Preoperative AnxietyNCT07403773
Personal Versus Hospital-Provided Dolls in Preschool Children
An observational study of Preoperative Anxiety and Emergence Delirium in Pediatric Anesthesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to evaluate the effects of personal versus hospital-provided dolls on preoperative anxiety and postoperative delirium in preschool children aged 3-7 years undergoing elective adenoidectomy and/or tonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 7 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia
- What is being tested?
- Hospital-Provided Doll, Personal Doll and No Doll
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Child
Study population: Female pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Who may be able to join
- Female children aged 3-7 years
- Scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
- Able to communicate verbally
- ASA physical status I or II, according to the American Society of Anesthesiologists classification
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Presence of psychiatric, neurological, or developmental disorders
- Presence of chronic pain or ongoing medical treatment that may affect anxiety levels
- Refusal to participate despite repeated encouragement by the investigators
- Use of additional anxiety-reducing methods or medications outside the study protocol prior to intervention
- Previous surgical experience
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
Ankara Bilkent City Hospital
Ankara, ÇANKAYA, 06800
Filiz Kaya, M.D., 03125526000, filiz.kaya17@saglik.gov.tr
About this study
Official title: Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children
The goal of this study is to evaluate the effects of personal versus hospital-provided dolls on preoperative anxiety and postoperative delirium in preschool children aged 3-7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
Read more
- Is the use of a personal doll or a hospital-provided doll associated with lower preoperative anxiety compared with no doll use?
- Is dolls used associated with a reduced incidence and severity of postoperative emergence delirium?
- Researchers will compare children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll to assess differences in preoperative anxiety levels, serum cortisol concentrations, and postoperative delirium scores.
Participants will:
- Be observed in one of three exposure groups (hospital-provided doll, personal doll, or no doll)
- Undergo standardized preoperative anxiety assessments at predefined time points
- Have serum cortisol levels measured during routine intravenous cannulation
- Be assessed for postoperative delirium in the recovery unit
Read the detailed description
This study is designed to evaluate the association between doll use and preoperative anxiety as well as postoperative emergence delirium in preschool children undergoing elective adenoidectomy and/or tonsillectomy. The study population consists of female children aged 3-7 years who meet the eligibility criteria and are scheduled for elective surgery under general anesthesia.
Participants will be observed in one of three exposure groups based on routine perioperative practice and parental preference: children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll use. No intervention will be assigned by the investigators, and standard perioperative care will be maintained for all participants.
Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and just before anesthesia induction (T3). Anxiety levels will be evaluated using the modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
As a biochemical marker of stress response, serum cortisol levels will be measured from an additional blood sample obtained during routine intravenous cannulation performed for clinical purposes. No additional invasive procedures will be required for study-related assessments.
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale (PAED) at three points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2).
The study aims to provide clinical evidence regarding the potential role of non-pharmacological, easily applicable strategies such as doll use in reducing perioperative anxiety and postoperative delirium in pediatric surgical patients.
- Being tested
- Hospital-Provided Doll, Personal Doll, No Doll
- Keywords
- Preoperative Anxiety, Emergence Delirium, Pediatric Anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-Provided DollOther
Also called Hospital
Participants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice.
Personal DollOther
Participants will be accompanied by their own personal doll during the preoperative period based and routine practice.
No DollOther
Also called Control
Participants will undergo the surgical process without the use of any doll.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-Provided Doll Group | Participants in this cohort will consist of preschool children accompanied by a hospital-provided doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be assessed as part of routine perioperative observation. Receives: Other: Hospital-Provided Doll | |
| Personal Doll Group | Participants in this cohort will consist of preschool children accompanied by their own personal doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be evaluated using standardized assessment tools. Receives: Other: Personal Doll | |
| No Doll (Control) Group | Participants in this cohort will consist of preschool children who will undergo the surgical process without the use of any doll. Preoperative anxiety, serum cortisol levels, and postoperative emergence delirium will be observed and recorded for comparison purposes. Receives: Other: No Doll |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Level
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.
Measured: Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3)
Secondary outcomes (1)
Postoperative Emergence Delirium
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale (PAED; total score range 0-20). A score ≥10 will be considered indicative of emergence delirium, with higher scores reflecting greater severity.
Measured: Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Kaya, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403773
- Sponsor's protocol ID
- TABED 1-26-2055
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including demographic characteristics, group assignment, preoperative anxiety scores, and postoperative emergence delirium scores will be shared.
Publications
Vakili R, Feizi R, Salimi Y, Mottahedi M, Rizevandi P. Play dough or balloon blowing? A clinical trial comparing creative interventions for reducing preoperative anxiety in children aged 4-8 years. BMC Pediatr. 2025 May 15;25(1):384. doi: 10.1186/s12887-025-05718-1.
PubMed 40375092Llerena GE, Krzykwa E, Huzior M, Vilar N, Donahue D, Zisling H, Zielinski P, Shah N, Lewandowski T, Dennison S, Alonso N. Exploring Novel Non-pharmacologic Approaches to Address Preoperative Anxiety and Postoperative Pain in Pediatric Patients Undergoing In-Patient Surgical Procedures: A Scoping Review. Cureus. 2024 Jan 10;16(1):e52006. doi: 10.7759/cureus.52006. eCollection 2024 Jan.
PubMed 38344516Chamberland C, Bransi M, Boivin A, Jacques S, Gagnon J, Tremblay S. The effect of augmented reality on preoperative anxiety in children and adolescents: A randomized controlled trial. Paediatr Anaesth. 2024 Feb;34(2):153-159. doi: 10.1111/pan.14793. Epub 2023 Nov 4.
PubMed 37925608Ahmed AE, Daak LI, Alayidh MA, Filfilan RR, Alathath RM, Rehbini AA, Alshabrami TA, Alqahatani SA, Alzahrani RA, Althobaiti HS. The Role of Preoperative Virtual Reality for Anxiety Reduction in Pediatric Surgical Patients: A Systematic Review and Meta-Analysis. Cureus. 2025 Jan 7;17(1):e77077. doi: 10.7759/cureus.77077. eCollection 2025 Jan.
PubMed 39917152
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Personal Versus Hospital-Provided Dolls on Preoperative Anxiety and Postoperative Delirium in Preschool Children
- ClinicalTrials.gov ID
- NCT07403773
- Acronym / sponsor ID
- TABED 1-26-2055
- Keywords
- Preoperative Anxiety, Emergence Delirium, Pediatric Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 11 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.
The goal of this study is to evaluate the effects of personal versus hospital-provided dolls on preoperative anxiety and postoperative delirium in preschool children aged 3-7 years undergoing elective adenoidectomy and/or tonsillectomy.
The main questions it aims to answer are:
- Is the use of a personal doll or a hospital-provided doll associated with lower preoperative anxiety compared with no doll use?
- Is dolls used associated with a reduced incidence and severity of postoperative emergence delirium?
- Researchers will compare children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll to assess differences in preoperative anxiety levels, serum cortisol concentrations, and postoperative delirium scores.
Participants will:
- Be observed in one of three exposure groups (hospital-provided doll, personal doll, or no doll)
- Undergo standardized preoperative anxiety assessments at predefined time points
- Have serum cortisol levels measured during routine intravenous cannulation
- Be assessed for postoperative delirium in the recovery unit
Detailed description
This study is designed to evaluate the association between doll use and preoperative anxiety as well as postoperative emergence delirium in preschool children undergoing elective adenoidectomy and/or tonsillectomy. The study population consists of female children aged 3-7 years who meet the eligibility criteria and are scheduled for elective surgery under general anesthesia.
Participants will be observed in one of three exposure groups based on routine perioperative practice and parental preference: children accompanied by a hospital-provided doll, children accompanied by their personal doll, and children with no doll use. No intervention will be assigned by the investigators, and standard perioperative care will be maintained for all participants.
Preoperative anxiety will be assessed at four predefined time points: in the waiting area (T0), immediately before transfer to the operating room (T1), in the operating room corridor (T2), and just before anesthesia induction (T3). Anxiety levels will be evaluated using the modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A).
As a biochemical marker of stress response, serum cortisol levels will be measured from an additional blood sample obtained during routine intravenous cannulation performed for clinical purposes. No additional invasive procedures will be required for study-related assessments.
Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale (PAED) at three points: immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2).
The study aims to provide clinical evidence regarding the potential role of non-pharmacological, easily applicable strategies such as doll use in reducing perioperative anxiety and postoperative delirium in pediatric surgical patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hospital-Provided Doll Group | – | Other: Hospital-Provided DollParticipants in this cohort will consist of preschool children accompanied by a hospital-provided doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be assessed as part of routine perioperative observation. |
| Personal Doll Group | – | Other: Personal DollParticipants in this cohort will consist of preschool children accompanied by their own personal doll during the preoperative period. Preoperative anxiety levels, serum cortisol concentrations, and postoperative emergence delirium will be evaluated using standardized assessment tools. |
| No Doll (Control) Group | – | Other: No DollParticipants in this cohort will consist of preschool children who will undergo the surgical process without the use of any doll. Preoperative anxiety, serum cortisol levels, and postoperative emergence delirium will be observed and recorded for comparison purposes. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Female pediatric patients aged 3 to 7 years scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia.
Key inclusion criteria (5 listed)
- Female children aged 3-7 years
- Scheduled for elective adenoidectomy and/or tonsillectomy under general anesthesia
- Able to communicate verbally
- ASA physical status I or II, according to the American Society of Anesthesiologists classification
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (5 listed)
- Presence of psychiatric, neurological, or developmental disorders
- Presence of chronic pain or ongoing medical treatment that may affect anxiety levels
- Refusal to participate despite repeated encouragement by the investigators
- Use of additional anxiety-reducing methods or medications outside the study protocol prior to intervention
- Previous surgical experience
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 |
|---|---|---|
| Hospital-Provided DollAlso: HospitalParticipants will be accompanied by a hospital-provided doll during the preoperative period according to routine clinical practice. | Other | Hospital-Provided Doll Group |
| Personal DollParticipants will be accompanied by their own personal doll during the preoperative period based and routine practice. | Other | Personal Doll Group |
| No DollAlso: ControlParticipants will undergo the surgical process without the use of any doll. | Other | No Doll (Control) Group |
Primary outcome
Preoperative Anxiety Level
Time frame: Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3)
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS) and the Visual Analog Scale for Anxiety (VAS-A) during the preoperative period. Preoperative anxiety will be assessed using m-YPAS, (score range 23-100) and VAS-A (score range 0-10), with higher scores indicating increased anxiety severity.
1 secondary outcome
Postoperative Emergence Delirium
Time frame: Immediately after extubation (P0), upon admission to the post-anesthesia care unit (P1), and 30 minutes after admission (P2)
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 11 Feb 2026.
- Background: PubMed 40375092Vakili R, Feizi R, Salimi Y, Mottahedi M, Rizevandi P. Play dough or balloon blowing? A clinical trial comparing creative interventions for reducing preoperative anxiety in children aged 4-8 years. BMC Pediatr. 2025 May 15;25(1):384. doi: 10.1186/s12887-025-05718-1.
- Background: PubMed 38344516Llerena GE, Krzykwa E, Huzior M, Vilar N, Donahue D, Zisling H, Zielinski P, Shah N, Lewandowski T, Dennison S, Alonso N. Exploring Novel Non-pharmacologic Approaches to Address Preoperative Anxiety and Postoperative Pain in Pediatric Patients Undergoing In-Patient Surgical Procedures: A Scoping Review. Cureus. 2024 Jan 10;16(1):e52006. doi: 10.7759/cureus.52006. eCollection 2024 Jan.
- Background: PubMed 37925608Chamberland C, Bransi M, Boivin A, Jacques S, Gagnon J, Tremblay S. The effect of augmented reality on preoperative anxiety in children and adolescents: A randomized controlled trial. Paediatr Anaesth. 2024 Feb;34(2):153-159. doi: 10.1111/pan.14793. Epub 2023 Nov 4.
- Background: PubMed 39917152Ahmed AE, Daak LI, Alayidh MA, Filfilan RR, Alathath RM, Rehbini AA, Alshabrami TA, Alqahatani SA, Alzahrani RA, Althobaiti HS. The Role of Preoperative Virtual Reality for Anxiety Reduction in Pediatric Surgical Patients: A Systematic Review and Meta-Analysis. Cureus. 2025 Jan 7;17(1):e77077. doi: 10.7759/cureus.77077. eCollection 2025 Jan.
- Individual participant dataSharing planned: Yes. De-identified individual participant data including demographic characteristics, group assignment, preoperative anxiety scores, and postoperative emergence delirium scores will be shared.
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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.
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 Preoperative Anxiety and Emergence Delirium in Pediatric Anesthesia, run by Ankara City Hospital Bilkent 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 5 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 11 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 Filiz Kaya, M.D (+903125526000, filiz.kaya17@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Level (time frame: Waiting area (T0), immediately before transfer to the operating room (T1), operating room corridor (T2), and just before anesthesia induction (T3)). 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 NCT07403773, which also lists 4 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 11 Feb 2026.