Preoperative Anxiety (Ameliyat Öncesi Anksiyete)PED-ANX-DELNCT07408037
Preoperative Gamified Breathing Exercise on Anxiety and Delirium in Children.
A study testing Gamified Breathing Exercises in people with Preoperative Anxiety (Ameliyat Öncesi Anksiyete) and Emergence Delirium (Derlenme Deliryumu), run by Bozok University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety (Ameliyat Öncesi Anksiyete), Emergence Delirium (Derlenme Deliryumu), Postoperative Complications
- What is being tested?
- Gamified Breathing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2024to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Uludağ Üniversitesi Hastanesi
Bursa, Bursa, 16130
Gulay ÖZTAŞ, 05548690708, oztas.gulay19@gmail.com
Gulay ÖZTAŞ, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Preoperative Anxiety (Ameliyat Öncesi Anksiyete), Emergence Delirium (Derlenme Deliryumu), Postoperative Complications, Pediatric Patients
- Being tested
- Gamified Breathing Exercises
- Keywords
- Preoperative Anxiety, Emergence Delirium, Gamification, Breathing Exercises, Pediatric Nursing, Postoperative Recovery
- Medical subject headings
- Emergence Delirium, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Breathing ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before the surgery (preoperative holding area).
Secondary outcomes (1)
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.
Measured: At 0, 15, and 30 minutes after arrival in the Post-Anesthesia Care Unit (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start3 Mar 2024
- Primary completion12 Nov 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preoperative Anxiety (Ameliyat Öncesi Anksiyete)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay Oztas, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408037
- Sponsor's protocol ID
- 2023-28 / 20
- Acronym
- PED-ANX-DEL
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36203819Shen 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.
PubMed 35943745Cai 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.
PubMed 38758221
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anxiety and Postoperative Recovery Delirium Observation in Children Who Underwent Gamified Breathing Exercise
- ClinicalTrials.gov ID
- NCT07408037
- Acronym / sponsor ID
- PED-ANX-DEL / 2023-28 / 20
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gamified Breathing Exercise Group | Experimental | Behavioral: Gamified Breathing ExercisesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified Breathing ExercisesThe 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. | Behavioural | Gamified Breathing Exercise Group |
Primary outcome
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.
1 secondary outcome
Postoperative Emergence Delirium Level
Time frame: At 0, 15, and 30 minutes after arrival in the Post-Anesthesia Care Unit (PACU).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Results publication: PubMed 36203819Yang 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.
- Results publication: PubMed 35943745Shen 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.
- Results publication: PubMed 38758221Cai 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Breathing Exercises in people with Preoperative Anxiety (Ameliyat Öncesi Anksiyete) and Emergence Delirium (Derlenme Deliryumu), run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gulay ÖZTAŞ, PhD (+905548690708, oztas.gulay19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Score (time frame: Immediately before the surgery (preoperative holding area).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07408037, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.