HappyMed in the Hospital; Will the use of the HappyMed (a portable multimedia system) during an orthopedic operation with local anaesthesia lead to reduced stress for the patient?

Completed

• Conditions: Anxiety and Stress; 10005944

• Registration Number: NL-OMON50193
• Lead Sponsor: AMC chirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

* Individuals to be scheduled for the following operations with a deemed
surgical operation time of at least 30 minutes, under regional anesthetics :
- All procedures of the lower extrimities including: Anterior ankle
arthroscopy(including cartilage and impingement procedures), Posterior ankle
arthroscopy, Knee arthroscopy (including cartilage, meniscus lesions and
anterior cruciate ligament procedures)
* Aged 18 years or older

Exclusion Criteria

* Individuals with a known history of panic attacks, phobias, anxiety or
borderline disorders as reported by patient in history taking or from patient
files
* Individuals not being able to understand Dutch language at primary school
level
* Individuals not being able to read or write Dutch
* Individuals with a known history of known hyper- or hypotensia
* Individuals with a history of loss of central or pheripheric field of vision
on either eye
* Individuals with a history of either conductive, sensorineural or mixed
hearing loss
* Individuals with refraction anomaly on either eye or both eyes, wearing
glasses
* Individuals wearing hearing devices on either ear
* Individuals on any kind of antihypertensic medication
* Individuals using any kind of prescribed or non-prescribed pain medication
* Individuals on any kind of anti-arrhythmic medication
* Individuals with a known history of alcohol, drug, and/or psychiatric
problems
* Individuals who are unable to sign informed consent owing to mental disorder
or formally stated to be incompentent to decide
* Individuals not willing or being able to sign informed consent for the
proposed study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Stress level measured with the STAI 6 questionnaire<br /><br>-Bloodpressure<br /><br>-Heart rate<br /><br>- Painscore measured with the VAS-score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>