Clinical trial NCT04413773: Patient Anxiety Reduction in Children by Using Simple Explanation Videos
Official title: Use of Simple Explanation Videos to Reduce Perioperative Patient Anxiety in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Anxiety
Keywords: Anxiety, Video education, perioperative
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 94
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The reduction of preoperative anxiety in children and adolescents before an elective surgical procedure is an important clinical question in perioperative care. Adequate, age-appropriate patient information about the processes of the inpatient stay plays an important role in order to address possible worries and fears to reduce.

The medium video is popular with children and adolescents today and offers the possibility of an easily understandable and vivid presentation of information.

Detailed description: Studies by the health insurance companies, scientific publications and economic papers show that in times of increasing economic interests of the hospitals and the resulting necessity of economic working methods in the medical system, less time remains for human interaction. This creates areas of conflict, such as the patient's right to information regarding the time available to medical personnel. This in turn leads to significant stress factors in patients who are involved in the treatment and mostly on the communication level, such as "Missing information", "misunderstood visit", "missing partnership relationship" refer to what is reflected in patient satisfaction and fears. Studies show how important good perioperative psychosocial care is for reducing these circumstances in children, also and especially in the context of further development. The drug options for calming and reducing anxiety are already known, but there are also increasing numbers of non-drug approaches to reducing anxiety and stress in the literature. Painting therapy and clinic clowns are examples. However, access to such resources is limited and costs are permanently high. New technologies, e.g. mobile phones and tablets, with the associated media, increasingly finding their way into our society, are now inexpensive to buy and have become an integral part of most households. Such devices and media are increasingly used in clinical studies and patient care. Their use is tested extensively in modern medicine, e.g. to avoid unnecessary postoperative consultations in the emergency room or to increase cognitive learning for children. Even small children can use and understand these media early on. Videos are one of the most common media already understood by the smallest patients.

Eligibility criteria: Inclusion Criteria:

1. All patients (children) who present themselves planned in the Altona Children's Hospital or in the University Clinic Hamburg Eppendorf in the course of an upcoming elective operation.
2. The surgical intervention must take place in one of the following body regions: thorax, abdomen and / or extremities (incl. Head and neck)
3. A signed declaration of consent from the parents or legal guardians is available
4. The patient has given a declaration of consent
5. No mental illnesses may be diagnosed
6. No chronic pre-existing conditions may be diagnosed
7. Age of the patients is between 6 and 17 years

Exclusion Criteria:

1. No signed declaration of consent from the parents or legal guardians available
2. There is no signed declaration of consent from the patient

Primary outcomes:
measure: Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)
timeFrame: Through study completion, an average of 1 year
measure: Nurse reported anxiety before and after Intervention (T1 vs. T2)
timeFrame: Through study completion, an average of 1 year
measure: Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of STOA in a pediatric cohort
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg Eppendorf - Department of pediatric surgery
city: Hamburg
country: Germany
facility: The Altona Children's Hospital
Study officials:
affiliation: Department of pediatric surgery
name: Julian Trah, MD
role: PRINCIPAL_INVESTIGATOR
References: