An interventional study of Reading a childrens book to prepare for the surgery and Standard Care (in control arm) in Pediatric Anesthesia, Pediatric Surgery and Perioperative Care, sponsored by Insel Gruppe AG, University Hospital Bern. Not yet recruiting at 1 site in Switzerland. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
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
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children receive a book preoperatively that they read together with their parents
Other: Reading a childrens book to prepare for the surgery
Children do not receive the book preoperatively
Other: Standard Care (in control arm)
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.
Children do not receive this book
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).
Time frame: perioperative
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).
Time frame: 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.
Time frame: perioperative
Demographics
Exploratory associations between preoperative anxiety and Age, Sex, Type of surgical procedure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Baseline
Acceptability of the book intervention using a questionnaire
Acceptability of the intervention assessed descriptively using parental feedback by using a questionnaire.
Time frame: postoperative
Plan to share: No
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Insel Gruppe AG, University Hospital Bern →