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| Name | Class |
|---|---|
| University of Sheffield | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Acupuncture at the Yintang point for 30 minutes. |
|
| Control | No Intervention | No intervention for 30 minutes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Yintang point acupuncture |
|
| 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 |
| 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). |
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Inclusion Criteria:
- Undergoing neurosurgical procedure under general anaesthesia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew D Wiles, BM BS FRCA | Consutant, Sheffield Teachinh Hospital NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospital NHS Foundation Trust | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture |
| FG001 | Control | No intervention for 30 minutes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture |
| BG001 | Control | No intervention for 30 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 30 minutes after intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Matthew Wiles | Sheffield Teaching Hospitals NHS Foundation Trust | 00441142712381 | matthew.wiles@sth.nhs.uk |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG001 |
| Control |
No intervention for 30 minutes. |
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 30 minutes after intervention |
|
|
|
| Secondary | Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU) | Posted | Count of Participants | Participants | Within 30 minutes of surgery |
|
|
|
| Secondary | Incidence of Postoperative Nausea and Vomiting (PONV) | Unable to collect data on wards after discharge from PACU | Posted | 24 h postop |
|
|
| Secondary | Pain Score in the Postanaesthetic Care Unit (PACU) | The number of patients experiencing moderate/severe pain in PACU. | Posted | Count of Participants | Participants | Immediately postop |
|
|
|
| Secondary | Pain Score | Unable to collect data on wards after PACU discharge. | Posted | 24 h postop |
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Control | No intervention for 30 minutes. | 0 | 62 | 0 | 62 | 0 | 62 |
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