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van CCT (UK)

van CCT (UK)

HappyMed in the Hospital, use of videoglasses during surgery for anxiety reduction

- candidate number27452
- NTR NumberNTR6635
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jun-2017
- Secondary IDsNL56379.018.16 
- Public TitleHappyMed in the Hospital, use of videoglasses during surgery for anxiety reduction
- Scientific TitleHappyMed in the Hospital; Will the use of the HappyMed during an orthopedic operation with local anaesthesia lead to reduced stress for the patient?
- hypothesisThe use of videoglasses will lead to more anxiety reduction than hearing preferred audio in patients undergoing surgical procedures under local anesthesia.
- Healt Condition(s) or Problem(s) studiedAnxiety, Surgery, Local anesthesia
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-apr-2016
- planned closingdate20-apr-2018
- Target number of participants50
- InterventionsThe intervention group is offered the videoglasses with a scenic and relaxing wildlife/nature movie.
The control group will be hearing their preferred type of relaxing audio.
- Primary outcome-Stress level measured with the STAI 6 questionnaire
- Secondary outcome-Bloodpressure
-Heart rate
-Painscore measured with the VAS-score
- TimepointsPreoperative, peroperative, 15 min after sign out, 2 uur after sign out
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Government funding
- Publications
- Brief summaryPatients experience different levels of anxiety before, during and after a surgical operation. The perception of a certain operation will depend on the procedure itself but also on the levels of stress and anxiety a patient go through. To positively affect the experience of an operation we need to reduce the stress and anxiety a patient encounter during the process of an operation.

The 'HappyMed' video glasses is an innovative portable multimedia system which can be used during an operation to try to reduce the stress and anxiety levels of the patient. This could be achieved by watching and listening to a movie with the 'HappyMed' video glasses.

This research addresses the potential benefits of use of the ‘HappyMed’ videoglasses in terms of lowering anxiety and perceived pain in the outpatient setting during selected orthopedic procedures with an deemed operation time of at least 30 minutes.
- Main changes (audit trail)
- RECORD23-jun-2017 - 27-aug-2017

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