Anxiety StateNCT06634680
Effects of Different Parental Involvement on Anxiety and Delirium
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 in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. 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
- What is being tested?
- Procedure: Selection of parent(mother or father) according to children preference and Procedure: Both parents will accompany the children.
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 12 Dec 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
- Healthy volunteers accepted
- Child
Study population: The study included 80 children of both genders, aged 5-12 years, who underwent day-case surgery in the otorhinolaryngology clinic
Who may be able to join
- 80 children of both sex, aged 5-12 years with ASA physical Status I-II will be enrolled
Who cannot join
- Mentally challenged
- Deaf Child
- Cerebral Palsy
- Premedicated Child
- Language Problem
- Uncooperative
- History of psychiatric disease in children or the parents
- Previous surgery or anesthesia history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Parental Involvement on Anxiety and Delirium in Children Undergoing Elective ENT Surgery
Induction of anesthesia in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. The effect of having both parents present during anesthesia induction on children's anxiety and parents' anxiety has not yet been documented.
This study will aim to evaluate the effect of having both parents present during anesthesia induction on children's and parental anxiety during the perioperative period.
Read the detailed description
Surgery can be very stressful for patients, especially children. Studies show that 50-75% of children experience fear and anxiety when undergoing surgery and being put under anesthesia. This anxiety can have adverse effects on their recovery, leading to more extended hospital stays, increased pain, and behavioral issues. To address this, various medical and non-medical approaches are used to ease children's fears. One such approach is allowing parents to be with their children until the anesthesia takes effect. This study aims to assess how having both parents present during this time impacts the child's anxiety levels.
The effect of parental presence on the anxiety of children and parents was studied in various studies. Whether both parents affect anxiety has not been studied yet. In this study the investigators will evaluate the anxiety of children by using mYPAS.
- Conditions
- Anxiety State, Child Behavior
- Being tested
- Procedure: Selection of parent(mother or father) according to children preference, Procedure: Both parents will accompany the children.
- Keywords
- anxiety, children, anesthesia,general
- Medical subject headings
- Anxiety Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Selection of parent(mother or father) according to children preferenceProcedure or surgery
Children will choose the parent who will accompany them.
Procedure: Both parents will accompany the children.Procedure or surgery
Both parents will accompany the children.
| 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: Procedure: Selection of parent(mother or father) according to children preference | |
| Group Both Parents | Both parents will accompany the child in the preoperative holding area and at induction. Receives: Procedure: Procedure: Both parents will accompany the children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients anxiety-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 23.3 to 100, with higher scores indicating greater anxiety.
Measured: Perioperative period
Secondary outcomes (2)
Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)
Pediatric Anaesthesia Emergence Delirium (PAED) scale consists of 5 criteria (eye contact, purposeful movement, awareness of environment, restlessness, inconsolability) that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The score changes 0-20. Scores above 10 indicate delirium, while scores below 10 indicate no delirium.
Measured: Perioperative period
Parent anxiety-STAI
The State-Trait Anxiety Inventory (STAI) was used to evaluate the anxiety level of the parents. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate 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 posted10 Oct 2024
- Study start15 Oct 2024
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Rafet YARIMOGLU, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634680
- Sponsor's protocol ID
- 04- 2024/15
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yarimoglu R, Sezgin A, Duran A, Yucedag F, Basaran B. The Impact of the Presence of Both Parents on Perioperative Anxiety in Children Undergoing Adenotonsillectomy Surgery: A Randomized Clinical Trial. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70167. doi: 10.1111/aas.70167.
PubMed 41423202
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Parental Involvement on Anxiety and Delirium in Children Undergoing Elective ENT Surgery
- ClinicalTrials.gov ID
- NCT06634680
- Acronym / sponsor ID
- 04- 2024/15
- Conditions
- Anxiety State, Child Behavior
- Keywords
- anxiety, children, anesthesia,general
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 10 Oct 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.
Induction of anesthesia in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. The effect of having both parents present during anesthesia induction on children's anxiety and parents' anxiety has not yet been documented.
This study will aim to evaluate the effect of having both parents present during anesthesia induction on children's and parental anxiety during the perioperative period.
Detailed description
Surgery can be very stressful for patients, especially children. Studies show that 50-75% of children experience fear and anxiety when undergoing surgery and being put under anesthesia. This anxiety can have adverse effects on their recovery, leading to more extended hospital stays, increased pain, and behavioral issues. To address this, various medical and non-medical approaches are used to ease children's fears. One such approach is allowing parents to be with their children until the anesthesia takes effect. This study aims to assess how having both parents present during this time impacts the child's anxiety levels.
The effect of parental presence on the anxiety of children and parents was studied in various studies. Whether both parents affect anxiety has not been studied yet. In this study the investigators will evaluate the anxiety of children by using mYPAS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Child Preference | – | Procedure: 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 Both Parents | – | Procedure: Procedure: Both parents will accompany the children.Both parents will accompany the child in the preoperative holding area and at 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 surgery in the otorhinolaryngology clinic
Key inclusion criteria (1 listed)
- 80 children of both sex, aged 5-12 years with ASA physical Status I-II will be enrolled
Key exclusion criteria (8 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 |
|---|---|---|
| Procedure: Selection of parent(mother or father) according to children preferenceChildren will choose the parent who will accompany them. | Procedure or surgery | Group Child Preference |
| Procedure: Both parents will accompany the children.Both parents will accompany the children. | Procedure or surgery | Group Both Parents |
Primary outcome
Patients anxiety-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 23.3 to 100, with higher scores indicating greater anxiety.
2 secondary outcomes
Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)
Time frame: Perioperative period
Parent anxiety-STAI
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 16 Dec 2024.
- Derived from this study: PubMed 41423202Yarimoglu R, Sezgin A, Duran A, Yucedag F, Basaran B. The Impact of the Presence of Both Parents on Perioperative Anxiety in Children Undergoing Adenotonsillectomy Surgery: A Randomized Clinical Trial. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70167. doi: 10.1111/aas.70167.
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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.
Rafet YARIMOGLU 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 1 inclusion and 8 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 16 Dec 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?
Patients anxiety-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?
On the ClinicalTrials.gov record for NCT06634680, which also lists 1 linked publication.
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 16 Dec 2024.