| Methods |
Design: four group parallel trial
Purpose: examine the effect of cognitive‐behavioural and patient education interventions on the anxiety related to cardiac catheterization |
| Participants |
Patients: in‐patients undergoing cardiac catheterization
Baseline comparability: yes |
| Interventions |
Placebo: pre‐catheterization session where patients' feelings were discussed, avoiding coping skills, procedures or factual information
Untreated: no sessions (observational group)
Experimental: sessions with:
‐cognitive‐behavioural training in anxiety coping strategies
‐patient education: factual information on heart diseases and the procedure of cardiac catherization
(Co‐intervention: NS) |
| Outcomes |
Anxiety (Spielberger state trait anxiety inventory)
Pain
Anger |
| 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/active) |
| 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? |
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 = 22 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
