Anxiety StateNCT05931770
The Effect of Child Choice With Accompanying Parent on Postoperative Delirium During Induction of Anesthesia
An observational study of Anxiety State and Child Behavior, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Child Behavior, Postoperative Delirium
- What is being tested?
- Selection of parent(mother or father) according to children preference and Parent (mother or father) selection according to parents' preference
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2023to 28 Sep 2023
- 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
- Healthy volunteers accepted
- Child
Study population: The study included 80 children of both genders, aged 5-12 years, who underwent day-case surgeries in the Ear Nose and Throat Clinic with ASA physical Status I-II will be enrolled
Who may be able to join
- 5-12 years aged children
- ASA physical Status I-II
- Who underwent day-case surgeries in the Ear Nose and Throat Clinic
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, 70200
About this study
Official title: The Effect of Child Choice With Accompanying Parent on Pediatric Anxiety and Postoperative Delirium During Induction of Anesthesia During Day Case Surgeries.
Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs.
The aim of this study will be to evaluate whether the children's or parental preference with attending parent affects on the postoperative delirium of the children or not. The delirium of the children will be assessed by the Pediatric Anesthesia Occurrence Delirium Scale (PAED)
Read the detailed description
Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety. Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety and postoperative delirium not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS and postoperative delirium by using PAED.
- Conditions
- Anxiety State, Child Behavior, Postoperative Delirium
- Being tested
- Selection of parent(mother or father) according to children preference, Parent (mother or father) selection according to parents' preference
- Keywords
- day- case surgery, anxiety children, Postoperative Delirium
- Medical subject headings
- Anxiety Disorders, Child Behavior, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selection of parent(mother or father) according to children preferenceProcedure or surgery
The parent who will accompany the child during the perioperative period will be determined by the child. will be determined by children preference
Parent (mother or father) selection according to parents' preferenceProcedure or surgery
Accompanying parentwho will accompany during the perioperative period will be determined by the parents. to be determined by
| Study group | Role | What they receive |
|---|---|---|
| Group Child Preference | The children will prefer parents (mother or father) who will accompany them in the preoperative holding area and at induction Receives: Procedure: Selection of parent(mother or father) according to children preference | |
| Group Parent's Preference | Parents will decide among themselves and prefer the parents (mother or father) who will accompany them from the side of the parent, in the pre-operative waiting area and during induction. Receives: Procedure: Parent (mother or father) selection according to parents' preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start4 Jul 2023
- Primary completion27 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatih Yücedağ, Assist Prof, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931770
- Sponsor's protocol ID
- 06-2023/11
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2023
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Child Choice With Accompanying Parent on Pediatric Anxiety and Postoperative Delirium During Induction of Anesthesia During Day Case Surgeries.
- ClinicalTrials.gov ID
- NCT05931770
- Acronym / sponsor ID
- 06-2023/11
- Conditions
- Anxiety State, Child Behavior, Postoperative Delirium
- Keywords
- day- case surgery, anxiety children, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 5 Jul 2023 (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.
Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs.
The aim of this study will be to evaluate whether the children's or parental preference with attending parent affects on the postoperative delirium of the children or not. The delirium of the children will be assessed by the Pediatric Anesthesia Occurrence Delirium Scale (PAED)
Detailed description
Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety. Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety and postoperative delirium not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS and postoperative delirium by using PAED.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Child Preference | – | Procedure: Selection of parent(mother or father) according to children preferenceThe children will prefer parents (mother or father) who will accompany them in the preoperative holding area and at induction |
| Group Parent's Preference | – | Procedure: Parent (mother or father) selection according to parents' preferenceParents will decide among themselves and prefer the parents (mother or father) who will accompany them from the side of the parent, in the pre-operative waiting area and during induction. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study included 80 children of both genders, aged 5-12 years, who underwent day-case surgeries in the Ear Nose and Throat Clinic with ASA physical Status I-II will be enrolled
Key inclusion criteria (3 listed)
- 5-12 years aged children
- ASA physical Status I-II
- Who underwent day-case surgeries in the Ear Nose and Throat Clinic
Key exclusion criteria (7 listed)
- Mentally challenged
- Deaf Child
- Cerebral Palsy
- Premedicated Child
- Language Problem
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 parent(mother or father) according to children preferenceThe parent who will accompany the child during the perioperative period will be determined by the child. will be determined by children preference | Procedure or surgery | Group Child Preference |
| Parent (mother or father) selection according to parents' preferenceAccompanying parentwho will accompany during the perioperative period will be determined by the parents. to be determined by | Procedure or surgery | Group Parent's Preference |
Primary outcome
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room
Time frame: Postoperative 1st day
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
1 secondary outcome
Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.
Time frame: Perioperative period
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 29 Sep 2023.
Related trials for Anxiety State
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
Fatih Yücedağ, Assist Prof 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 Anxiety State and Child Behavior, 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 3 inclusion and 7 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 29 Sep 2023. 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?
Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room (time frame: Postoperative 1st day). 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 29 Sep 2023.