| Methods |
Design: three group parallel trial
Purpose: examine the effect of a relaxation tape session on preoperative anxiety |
| Participants |
Patients: in‐patients undergoing day‐case surgery
Baseline comparability: yes, except for diastolic blood pressure |
| Interventions |
Placebo: session where patients listen to a recorded short story
Untreated: no session
Experimental: session where patients listen to a recorded relaxation procedure
(Co‐intervention: NS) |
| Outcomes |
Anxiety (Spielberger state trait anxiety inventory)
Heart rate
Blood pressure
Anaesthesia measures (dose of sedative, time to settle the patient, mean concentration per min of isoflurane, anaesthetist's score) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/relaxation procedure) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
High risk |
N = 14 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
