The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
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).
Sites / Locations
- Sheffield Teaching Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Acupuncture at the Yintang point for 30 minutes.
No intervention for 30 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)
Incidence of Postoperative Nausea and Vomiting (PONV)
Pain Score in the Postanaesthetic Care Unit (PACU)
The number of patients experiencing moderate/severe pain in PACU.
Pain Score
Full Information
NCT ID
NCT02561572
First Posted
September 25, 2015
Last Updated
February 1, 2017
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT02561572
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Sheffield
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Acupuncture at the Yintang point for 30 minutes.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Yintang point acupuncture
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory Score
Description
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.
Time Frame
30 minutes after intervention
Secondary Outcome Measure Information:
Title
Amsterdam Preoperative Anxiety and Information Scale Scores
Description
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).
Time Frame
30 minutes after intervention
Title
Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)
Time Frame
Within 30 minutes of surgery
Title
Incidence of Postoperative Nausea and Vomiting (PONV)
Time Frame
24 h postop
Title
Pain Score in the Postanaesthetic Care Unit (PACU)
Description
The number of patients experiencing moderate/severe pain in PACU.
Time Frame
Immediately postop
Title
Pain Score
Time Frame
24 h postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew D Wiles, BM BS FRCA
Organizational Affiliation
Consutant, Sheffield Teachinh Hospital NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail
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