Randomization and interventions
AIDS, RECRUITMENT, PCT
Randomization to EMEP (intervention) or HB (sham/placebo) was through the strict sequential opening of lowest numbered available sealed and opaque envelope. Randomization sequences were prepared using a random number sequencer (random.org) in random blocks of 4 or 8 and within block by a co-author (PCT) who was not involved in recruitment.Participants randomized to intervention were provided with eye-mask and earplugs were instructed to wear them when they go to bed at night until delivery. EMEP can be removed if the participant needed to mobilize during the night but to be re-worn on returning to bed to sleep. Participants randomized to HB were instructed to wear it circumferentially at the level of the brow when they go to bed to sleep at night. The sleep aids were to be removed upon wakening [After a two-week interval, co-investigator (AV) made a phone call to the participants and asked four questions through an ad hoc sleep questionnaire to assess the sleep quality. Participants were asked to provide experience data on the two weeks since starting the allocated sleep aid intervention; 1) a 5-grade Likert scale response to “since using the sleep aid for the last one week, I have slept better”, 2) to rate using a 11-point visual numerical rating scale (VNRS rated from 0 to 10, higher score greater satisfaction) their “satisfaction with the use of allocated sleep aid” 3) to estimate average night sleep duration (hours) and 4) to give an estimate number of times use of their allocated sleep aid in a week. Standard maternity care was provided to all participants.Sleep aids were purchased from an online store at a cost of less than USD 1 per set and a new set of allocated sleep aids were provided to each participant as allocated and reused nightly by them during the period of study until no longer fit for purpose. Labor and birth outcomes were retrieved from hospital records after participants’ delivery. All participants’ relevant demographic and clinical data were transcribed onto the Case Report Form.