- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413773
Patient Anxiety Reduction in Children by Using Simple Explanation Videos
Use of Simple Explanation Videos to Reduce Perioperative Patient Anxiety in Children.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hamburg, Germany, 20246
- University Hospital Hamburg Eppendorf - Department of pediatric surgery
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Hamburg, Germany, 22763
- The Altona Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- No signed declaration of consent from the parents or legal guardians available
- There is no signed declaration of consent from the patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as usual
Treatment as Usual, Explanation of standard procedures before, during and after surgery by nurse
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Explanation of standard procedures before, during and after surgery by nurse
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Experimental: Treatment as usual + Video
Treatment as usual and additionally Video
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Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)
Time Frame: Through study completion, an average of 1 year
|
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
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)
Time Frame: Through study completion, an average of 1 year
|
Secondary endpoint was to analyze the preoperative trait-anxiety in children, as well as the preoperative state- and trait-anxiety in the parental report.
We use the State-Trait-Anxiety-Operation-Inventory
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Through study completion, an average of 1 year
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Nurse reported anxiety before and after Intervention (T1 vs. T2)
Time Frame: Through study completion, an average of 1 year
|
we analyzed the nurse-reported anxiety status of the child before (t1) and after (t2) the intervention, we use a short State-Anxiety-Inventory (Krohne et al. 2005)
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Through study completion, an average of 1 year
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Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)
Time Frame: Through study completion, an average of 1 year
|
difference between anxiety levels, again separated in state and trait, reported by children, We use the State-Trait-Anxiety-Operation-Inventory
|
Through study completion, an average of 1 year
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Evaluation of STOA in a pediatric cohort
Time Frame: Through study completion, an average of 1 year
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Evaluation of Questionnaire in a pediatric cohort
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Through study completion, an average of 1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Julian Trah, MD, Department of Pediatric Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VideoAnx2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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