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| Name | Class |
|---|---|
| Health Research Board, Ireland | OTHER |
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The People's trial is an online pragmatic, randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.
The People's Trial seeks to help enhance the public's understanding of randomised trials by facilitating the involvement of the public in the trial research process. The public have, through an online format, guided the development and design of The People's Trial randomised controlled trial. The People's trial is a parallel, online randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.
Members of the public will be recruited through online platforms. Informed consent will be obtained from all participants prior to trial registration. Consent forms will be provided online prior to registration for The People's Trial. Participants will be required to acknowledge that they have read the consent form and give consent to proceed with trail registration.
Participants will be randomly allocated into one of two groups:
Group 1: Reading a book in bed
Group 2: Not reading a book in bed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reading group | Experimental | Participants will:
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| Control Group | No Intervention | Participants will: 1. Not read a book |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reading a book | Other | Participants requested to specify usual genre of book they read.
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| Measure | Description | Time Frame |
|---|---|---|
| Overall sleep quality | Sleep quality will be measured using the single item sleep quality scale (SQS) (Snyder et al 2018). The SQS is a self-administered questionnaire in which respondents rate overall quality of sleep over a 7-day recall period on a discretizing visual analogue scale from 0 to 10 (0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent) | From time of randomisation- refers to sleep in the last 7 days only |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbance | This will be measured using the PROMIS Short Form Sleep Disturbance Scale which measures eight items on 5-point scale to rate the frequency of problems related to insufficient sleep in the past seven days | From time of randomisation- refers to sleep in the last 7 days only |
| Daytime sleepiness |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Declan Devane, Professor | National University of Ireland, Galway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Ireland Galway | Galway | Co. Galway | H91 TK33 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35264220 | Derived | Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. The People's Trial: supporting the public's understanding of randomised trials. Trials. 2022 Mar 9;23(1):205. doi: 10.1186/s13063-021-05984-1. | |
| 34996514 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2022 | |
| Reset | Jun 23, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2022 | Jun 23, 2022 |
| ID | Term |
|---|---|
| C564092 | Bornholm Eye Disease |
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The People's Trial is an online pragmatic, randomised controlled trial.
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Perceptions of daytime sleepiness will be measured using a a single item with a 10-point scale. Respondents are instructed to indicate their sleepiness at that moment by choosing a number between 1 (not sleepy at all) and 10 (very sleepy). Others have found a single item to measure sleep quality produces reproducible and valid data (Cappelleri, et al 2009, Riegel et al 2013). |
| From time of randomisation- refers to sleep in the last 7 days only |
| Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed? The People's Trial-an online, pragmatic, randomised trial. Trials. 2021 Dec 4;22(1):873. doi: 10.1186/s13063-021-05831-3. |