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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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). |
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Inclusion Criteria:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gulay ÖZTAŞ, PhD | Contact | +905548690708 | oztas.gulay19@gmail.com | |
| Gulay ÖZTAŞ, PhD | Contact | 05548690708 | oztas.gulay19@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Uludağ Üniversitesi Hastanesi | Recruiting | Bursa | Bursa | 16130 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36203819 | Result | 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. | |
| 35943745 | Result |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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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.
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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.
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| 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. |
| 38758221 | 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. |
| D009422 |
| Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |