Pediatric AnesthesiaBEARNCT07812272
Bookbased Emotion and Anxiety Reduction
A study testing Reading a childrens book to prepare for the surgery in people with Pediatric Anesthesia and Pediatric Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Many children are afraid of surgery and anesthesia. Studies show that up to 60% of children experience significant anxiety before a scheduled procedure. This fear is caused, for example, by the unfamiliar hospital environment, separation from parents, worry about pain, or because they do not know exactly what will… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pediatric Anesthesia, Pediatric Surgery, Perioperative Care
- What is being tested?
- Reading a childrens book to prepare for the surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2026to Apr 2028
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 10 years at the time of surgery
- Scheduled for elective surgical intervention (inguinal hernia, umbilical hernia, epigastric or supraumbilical hernia)
- Understanding of the German language
- Written informed consent obtained from at least one parent or legal guardian
Who cannot join
- Emergency surgical procedures
- History of previous surgery
- Less than 7 days between randomization and surgical procedure
- Known developmental delay, cognitive impairment, or psychiatric disorder that may interfere with anxiety assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Children's Hospital, Inselspital, University Hospital Bern
Bern, Canton of Bern, 3010
Viktoria A Pfeifle, Dr. med., 0041316643495, viktoria.pfeifle@insel.ch
Alexander Fuchs, PD Dr. med., 0041316322384, alexander.fuchs@insel.ch
About this study
Official title: Bookbased Emotion and Anxiety Reduction: A Children's Storybook Intervention to Reduce Preoperative Fear, a Single-center Prospective Randomized Controlled Trial
Many children are afraid of surgery and anesthesia. Studies show that up to 60% of children experience significant anxiety before a scheduled procedure. This fear is caused, for example, by the unfamiliar hospital environment, separation from parents, worry about pain, or because they do not know exactly what will happen. Severe anxiety before surgery can complicate the procedure and is linked to higher stress, increased post-operative pain perception, and behavioral changes. This study investigates whether a specially developed, age-appropriate children's book can help reduce anxiety before surgery. The book explains the anesthesia and surgical procedure in a child-friendly way using pictures and simple text. Children aged 4 to 10 who are undergoing surgery at the Inselspital Bern for an inguinal, umbilical, or ventral hernia can participate. A total of 50 children are to be included. The children will be randomly divided into two groups: One group receives the children's book to prepare at home. The other group receives the usual preparation without the book. The children's anxiety is measured using an established observation scale - once during the preliminary examination and again on the day of surgery before anesthesia. In addition, several contributing factors are recorded, such as how well the child cooperates during the induction of anesthesia or how much anesthetic medication is required. Parents will complete a short questionnaire regarding their own anxiety. Participation involves minimal risk. Only a children's book is provided, and the children's behavior is observed. No additional medical interventions are planned. The aim of the study is to test whether a simple, cost-effective, and easily implementable tool - a children's book - can effectively reduce anxiety before surgery. If the book proves to be helpful, it could be routinely used to prepare children for surgery in the future.
Read the detailed description
Background and Rationale:
Many children experience significant anxiety before scheduled surgical procedures. Literature indicates that up to 60% of pediatric patients exhibit substantial preoperative anxiety. This fear is primarily driven by an unfamiliar hospital environment, separation from parents, anticipation of pain, and a lack of understanding regarding the upcoming procedures. High levels of preoperative anxiety can complicate the clinical workflow, increase patient stress, elevate post-operative pain perception, and lead to negative postoperative behavioral changes. This study investigates whether a specially designed, age-appropriate children's book can effectively reduce preoperative anxiety. The educational book utilizes pictures and simplified language to explain the processes of anesthesia and surgery in a child-friendly manner.
Study Design and Objectives: This is a randomized controlled trial aiming to evaluate the efficacy of an educational children's book as a low-threshold intervention to mitigate preoperative anxiety in pediatric patients. The primary objective is to assess whether introducing this book during home preparation significantly decreases anxiety scores compared to standard care.
Participant Enrollment and Randomization: The study aims to enroll a total of 50 pediatric patients. Eligible participants are children aged 4 to 10 years scheduled for elective surgery (inguinal, umbilical, or ventral hernia repair) at the Inselspital Bern. Upon enrollment, participants will be randomly allocated into one of two parallel groups:
Intervention Group: Participants receive the specialized children's book for preoperative preparation at home.
Control Group: Participants receive standard preoperative preparation without the educational book.
Data Collection and Outcomes: Children's anxiety levels will be measured using an established, validated observational scale. Assessments will take place at two time points: during the initial preliminary outpatient examination (baseline) and on the day of surgery prior to the induction of anesthesia. Secondary outcomes and confounding variables will also be recorded, including:
The child's level of cooperation during the induction of anesthesia. The total dosage of anesthetic medication required. Parental anxiety levels, measured via a brief self-reported questionnaire.
Risk Assessment: Participation in this study carries minimal risk. The intervention consists solely of providing an educational book and observing standard clinical and behavioral outcomes. No additional medical interventions, invasive procedures, or alterations to the standard surgical protocol are involved.
Significance: If the intervention proves successful, this educational tool could be implemented into routine clinical practice to improve preoperative preparation and emotional well-being for pediatric surgical patients
- Conditions
- Pediatric Anesthesia, Pediatric Surgery, Perioperative Care, Perioperative Anxiety, Children Behavior
- Being tested
- Reading a childrens book to prepare for the surgery, Standard Care (in control arm)
- Keywords
- Can a book reduce preoperative anxiety in children?, book based emotion an anxiety relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading a childrens book to prepare for the surgeryOther
A book that has been especially designed for this study, a children's story, that could prepare children before undergoing surgery will be handed out to the children and their caregivers. They should read it before surgery.
Standard Care (in control arm)Other
Children do not receive this book
| Study group | Role | What they receive |
|---|---|---|
| Reading the book | Experimental | Children receive a book preoperatively that they read together with their parents Receives: Other: Reading a childrens book to prepare for the surgery |
| Standard care | Active comparator | Children do not receive the book preoperatively Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Yale Preoperative Anxiety Scale
Preoperative anxiety level on the day of surgery, measured using the modified Yale Preoperative Anxiety Scale (mYPAS), assessed prior to induction of anesthesia before administration of any sedative premedication.
The mYPAS Scale ranges from 23,33 (minimum) to 100 (maximum), with higher scores indicating greater preoperative anxiety. The scale comprises 22 items across 5 behavioral categories (activity, vocalization, emotional expressivity, state of apparent arousal, use of parents).
Measured: perioperative
Secondary outcomes (8)
Baseline modified Yale Preoperative Anxiety Scale
Baseline preoperative anxiety level measured using the modified Yale Preoperative Anxiety (mYPAS) scale prior to any study-related intervention. The mYPAS Scale ranges from 23,33 (minimum) to 100 (maximum), with higher scores indicating greater preoperative anxiety. The scale comprises 22 items across 5 behavioral categories (activity, vocalization, emotional expressivity, state of apparent arousal, use of parents).
Measured: Baseline
Anesthetic medication
Amount of anesthetic medication used for induction of anesthesia, recorded from the anesthesia record. The amount of anesthetic medication used for induction will be analyzed descriptively and exploratorily; no causal inference is planned.
Measured: perioperative
Demographics
Exploratory associations between preoperative anxiety and Age, Sex, Type of surgical procedure.
Measured: Baseline
Postoperative delirium
Incidence of Postoperative delirium will be assessed in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium (PAED) scale by trained clinical staff and analyzed exploratorily. The PAED scale ranges from 0 (minimum) to 20 (maximum). Higher total scores indicate more severe emergence delirium.
Measured: perioperative
Parental anxiety
Parental anxiety assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7) prior to intervention. The GAD-7 is a validated questionnaire widely used to quantify anxiety symptoms in adults. The GAD-7 ranges from 0 (minimum) to 21 (maximum). The higher the score, the more anxiety.
Measured: Baseline
Child compliance during induction (Induction Compliance Checklist)
Child compliance during anesthesia induction, assessed using the Induction Compliance Checklist (ICC), a behavioral compliance scale during induction of anesthesia. This observational measure captures negative or non-compliant behaviors during anesthesia induction and provides complementary information on perioperative distress and cooperation. The Induction Compliance Checklist ranges from 0 (minimum) to 10 (maximum). Higher scores indicate poorer compliance during induction. Lower scores indicate better cooperation.
Measured: perioperative
Parental educational level and age
Age of the parents and parental educational level, categorized according to the Swiss education system (primary, secondary I, secondary II, tertiary)
Measured: Baseline
Acceptability of the book intervention using a questionnaire
Acceptability of the intervention assessed descriptively using parental feedback by using a questionnaire.
Measured: postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Riva, Prof. Dr. med., Study chair, Department of Anaesthesiology and Pain Medicine, Inselspital Bern, University Hospital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812272
- Sponsor's protocol ID
- BEAR-trial
- Acronym
- BEAR
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bookbased Emotion and Anxiety Reduction: A Children's Storybook Intervention to Reduce Preoperative Fear, a Single-center Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07812272
- Acronym / sponsor ID
- BEAR / BEAR-trial
- Conditions
- Pediatric Anesthesia, Pediatric Surgery, Perioperative Care, Perioperative Anxiety, Children Behavior
- Keywords
- Can a book reduce preoperative anxiety in children?, book based emotion an anxiety relief
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Sep 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.
Many children are afraid of surgery and anesthesia. Studies show that up to 60% of children experience significant anxiety before a scheduled procedure. This fear is caused, for example, by the unfamiliar hospital environment, separation from parents, worry about pain, or because they do not know exactly what will happen. Severe anxiety before surgery can complicate the procedure and is linked to higher stress, increased post-operative pain perception, and behavioral changes. This study investigates whether a specially developed, age-appropriate children's book can help reduce anxiety before surgery. The book explains the anesthesia and surgical procedure in a child-friendly way using pictures and simple text. Children aged 4 to 10 who are undergoing surgery at the Inselspital Bern for an inguinal, umbilical, or ventral hernia can participate. A total of 50 children are to be included. The children will be randomly divided into two groups: One group receives the children's book to prepare at home. The other group receives the usual preparation without the book. The children's anxiety is measured using an established observation scale - once during the preliminary examination and again on the day of surgery before anesthesia. In addition, several contributing factors are recorded, such as how well the child cooperates during the induction of anesthesia or how much anesthetic medication is required. Parents will complete a short questionnaire regarding their own anxiety. Participation involves minimal risk. Only a children's book is provided, and the children's behavior is observed. No additional medical interventions are planned. The aim of the study is to test whether a simple, cost-effective, and easily implementable tool - a children's book - can effectively reduce anxiety before surgery. If the book proves to be helpful, it could be routinely used to prepare children for surgery in the future.
Detailed description
Background and Rationale:
Many children experience significant anxiety before scheduled surgical procedures. Literature indicates that up to 60% of pediatric patients exhibit substantial preoperative anxiety. This fear is primarily driven by an unfamiliar hospital environment, separation from parents, anticipation of pain, and a lack of understanding regarding the upcoming procedures. High levels of preoperative anxiety can complicate the clinical workflow, increase patient stress, elevate post-operative pain perception, and lead to negative postoperative behavioral changes. This study investigates whether a specially designed, age-appropriate children's book can effectively reduce preoperative anxiety. The educational book utilizes pictures and simplified language to explain the processes of anesthesia and surgery in a child-friendly manner.
Study Design and Objectives: This is a randomized controlled trial aiming to evaluate the efficacy of an educational children's book as a low-threshold intervention to mitigate preoperative anxiety in pediatric patients. The primary objective is to assess whether introducing this book during home preparation significantly decreases anxiety scores compared to standard care.
Participant Enrollment and Randomization: The study aims to enroll a total of 50 pediatric patients. Eligible participants are children aged 4 to 10 years scheduled for elective surgery (inguinal, umbilical, or ventral hernia repair) at the Inselspital Bern. Upon enrollment, participants will be randomly allocated into one of two parallel groups:
Intervention Group: Participants receive the specialized children's book for preoperative preparation at home.
Control Group: Participants receive standard preoperative preparation without the educational book.
Data Collection and Outcomes: Children's anxiety levels will be measured using an established, validated observational scale. Assessments will take place at two time points: during the initial preliminary outpatient examination (baseline) and on the day of surgery prior to the induction of anesthesia. Secondary outcomes and confounding variables will also be recorded, including:
The child's level of cooperation during the induction of anesthesia. The total dosage of anesthetic medication required. Parental anxiety levels, measured via a brief self-reported questionnaire.
Risk Assessment: Participation in this study carries minimal risk. The intervention consists solely of providing an educational book and observing standard clinical and behavioral outcomes. No additional medical interventions, invasive procedures, or alterations to the standard surgical protocol are involved.
Significance: If the intervention proves successful, this educational tool could be implemented into routine clinical practice to improve preoperative preparation and emotional well-being for pediatric surgical patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reading the book | Experimental | Other: Reading a childrens book to prepare for the surgeryChildren receive a book preoperatively that they read together with their parents |
| Standard care | Active comparator | Other: Standard Care (in control arm)Children do not receive the book preoperatively |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4 to 10 years at the time of surgery
- Scheduled for elective surgical intervention (inguinal hernia, umbilical hernia, epigastric or supraumbilical hernia)
- Understanding of the German language
- Written informed consent obtained from at least one parent or legal guardian
Key exclusion criteria (4 listed)
- Emergency surgical procedures
- History of previous surgery
- Less than 7 days between randomization and surgical procedure
- Known developmental delay, cognitive impairment, or psychiatric disorder that may interfere with anxiety assessment
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 |
|---|---|---|
| Reading a childrens book to prepare for the surgeryA book that has been especially designed for this study, a children's story, that could prepare children before undergoing surgery will be handed out to the children and their caregivers. They should read it before surgery. | Other | Reading the book |
| Standard Care (in control arm)Children do not receive this book | Other | Standard care |
Primary outcome
modified Yale Preoperative Anxiety Scale
Time frame: perioperative
Preoperative anxiety level on the day of surgery, measured using the modified Yale Preoperative Anxiety Scale (mYPAS), assessed prior to induction of anesthesia before administration of any sedative premedication. The mYPAS Scale ranges from 23,33 (minimum) to 100 (maximum), with higher scores indicating greater preoperative anxiety. The scale comprises 22 items across 5 behavioral categories (activity, vocalization, emotional expressivity, state of apparent arousal, use of parents).
8 secondary outcomes
Baseline modified Yale Preoperative Anxiety Scale
Time frame: Baseline
Anesthetic medication
Time frame: perioperative
Demographics
Time frame: Baseline
Postoperative delirium
Time frame: perioperative
Parental anxiety
Time frame: Baseline
Child compliance during induction (Induction Compliance Checklist)
Time frame: perioperative
Parental educational level and age
Time frame: Baseline
Acceptability of the book intervention using a questionnaire
Time frame: postoperative
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Thomas Riva, Prof. Dr. med. study chair
Department of Anaesthesiology and Pain Medicine, Inselspital Bern, University Hospital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading a childrens book to prepare for the surgery in people with Pediatric Anesthesia and Pediatric Surgery, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 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: opening soon, as of the sponsor's last update on 10 Sep 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 Switzerland. 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 Viktoria A Pfeifle, Dr.med. (0041316643495, viktoria.pfeifle@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Yale Preoperative Anxiety Scale (time frame: perioperative). 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 10 Sep 2026.