Patient Anxiety Reduction in Children by Using Simple Explanation Videos
Primary Purpose
Perioperative Anxiety
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Treatment as usual + Video
Treatment as usual
Sponsored by
About this trial
This is an interventional supportive care trial for Perioperative Anxiety focused on measuring Anxiety, Video education, perioperative
Eligibility Criteria
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
Sites / Locations
- University Hospital Hamburg Eppendorf - Department of pediatric surgery
- The Altona Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as usual
Treatment as usual + Video
Arm Description
Treatment as Usual, Explanation of standard procedures before, during and after surgery by nurse
Treatment as usual and additionally Video
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)
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
Nurse reported anxiety before and after Intervention (T1 vs. T2)
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)
Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)
difference between anxiety levels, again separated in state and trait, reported by children, We use the State-Trait-Anxiety-Operation-Inventory
Evaluation of STOA in a pediatric cohort
Evaluation of Questionnaire in a pediatric cohort
Full Information
NCT ID
NCT04413773
First Posted
May 27, 2020
Last Updated
December 6, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT04413773
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Anxiety
Keywords
Anxiety, Video education, perioperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as Usual, Explanation of standard procedures before, during and after surgery by nurse
Arm Title
Treatment as usual + Video
Arm Type
Experimental
Arm Description
Treatment as usual and additionally Video
Intervention Type
Other
Intervention Name(s)
Treatment as usual + Video
Intervention Description
Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Explanation of standard procedures before, during and after surgery by nurse
Primary Outcome Measure Information:
Title
Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)
Description
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
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)
Description
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
Time Frame
Through study completion, an average of 1 year
Title
Nurse reported anxiety before and after Intervention (T1 vs. T2)
Description
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)
Time Frame
Through study completion, an average of 1 year
Title
Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)
Description
difference between anxiety levels, again separated in state and trait, reported by children, We use the State-Trait-Anxiety-Operation-Inventory
Time Frame
Through study completion, an average of 1 year
Title
Evaluation of STOA in a pediatric cohort
Description
Evaluation of Questionnaire in a pediatric cohort
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Trah, MD
Organizational Affiliation
Department of pediatric surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hamburg Eppendorf - Department of pediatric surgery
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
The Altona Children's Hospital
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
12. IPD Sharing Statement
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Patient Anxiety Reduction in Children by Using Simple Explanation Videos
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