The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail

Anxiety Clinical Trial

Official title:

The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02561572
• Other study ID #: STH19048
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2015
• Last updated: November 16, 2015
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: Jena Mamdani
• Phone: 00441142712381
• Email: jmamdani1[@]sheffield.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Acupuncture
Yintang point acupuncture

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospital NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Inventory score		30 minutes after intervention	No
Secondary	Amsterdam Preoperative Anxiety and Information Scale scores		30 minutes after intervention	No
Secondary	Incidence of postoperative nausea and vomiting (PONV) in the postanaesthetic care unit (PACU)		Immediately postop	No
Secondary	Incidence of postoperative nausea and vomiting (PONV)		24 h postop	No
Secondary	Pain score in the postanaesthetic care unit (PACU)		Immediately postop	No
Secondary	Pain score		24 h postop	No