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

NCT02561572 | Completed Results

• 1 other identifier: STH19048
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Amsterdam Preoperative Anxiety and Information Scale Scores

  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)

  Immediately postop

• Pain Score

  24 h postop

Study Arms (2)

Intervention

EXPERIMENTAL

Acupuncture at the Yintang point for 30 minutes.

Other: Acupuncture

Control

NO INTERVENTION

No intervention for 30 minutes.

Interventions

Acupuncture OTHER

Yintang point acupuncture

Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Undergoing neurosurgical procedure under general anaesthesia

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Dr Matthew Wiles
• Organization: Sheffield Teaching Hospitals NHS Foundation Trust

matthew.wiles@sth.nhs.uk

00441142712381

Study Officials

• Matthew D Wiles, BM BS FRCA

  Consutant, Sheffield Teachinh Hospital NHS Foundation Trust

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 28, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 13, 2017
• Results First Posted: January 31, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)