Perioperative AnxietyNCT06459089
The Effects of Familiar Toy and Parental Presence Combination on Perioperative Pediatric Anxiety
An observational study of Perioperative Anxiety and Emergence Delirium, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. Half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Perioperative Anxiety, Emergence Delirium
- What is being tested?
- Selection of the parent according to children preference and Bringing the favorite toy of the children that will accompany the child during their perioperative period
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2024to 18 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- Child
Study population: 100 child patients between the ages of 5-12 who will undergo ENT surgery
Who may be able to join
- Patients with ASA 1 and 2, Those who have the ability to speak and obey commands will be included.
Who cannot join
- Mentally challenged Deaf Child Cerebral Palsy Premedicated Child Language Problem Unco-operative Previous surgery or anesthesia history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman
About this study
Official title: The Effects of Familiar Toy and Parental Presence on Perioperative Pediatric Anxiety
This study will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. Half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own selected parent.
Read the detailed description
To reduce the incidence of preoperative anxiety in children, anesthesiologists have used a number of prevention strategies, including sedative premedication, parental presence during anesthetic induction, behavioral preparation programs, music therapy, hypnosis, and acupuncture.One of these distraction tool is familiar toy, children may also be comforted by familiar toys. Therefore, parent presence during perioperative period or playing with a favorite toy seems likely to alleviate preoperative anxiety in children. Until now, combination of these two method to reduce anxiety is not observed in literature. Then, the aim of this observational study is to evaluate the effect of both presence of favorite toy and parental presence compare to only parental presence during perioperative period on anxiety and emergence delirium in patients undergoing ambulatory surgery in our hospital's otorhinolaryngology department.
- Conditions
- Perioperative Anxiety, Emergence Delirium
- Being tested
- Selection of the parent according to children preference, Bringing the favorite toy of the children that will accompany the child during their perioperative period
- Keywords
- Anxiety State, Familiar Toy, Child Behavior
- Medical subject headings
- Emergence Delirium, Anxiety Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selection of the parent according to children preferenceBehavioural
The children will select the parent who will accompany them during the anesthesia induction
Bringing the favorite toy of the children that will accompany the child during their perioperative periodBehavioural
The children will bring tiheir favorite toy that will accompany them during their perioperative period
| Study group | Role | What they receive |
|---|---|---|
| Group1 | The children will select the parent who acoompany theim during anesthesia induction Receives: Behavioral: Selection of the parent according to children preference | |
| Group 2 | The children will select the parent who accompany them dring anesthesia induction and bring their favorite toy also to the operating room. Receives: Behavioral: Selection of the parent according to children preference; Behavioral: Bringing the favorite toy of the children that will accompany the child during their perioperative period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.
The mYPAS will be used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 22.9 to 100, with higher scores indicating greater anxiety.
Measured: Perioperative period
Secondary outcomes (1)
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room
Incidence of post-anesthesia and postoperative delirium Discordant behaviors assessed with Pediatric Anesthesia Emergence Delirium Scale (PAED) with five features, each scored using a 5-point Likert scale
Measured: Postoperative 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start26 Jun 2024
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnxietyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşe Duran, MD, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459089
- Sponsor's protocol ID
- 01-2024/13
- Status last verified
- Sep 2024
- First submitted
- 10 Jun 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Familiar Toy and Parental Presence on Perioperative Pediatric Anxiety
- ClinicalTrials.gov ID
- NCT06459089
- Acronym / sponsor ID
- 01-2024/13
- Conditions
- Perioperative Anxiety, Emergence Delirium
- Keywords
- Anxiety State, Familiar Toy, Child Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 14 Jun 2024 (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 will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. Half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own selected parent.
Detailed description
To reduce the incidence of preoperative anxiety in children, anesthesiologists have used a number of prevention strategies, including sedative premedication, parental presence during anesthetic induction, behavioral preparation programs, music therapy, hypnosis, and acupuncture.One of these distraction tool is familiar toy, children may also be comforted by familiar toys. Therefore, parent presence during perioperative period or playing with a favorite toy seems likely to alleviate preoperative anxiety in children. Until now, combination of these two method to reduce anxiety is not observed in literature. Then, the aim of this observational study is to evaluate the effect of both presence of favorite toy and parental presence compare to only parental presence during perioperative period on anxiety and emergence delirium in patients undergoing ambulatory surgery in our hospital's otorhinolaryngology department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Behavioral: Selection of the parent according to children preferenceThe children will select the parent who acoompany theim during anesthesia induction |
| Group 2 | – | Behavioral: Selection of the parent according to children preference, Behavioral: Bringing the favorite toy of the children that will accompany the child during their perioperative periodThe children will select the parent who accompany them dring anesthesia induction and bring their favorite toy also to the operating room. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- 100 child patients between the ages of 5-12 who will undergo ENT surgery
Key inclusion criteria (1 listed)
- Patients with ASA 1 and 2, Those who have the ability to speak and obey commands will be included.
Key exclusion criteria (1 listed)
- Mentally challenged Deaf Child Cerebral Palsy Premedicated Child Language Problem Unco-operative Previous surgery or anesthesia history
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 |
|---|---|---|
| Selection of the parent according to children preferenceThe children will select the parent who will accompany them during the anesthesia induction | Behavioural | Group 2, Group1 |
| Bringing the favorite toy of the children that will accompany the child during their perioperative periodThe children will bring tiheir favorite toy that will accompany them during their perioperative period | Behavioural | Group 2 |
Primary outcome
Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.
Time frame: Perioperative period
The mYPAS will be used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 22.9 to 100, with higher scores indicating greater anxiety.
1 secondary outcome
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room
Time frame: Postoperative 1st day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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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. This study is not recruiting at the moment.
Ayşe Duran, MD principal investigator
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Anxiety and Emergence Delirium, run by Karaman Training and Research Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia. (time frame: Perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.