Our aim is to investigate whether patients who are informed by video will have less preoperative anxiety than the patients who receive usual information.
ID
Source
Brief title
Condition
- Other condition
- Movement disorders (incl parkinsonism)
- Nervous system, skull and spine therapeutic procedures
Synonym
Health condition
pre-operatieve angst
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the change scores on the Spielberger State Trait
Anxiety Inventory (STAI) between the intervention group and the control group
at different time points.
Secondary outcome
- Visual analogue scale (VAS) is a validated instrument for measuring anxiety.
- The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a
six-item questionnaire to assess patients* anxiety level and information
requirement in the preoperative phase.
Background summary
Parkinson*s disease (PD) patients benefit from Deep Brain Stimulation (DBS).
DBS is a surgical treatment used to treat the motor symptoms of PD. A large
part of the surgery is performed while the patient has local anaesthesia.
Altogether the surgery takes about eight hours and is a profound experience for
patients, since they are awake during most parts of the surgery.
Preoperative anxiety is common in surgical patients, with an incidence of 60 to
92%. In neurosurgical patients an incidence of preoperative anxiety of 89% is
reported. There is no information available on incidence and severity of
preoperative anxiety in patients undergoing DBS surgery. Previous studies about
preoperative anxiety have shown that preoperative fears are most commonly
related to questions of whether the surgery will be effective, whether there is
postoperative pain, and whether there is fear for being awake during surgery.
The effect of preoperative multimedia information on anxiety was measured in
patients undergoing surgical procedures of the arm or leg under regional
anaesthesia, but we consider this to be different as compared to DBS surgery.
Currently, DBS surgery patients receive a lot of information before their
operation in the AMC. They get information leaflets and several educational
interviews. Despite these efforts, we notice that patients still have a lot of
questions before surgery and that they are very tense. This is why improvement
of the information procedure is needed. We want to investigate the effect of an
informative video on preoperative and perioperative anxiety.
Study objective
Our aim is to investigate whether patients who are informed by video will have
less preoperative anxiety than the patients who receive usual information.
Study design
The study is an open-label randomized controlled trial. The trial is carried
out in the Academical Medical Center Amsterdam (AMC). Patients will be followed
over a period of three months.
Intervention
Information video
Patients are randomly allocated to the intervention group (watching the video
and standard care) or a control group (standard care).
A video explaining every step of surgery is shown to patients participating in
the intervention group. This video includes a description of the stereotactic
frame, MRI-scan, surgical procedure, risks involved; including the risks of
brain hemorrhage (1-2%) and infection (5%). It also provides information about
the postoperative procedures, postoperative setting of stimulation and visits
to the outpatient clinic. After this video there is time for patients to ask
questions and more explanation of items that are addressed in the video.
Patients can take the video home to watch it and show it to their family and/or
friends.
The control group receives standard care; standard information by a DBS nurse
and neurologist. This also includes a description of the stereotactic frame,
MRI-scan, the surgical procedure, risks and (side) effects involved. The
participants also get information leaflets to read.
Study burden and risks
For this study, participants have to fill in questionnaires and the
intervention group patients will watch an extra video. We consider that the
chance of increasing anxiety due to the study procedures (e.g., video,
questionnaires about anxiety) is small. If this trial confirms our hypothesis,
patients will be less anxious in the future. Therefore we consider the risks
and burden for the patient to be well in proportion to the potential value for
the enrolled patients.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Parkinson's disease patients planned for DBS surgery;
The patient is able to communicate adequately in Dutch;
The patient is 18 years or older
Exclusion criteria
Previous functional stereotactic neurosurgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL38657.018.11 |