Patient Anxiety Reduction in Children by Using Simple Explanation Videos

NCT ID: NCT04413773

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-06-01

Brief Summary

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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

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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.

Conditions

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Perioperative Anxiety

Keywords

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Anxiety, Video education, perioperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment as usual

Treatment as Usual, Explanation of standard procedures before, during and after surgery by nurse

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Explanation of standard procedures before, during and after surgery by nurse

Treatment as usual + Video

Treatment as usual and additionally Video

Group Type EXPERIMENTAL

Treatment as usual + Video

Intervention Type OTHER

Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery

Interventions

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Treatment as usual + Video

Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery

Intervention Type OTHER

Treatment as usual

Explanation of standard procedures before, during and after surgery by nurse

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Julian Trah

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julian Trah, MD

Role: PRINCIPAL_INVESTIGATOR

Department of pediatric surgery

Locations

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University Hospital Hamburg Eppendorf - Department of pediatric surgery

Hamburg, , Germany

Site Status

The Altona Children's Hospital

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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VideoAnx2020

Identifier Type: -

Identifier Source: org_study_id