To assess if the use of videoglasses can lead to more anxiety reduction than hearing preferred audio in patients undergoing surgical procedures under local anesthesia.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Stress level measured with the STAI 6 questionnaire
-Bloodpressure
-Heart rate
- Painscore measured with the VAS-score
Secondary outcome
N/A
Background summary
Patients 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.
The pilotstudy will be conducted in the OK-daycare of the Academic medical
centre in Amsterdam
Study objective
To assess if the use of videoglasses can lead to more anxiety reduction than
hearing preferred audio in patients undergoing surgical procedures under local
anesthesia.
Study design
Randomized Clinical Trial
the patients are divided in two groups at random. The intervention group is
offered the videoglasses with a scenic and relaxing wildlife/nature movie, the
control group is offered preferred type of relaxing audio.
Both groups have to complete the validated questionaire about stress(STAI6) and
score their pain with the VAS before and after surgery
During the operation the mean blood pressure and mean heart rate are measured
by both groups
Intervention
The 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.
Study burden and risks
Patients are asked to complete questoinnaires investigating anxiety / stress
(the STAI 6) and pain (VAS score analogue scale). This wil take about 30-60
minutes. The bloodpressure and heart ratings will be measured troughout the
operation and recovery period, as is customary procedure (no extra burden of
discomfort for the patient).
Hasnerstraße 123
Wenen 1160
NL
Hasnerstraße 123
Wenen 1160
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56379.018.16 |
| OMON | NL-OMON19928 |