Bookbased Emotion and Anxiety Reduction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorInsel Gruppe AG, University Hospital Bern

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Reading a childrens book to prepare for the surgery

    Other intervention

    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 intervention

    Children do not receive this book

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Reading the bookExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention

Trial outcomes

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).

Time frame
perioperative

Secondary outcomes

1

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
2

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
3

Demographics

Exploratory associations between preoperative anxiety and Age, Sex, Type of surgical procedure.

Time frame
Baseline
4

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

Other outcomes

Sponsors and contacts

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