention group undergoes the gamified breathing exercise protocol before surgery.

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Preoperative Anxiety ScoreImmediately 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

MeasureTime frameDescription
Postoperative Emergence Delirium LevelAt 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTGulay ÖZTAŞ, PhD
oztas.gulay19@gmail.com+905548690708

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026