Patient Anxiety Reduction in Children by Using Simple Explanation Videos

NCT04413773 | Completed

• 1 other identifier: VideoAnx2020
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Perioperative Anxiety

Keywords

Anxiety, Video education, perioperative

Outcome Measures

Primary Outcomes (1)

• Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)

  The primary endpoint was to analyze the preoperative state-anxiety in children before (t1) and after (t2) the intervention (video), compared with standard care (TAU). we use State-Trait-Anxiety-Operation-Inventory

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)

  Through study completion, an average of 1 year

• Nurse reported anxiety before and after Intervention (T1 vs. T2)

  Through study completion, an average of 1 year

• Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)

  Through study completion, an average of 1 year

• Evaluation of STOA in a pediatric cohort

  Through study completion, an average of 1 year

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

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

Other: Treatment as usual

Treatment as usual + Video

EXPERIMENTAL

Treatment as usual and additionally Video

Other: Treatment as usual + Video

Interventions

Treatment as usual + Video OTHER

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

Treatment as usual + Video

Treatment as usual OTHER

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

Treatment as usual

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• The surgical intervention must take place in one of the following body regions: thorax, abdomen and / or extremities (incl. Head and neck)
• A signed declaration of consent from the parents or legal guardians is available
• The patient has given a declaration of consent
• No mental illnesses may be diagnosed
• No chronic pre-existing conditions may be diagnosed
• Age of the patients is between 6 and 17 years

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (2)

University Hospital Hamburg Eppendorf - Department of pediatric surgery

Hamburg, 20246, Germany

Location

The Altona Children's Hospital

Hamburg, 22763, Germany

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutics; Videotape Recording

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Julian Trah, MD

  Department of pediatric surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

DE (2)