N/A
N=128
The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02561572 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: State-Trait Anxiety Inventory Score — 40.0; 43.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY State-Trait Anxiety Inventory Score |
40.0; 43.3 | — |
| SECONDARY Amsterdam Preoperative Anxiety and Information Scale Scores |
7; 8.5 | — |
| SECONDARY Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU) |
2; 1 | — |
| SECONDARY Incidence of Postoperative Nausea and Vomiting (PONV) |
— | — |
| SECONDARY Pain Score in the Postanaesthetic Care Unit (PACU) |
28; 21 | — |
| SECONDARY Pain Score |
— | — |
Summary
Preoperative anxiety has been associated with adverse consequences, including increased anaesthetic and analgesic requirements and overall dissatisfaction with care. Traditionally this has been treated with sedative drugs, such as benzodiazepines, but these can be associated with a sedative "hangover" with sedation continuing into the postoperative period. This is undesirable in patients undergoing neurosurgical procedures, as there is a need to assess neurological status in the immediate postoperative period. Acupuncture at the Yintang point (on the forehead between the eyebrows) has been shown to effectively reduce preoperative anxiety, but studies undertaken in the United Kingdom and neurosurgical population are lacking. The investigators aim to investigate the effect of acupuncture at the Yintang point on preoperative anxiety. Anxiety levels will be measured using two validated questionnaires: the State-Trait Anxiety Inventory (STAI) and Amsterdam Preoperative Anxiety and Information Scale (APAIS).
Eligibility Criteria
Inclusion Criteria
- Undergoing neurosurgical procedure under general anaesthesia
Exclusion Criteria
- pregnancy
- psychiatric disorders
- inability to provide own consent
- the use of sedative medication (benzodiazepines or sleeping tablets) in the 24 hours prior to surgery
- previous acupuncture experience
- any contraindication to the use of acupuncture such as bleeding disorders or skin inflammation/infection at the treatment sites
- use of preoperative acupuncture for other reasons (prevention of postoperative nausea and vomiting).
Data sourced from ClinicalTrials.gov (NCT02561572). 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.