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

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).

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Sheffield teaching hospital NHS foundation trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Acupuncture at the Yintang point for 30 minutes.	Other: Acupuncture; Yintang point acupuncture
NO_INTERVENTION: Control; No intervention for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory Score	Patients completed the six item short form of the State-Trait Anxiety Inventory (STAI-S6) in order to assess baseline anxiety levels prior to any intervention. The STAI-S6 is a standardised short form of the 40-item Spielberger State-Trait Anxiety Inventory that has three anxiety-present and three anxiety-absent questions (Table 1). Scores from the STAI-S6 are prorated up to allow comparison with the full version of the questionnaire, with scores ranging from 20 (low anxiety) to 80 (high anxiety). The STAI-S6 has been shown to correlate well with the full version, [12] but is much quicker for participants to complete.	30 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amsterdam Preoperative Anxiety and Information Scale Scores	The Amsterdam Pre-operative Anxiety and Information Scale has four questions relating to anxiety (APAISa, Table 2) and has been shown to correlate well with the full version of the State-Trait Anxiety Inventory. The scores from the anxiety elements of the questionnaire are added together giving a possible of total score of 4 (low anxiety) to 20 (high anxiety).	30 minutes after intervention
Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)		Within 30 minutes of surgery
Incidence of Postoperative Nausea and Vomiting (PONV)		24 h postop
Pain Score in the Postanaesthetic Care Unit (PACU)	The number of patients experiencing moderate/severe pain in PACU.	Immediately postop
Pain Score		24 h postop

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Sheffield
• Investigators: Study Chair: Matthew D Wiles, BM BS FRCA, Consutant, Sheffield Teachinh Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (ESTIMATE): September 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: STH19048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO