| Methods |
Design: factorial design, 3 (biofeedback, placebo, no biofeedback) x 2 (instructions to increase or decrease heart rate) + 1 (no treatment)
Purpose: examine the effect of biofeedback on anxiety and heart rate |
| Participants |
Patients: psychiatric in‐patients deemed to have a high degree of anxiety problems by their physician
Baseline comparability: yes (anxiety scores, heart rate) |
| Interventions |
Placebo: biofeedback sessions with false positive feedback
Untreated: no sessions (observational)
Experimental: biofeedback sessions with correct feedback
(Co‐intervention: anxiolytics, fixed dosage.) |
| Outcomes |
Anxiety
Heart rate |
| Notes |
Relevant outcome data not accessible |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Relevant outcome data not accessible |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 16 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
