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

• ClinicalTrials.gov Identifier: NCT02561572
• Recruitment Status: Completed
• First Posted: September 28, 2015
• Results First Posted: January 31, 2017
• Last Update Posted: March 13, 2017
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: University of Sheffield
• Information provided by (Responsible Party): Sheffield Teaching Hospitals NHS Foundation Trust

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).

Condition or disease	Intervention/treatment	Phase
Anxiety	Other: Acupuncture	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail
• Study Start Date: October 2015
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. State-Trait Anxiety Inventory Score [ Time Frame: 30 minutes after intervention ]
   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 :

1. Amsterdam Preoperative Anxiety and Information Scale Scores [ Time Frame: 30 minutes after intervention ]
   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).
2. Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU) [ Time Frame: Within 30 minutes of surgery ]
3. Incidence of Postoperative Nausea and Vomiting (PONV) [ Time Frame: 24 h postop ]
4. Pain Score in the Postanaesthetic Care Unit (PACU) [ Time Frame: Immediately postop ]
   The number of patients experiencing moderate/severe pain in PACU.
5. Pain Score [ Time Frame: 24 h postop ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United Kingdom

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom, S10 2JF

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

University of Sheffield

Investigators

• Study Chair: Matthew D Wiles, BM BS FRCA; Consutant, Sheffield Teachinh Hospital NHS Foundation Trust

More Information

• Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02561572
• Other Study ID Numbers: STH19048
• First Posted: September 28, 2015
• Results First Posted: January 31, 2017
• Last Update Posted: March 13, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders