N/A
N=93
Educational Video and Peri-operative Anxiety
Ambulatory Surgical Procedures · Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03581097 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale) — 1.22; 1.02 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Video Group (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Geneva
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale) |
1.22; 1.02 | — |
| SECONDARY Degree of Satisfaction |
9.38; 9.5; 9.5; 9.5; 9.61; 9.51 | — |
| SECONDARY Vital Parameters 1: Arterial Blood Pressure |
139.36; 129.17; 81.69; 78.43 | — |
| SECONDARY Vital Parameters 2: Respiratory Rate |
14.71; 13.86 | — |
| SECONDARY Vital Parameters 3: Heart Rate |
75.45; 71.76 | — |
| SECONDARY First Subgroups Analyze: Anxious Patients |
135; 138; 83; 79 | — |
| SECONDARY Second Subgroups Analyze: Higher Anxiety Score |
129.36; 127.11; 78.21; 72.7 | — |
| SECONDARY Third Subgroup Analyze: First Experience With Surgery. |
132.65; 129.82; 80.8; 74.7 | — |
Summary
Preoperative anxiety is a common problem with an impact on surgical outcome, anaesthetic drug dosage and patient's satisfaction. An important component of preoperative anxiety is due to concerns related to anaesthesia. Appropriate patients information has been shown to reduce preoperative anxiety level and this can be effectively achieved through a video. The aim of this study is to assess the impact of an informative video about the anaesthesia technique on patient's preoperative anxiety levels before minor ambulatory procedures.
The study design is a prospective, randomized, controlled clinical trial, where we use of short patient educational video to reduce preoperative anxiety level, explaining all sequence of major events between the arrival in the operating room and the performance of anaesthesia.
Eligibility Criteria
Inclusion Criteria
- patients older than 18 years,
- American Society Anesthesiology (ASA) score I-III patients
- patients undergoing elective hand-surgery operation
- patients anesthetized by IntraVenous Regional Anesthesia (IVRA)
Exclusion Criteria
- patient refusal,
- on-going anxiolytic or anti-depressive therapy,
- diagnosis of anxiety or psychiatric disorders,
- general contraindications to IVRA,
- limited compliance
- language barriers
Data sourced from ClinicalTrials.gov (NCT03581097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.