Trial Outcomes & Findings for The Effect of Acupuncture on Pre-operative Anxiety Levels in Neurosurgical Patients: a Randomised, Controlled Trail (NCT NCT02561572)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

30 minutes after intervention

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture	Control No intervention for 30 minutes.
Overall Study STARTED	64	64
Overall Study COMPLETED	62	62
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture	Control No intervention for 30 minutes.
Overall Study Inadequate time before surgery	2	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=62 Participants Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture	Control n=62 Participants No intervention for 30 minutes.	Total n=124 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 13.6 • n=5 Participants	54 years STANDARD_DEVIATION 17.5 • n=7 Participants	54.7 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex/Gender, Customized Female	36 participants n=5 Participants	32 participants n=7 Participants	68 participants n=5 Participants
Sex/Gender, Customized Male	26 participants n=5 Participants	30 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture	Control n=62 Participants No intervention for 30 minutes.
State-Trait Anxiety Inventory Score	40.0 units on a scale Interval 30.0 to 46.7	43.3 units on a scale Interval 36.7 to 50.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture	Control n=62 Participants No intervention for 30 minutes.
Amsterdam Preoperative Anxiety and Information Scale Scores	7 units on a scale Interval 4.0 to 10.0	8.5 units on a scale Interval 6.0 to 12.0

SECONDARY outcome

Timeframe: Within 30 minutes of surgery

Outcome measures

Outcome measures
Measure	Intervention n=57 Participants Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture	Control n=49 Participants No intervention for 30 minutes.
Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 h postop

Population: Unable to collect data on wards after discharge from PACU

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediately postop

The number of patients experiencing moderate/severe pain in PACU.

Outcome measures

Outcome measures
Measure	Intervention n=57 Participants Acupuncture at the Yintang point for 30 minutes. Acupuncture: Yintang point acupuncture	Control n=49 Participants No intervention for 30 minutes.
Pain Score in the Postanaesthetic Care Unit (PACU)	28 Participants	21 Participants

SECONDARY outcome

Timeframe: 24 h postop

Population: Unable to collect data on wards after PACU discharge.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Matthew Wiles

Sheffield Teaching Hospitals NHS Foundation Trust

Phone: 00441142712381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place