| Methods |
Design: four group parallel trial
Purpose: examine the effect of two different relaxation techniques on insomnia |
| Participants |
Patients: media recruited out‐patients suffering from insomnia
Baseline comparability: yes (time to fall asleep) |
| Interventions |
Placebo: sessions of self relaxation without any technique being taught
Untreated: no sessions
Experimental: sessions of taught techniques of relaxation:
‐autogenic training (focusing on heaviness and warmth of legs and arms)
‐progressive relaxation (muscle tension‐release cycles)
(Co‐intervention: no) |
| Outcomes |
Sleep latency (minutes)
Hours slept
Number of awakenings
Overall quality of the night's sleep (fatigue, depression, ability to relax, feeling of anxiety, ability to function at work and irritability during day)
Pupillography |
| 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 techniques) |
| 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? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
High risk |
N = 16 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
