Preoperative Gamified Breathing Exercise on Anxiety and Delirium in Children.

NCT07408037 | Recruiting

• 1 other identifier: 2023-28 / 20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Emergence Delirium Level

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

Study Arms (2)

Gamified Breathing Exercise Group

EXPERIMENTAL

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

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.

Interventions

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.

Gamified Breathing Exercise Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Bursa Uludağ Üniversitesi Hastanesi

Bursa, Bursa, 16130, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Yang X, Lin C, Chen S, Huang Y, Cheng Q, Yao Y. Remimazolam for the Prevention of Emergence Delirium in Children Following Tonsillectomy and Adenoidectomy Under Sevoflurane Anesthesia: A Randomized Controlled Study. Drug Des Devel Ther. 2022 Sep 30;16:3413-3420. doi: 10.2147/DDDT.S381611. eCollection 2022.

  PMID: 36203819 RESULT

• Shen F, Zhang Q, Xu Y, Wang X, Xia J, Chen C, Liu H, Zhang Y. Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225473. doi: 10.1001/jamanetworkopen.2022.25473.

  PMID: 35943745 RESULT

• Cai YH, Zhong JW, Ma HY, Szmuk P, Wang CY, Wang Z, Zhang XL, Dong LQ, Liu HC. Effect of Remimazolam on Emergence Delirium in Children Undergoing Laparoscopic Surgery: A Double-blinded Randomized Trial. Anesthesiology. 2024 Sep 1;141(3):500-510. doi: 10.1097/ALN.0000000000005077.

  PMID: 38758221 RESULT

MeSH Terms

Conditions

Emergence Delirium; Postoperative Complications

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Gulay ÖZTAŞ, PhD

CONTACT

+905548690708; oztas.gulay19@gmail.com

Gulay ÖZTAŞ, PhD

CONTACT

05548690708; oztas.gulay19@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 12, 2026
• Study Start: March 3, 2024
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

TU (1)