Methods |
Design: four group parallel trial
Purpose: examine the effect of stress management interventions on preoperative anxiety |
Participants |
Patients: older male in‐patients undergoing major surgery
Baseline comparability: yes (anxiety scores) |
Interventions |
Placebo: session of present focus interview prompting discussions on positive activities in the patient's present life
Untreated: no session
Experimental:
‐session of general reminiscence interview prompting patient to recall positive events from the first half of their life
‐session of challenge reminiscence interview prompting the patient to recall successfully met challenges
(Co‐intervention: NS) |
Outcomes |
Anxiety (Spielberger State‐trait Anxiety Inventory)
Coping self‐efficacy inventory
Physiological and postoperative adjustment measures |
Notes |
Relevant outcome data not accessible in trial report but retrieved by contact with authors. |
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/stress management interventions) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15 % or NS |
Free of selective reporting? |
High risk |
Relevant outcome data not accessible in trial report but retrieved by contact with authors. |
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 = 49 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15 % or NS |