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NOT YET RECRUITING
NCT07812272
NA

Bookbased Emotion and Anxiety Reduction

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

Official title: Bookbased Emotion and Anxiety Reduction: A Children's Storybook Intervention to Reduce Preoperative Fear, a Single-center Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

4 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-11-01

Completion Date

2028-04

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

OTHER

Reading a childrens book to prepare for the surgery

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.

OTHER

Standard Care (in control arm)

Children do not receive this book

Locations (1)

Children's Hospital, Inselspital, University Hospital Bern

Bern, Canton of Bern, Switzerland