Bookbased Emotion and Anxiety Reduction

NCT07812272 | Not Yet Recruiting

• 1 other identifier: BEAR-trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  perioperative

Secondary Outcomes (8)

• Baseline modified Yale Preoperative Anxiety Scale

  Baseline

• Anesthetic medication

  perioperative

• Demographics

  Baseline

• Postoperative delirium

  perioperative

• Parental anxiety

  Baseline

Study Arms (2)

Reading the book

EXPERIMENTAL

Children receive a book preoperatively that they read together with their parents

Other: Reading a childrens book to prepare for the surgery

Standard care

ACTIVE COMPARATOR

Children do not receive the book preoperatively

Other: Standard Care (in control arm)

Interventions

Reading a childrens book to prepare for the surgery OTHER

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.

Reading the book

Standard Care (in control arm) OTHER

Children do not receive this book

Standard care

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Children's Hospital, Inselspital, University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas Riva, Prof. Dr. med.

  Department of Anaesthesiology and Pain Medicine, Inselspital Bern, University Hospital, University of Bern

  STUDY CHAIR

Central Study Contacts

Viktoria A Pfeifle, Dr.med.

CONTACT

0041316643495; viktoria.pfeifle@insel.ch

Alexander Fuchs, PD Dr. med.

CONTACT

0041316322384; alexander.fuchs@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)