Perioperative AnxietyNCT04413773
Patient Anxiety Reduction in Children by Using Simple Explanation Videos
A study testing Treatment as usual + Video and Treatment as usual in people with Perioperative Anxiety, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Perioperative Anxiety
- What is being tested?
- Treatment as usual + Video and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Sep 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- No signed declaration of consent from the parents or legal guardians available
- There is no signed declaration of consent from the patient
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Hamburg Eppendorf - Department of pediatric surgery
Hamburg, 20246
The Altona Children's Hospital
Hamburg, 22763
About this study
Official title: 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.
Read the 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.
- Conditions
- Perioperative Anxiety
- Being tested
- Treatment as usual + Video, Treatment as usual
- Keywords
- Anxiety, Video education, perioperative
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual + VideoOther
Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery
Treatment as usualOther
Explanation of standard procedures before, during and after surgery by nurse
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Treatment as Usual, Explanation of standard procedures before, during and after surgery by nurse Receives: Other: Treatment as usual |
| Treatment as usual + Video | Experimental | Treatment as usual and additionally Video Receives: Other: Treatment as usual + Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
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
Measured: Through study completion, an average of 1 year
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)
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
Evaluation of STOA in a pediatric cohort
Evaluation of Questionnaire in a pediatric cohort
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Sep 2019
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnxietyStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Julian Trah, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Julian Trah, MD, Principal investigator, Department of pediatric surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413773
- Sponsor's protocol ID
- VideoAnx2020
- Status last verified
- Dec 2021
- First submitted
- 27 May 2020
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Simple Explanation Videos to Reduce Perioperative Patient Anxiety in Children.
- ClinicalTrials.gov ID
- NCT04413773
- Acronym / sponsor ID
- VideoAnx2020
- Conditions
- Perioperative Anxiety
- Keywords
- Anxiety, Video education, perioperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Treatment as usualTreatment as Usual, Explanation of standard procedures before, during and after surgery by nurse |
| Treatment as usual + Video | Experimental | Other: Treatment as usual + VideoTreatment as usual and additionally Video |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- No signed declaration of consent from the parents or legal guardians available
- There is no signed declaration of consent from the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usual + VideoAdditionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery | Other | Treatment as usual + Video |
| Treatment as usualExplanation of standard procedures before, during and after surgery by nurse | Other | Treatment as usual |
Primary outcome
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
4 secondary outcomes
Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)
Time frame: Through study completion, an average of 1 year
Nurse reported anxiety before and after Intervention (T1 vs. T2)
Time frame: Through study completion, an average of 1 year
Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)
Time frame: Through study completion, an average of 1 year
Evaluation of STOA in a pediatric cohort
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Trah, MD principal investigator
Department of pediatric surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual + Video and Treatment as usual in people with Perioperative Anxiety, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.