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Effect of a PReoperative Information Video on Anxiety in Deep Brain Stimulation surgery patients

Effect of a PReoperative Information Video on Anxiety in Deep Brain Stimulation surgery patients - PRIVA-DBS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37791
Enrollment
40
Registered
2012-03-22
Start date
2012-08-08
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre-operatieve angst preoperative anxiety in Parkinson's disease patients

Interventions

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 show
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
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 participant

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Previous functional stereotactic neurosurgery

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)