Sleep-related impairment among primary-school-aged children Mental and Behavioural Disorders
Conditions
Interventions
Children can enrol in the trial and will be randomised to either the intervention group (sleeping with a comfort item) or the control group (sleeping without a comfort item) and do their trial at home
Sponsors
Trials Methodology Research Network
Ollscoil na Gaillimhe – University of Galway
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any child between 7 and 12 years of age 2. Any child who can understand enough English to understand the website and its contents 3. Any child who has access to the website 4. All children must have guardian consent
Exclusion criteria
Exclusion criteria: 1. A child who does not have guardian consent 2. A child who is unable to understand and give assent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep-related impairment measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v1.0 – Sleep-Related Impairment- Short Form 4a at baseline (Pre-randomisation) and 1 day after trial completion (8 days post-randomisation). Sleep-related impairment is taken using a visual analogue scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall sleep quality is measured using the single-item Sleep Quality Scale (SQS) at baseline (pre-randomisation) and 1 day after trial completion (8 days post-randomisation). Sleep quality is measured using a visual analogue scale (VAS) | — |
Countries
Afghanistan, Åland Islands, Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bonaire Saint Eustatius and Saba, Bosnia and Herzegovina, Botswana, Bouvet Island, Brazil, British Indian Ocean Territory, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Canada, Cayman Islands, Central African Republic, Chad, Chile, China, Christmas Island, Cocos (Keeling) Islands, Colombia, Comoros, Congo, Congo, Democratic Republic, Cook Islands, Costa Rica, Côte d'Ivoire, Croatia, Cuba, Curaçao, Cyprus, Czech Republic, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, England, Equatorial Guinea, Eritrea, Estonia, Eswatini, Ethiopia, Falkland Islands, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Grenada, Guadeloupe, Guam, Guatemala, Guernsey, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and McDonald Islands, Holy See (Vatican City State), Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kiribati, Korea, North, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macao, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Mexico, Micronesia, Federated States of, Moldova, Monaco, Mongolia, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Niue, Norfolk Island, Northern Ireland, Northern Mariana Islands, North Macedonia, Norway, Oman, Pakistan, Palau, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn, Poland, Portugal, Puerto Rico, Qatar, Réunion, Romania, Russian Federation, Rwanda, Saint Barthélemy, Saint Helena, Ascension and Tristan da Cunha, Saint Kitts and Nevis, Saint Lucia, Saint Martin (French part), Saint Pierre and Miquelon, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Scotland, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Sint Maarten (Dutch part), Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Georgia and the South Sandwich Islands, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Svalbard and Jan Mayen, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Türkiye, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States Minor Outlying Islands, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela, Viet Nam, Virgin Islands, British, Virgin Islands, U.S., Wales, Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe
Contacts
Public ContactSimone Lepage
Outcome results
None listed