Clinical trial NCT02561572: The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail
Official title: The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2015-09-28
Enrollment: 128
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 1. Methodology All patients presenting for neurosurgery will be considered and the study will take place on the Theatre Admissions Units at the Royal Hallamshire Hospital, Sheffield, United Kingdom. After gaining consent, baseline anxiety levels will be assessed using the APAIS and STAI questionnaires. The subject will then be randomised using a web-based programme to one of two groups: intervention (Yintang point), or control (no intervention). All the acupuncture will done with the same type of needle and by the same investigator. The questionnaires will be repeated 30 minutes later to assess the effect of the intervention.
2. Design: type of study design and justification The study is a randomised control trial looking at an acupuncture point utilised for anxiety reduction (Yintang), and a controls. The ratio of intervention to controls is 1:1. After advice for experts in acupuncture, the investigators are not including a placebo acupuncture intervention or sham acupuncture. This is because it is increasingly recognised that any form of acupuncture or acupressure can have central effects and that sham acupuncture is actually impossible to undertake. Pilot study data (awaiting publication) done in the investigator's institution demonstrated a mean (standard deviation) STAI score in neurosurgical patients of 8.86 (4.4). Previous data have suggested that acupuncture may reduce anxiety levels by 25-37%. Assuming a p\< 0.05 and power 0.9, in order to demonstrate a 30% reduction in STAI scores, the investigators will need 58 patients in each group. Assuming a 10% dropout rate, the investigators aim to recruit 64 patients in each group (128 in total). The investigators have shown that anxiety levels are not related to gender or site of surgery (cranial vs. spinal) and therefore will not stratify the groups. The investigators will undertake block randomisation to try and minimise any learning effects by the acupuncturist.
3. Analysis including statistical methods, where appropriate The investigators will use analysis of variance (ANOVA) to analyse anxiety scores from the two questionnaires (after testing for normality of data distribution). Pain scores will be analysed by t-tests and postoperative nausea and vomiting (PONV) incidence by Chi-squared.

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).

Primary outcomes:
measure: State-Trait Anxiety Inventory Score
timeFrame: 30 minutes after intervention
Secondary outcomes:
measure: Amsterdam Preoperative Anxiety and Information Scale Scores
timeFrame: 30 minutes after intervention
measure: Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)
timeFrame: Within 30 minutes of surgery
measure: Incidence of Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 h postop
measure: Pain Score in the Postanaesthetic Care Unit (PACU)
timeFrame: Immediately postop
measure: Pain Score
timeFrame: 24 h postop
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Consutant, Sheffield Teachinh Hospital NHS Foundation Trust
name: Matthew D Wiles, BM BS FRCA
role: STUDY_CHAIR
References: