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Not Yet Recruiting NCT07812272

Bookbased Emotion and Anxiety Reduction

Conditions: Pediatric Anesthesia, Pediatric Surgery, Perioperative Care, Perioperative Anxiety, Children Behavior

Sex: All
Ages: 4 Years – 10 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Insel Gruppe AG, University Hospital Bern

Location: Children's Hospital, Inselspital, University Hospital Bern Bern Canton of Bern

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07812272). StuddyBuddy aggregates publicly available trial information.