| Methods |
Single‐blind, randomised controlled trial of audio‐analgesia. The allocation sequence and concealment of the allocation sequence was unclear. It was unclear whether the outcome assessor and analyst were blind. |
| Participants |
25 women with a singleton pregnancy in the first stage of labour were randomised to the trial. The trial was undertaken in England. Women were excluded if they had a history of ear disease or vestibular disturbance. |
| Interventions |
Women in the experimental arm listened to white sound set at 120 decibels. Control cases listened to white sound at a maximum 90 decibels (it was presumed at this level there is no physiological effect). The intervention started when the woman was in established labour. If the women became tired the audio‐analgesia was stopped and resumed later. If the midwife considered the pain relief inadequate, the audio analgesia was stopped and inhalation analgesia started. |
| Outcomes |
Midwife's opinion of pain relief from audio‐analgesia, woman's satisfaction with 'sea noise'. |
| Notes |
One (4%) woman withdrew from the trial. There was no sample‐size calculation. No details were provided on baseline characteristics. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
