Does sleeping with a comfort item make a difference in how well kids sleep compared to not sleeping with a comfort item?

ISRCTN	ISRCTN13756306
DOI	https://doi.org/10.1186/ISRCTN13756306

Submission date: 11/12/2024
Registration date: 10/01/2025
Last edited: 18/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Randomised controlled trials are an important way to answer research questions and are the gold standard to decide if an intervention (like a new medicine or behaviour change) does what it is supposed to do. We think the public, especially kids, should understand what randomised trials are and why they matter. Having a better understanding of randomised trials and health research will also help children think critically about health information they encounter in their daily lives. We thought the best way to teach kids about trials would be to help them conduct one, as they have great ideas and can be great researchers!
The Kid’s Trial is an online, randomised trial that invites kids between 7 and 12 years of age to co-create a trial with us and participate in the trial they create. Participating in The Kid’s Trial will help children understand what randomised trials are and why they matter and help them think critically about health information they encounter in daily life.
In The Kid’s Trial, children around the world were invited to send in low-risk, fun health questions they wanted to test. Children then voted for their favourite question and planned how to answer it. Their chosen question is, ‘Does sleeping with a comfort item (for example, a soft toy or special blanket) make a difference in how well kids sleep compared to not sleeping with a comfort item?’ We are now inviting kids worldwide to join this citizen-science randomised trial called the REST (Randomised Evaluation of Sleeping with a Toy or comfort item) trial.

Who can participate?
Any child around the world between 7 and 12 years of age who can access the study website and understand English

What does the study involve?
When kids (with their guardian’s consent) agree to join the REST trial, they will randomly be put into one of two groups. The intervention, or ‘try-it-out’, group will sleep with a comfort item of their choice for 7 nights in a row. The control, or ‘wait-and-see’, group will not sleep with a comfort item for 7 nights in a row. A computer will decide who goes into which group randomly to make sure that everyone who joins the trial has a fair and equal chance to be in either group. After the trial, kids will fill out a survey where we will ask them about their sleep and how they felt during the trial. The trial results will help the researchers understand if sleeping with a comfort item made a difference in how well kids slept.

What are the possible benefits and risks of participating?
Joining the REST trial could benefit kids by helping them learn about health research and randomised trials and improve their critical-thinking skills. The results will also help the researchers understand kids’ sleep better.
Joining the REST trial shouldn’t be risky for children or their parents or caregivers. There is a possibility that some children would like to be in a different group than the one that they are randomised to. Children can withdraw from the trial at any point, and no one will be upset by this.

Where is the study run from?
This study is based in the School of Nursing and Midwifery in the College of Medicine, Nursing, and Health Sciences, University of Galway, Galway, Ireland.

When is the study starting, and how long is it expected to run?
November 2021 to June 2025

Who is funding this study?
1. Health Research Board – Trials Methodology Research Network of Ireland
2. University of Galway (Ireland)

Who is the main contact?
Simone Lepage, s.lepage1@universityofgalway.ie

Study website

Contact information

Ms Simone Lepage
Public, Scientific, Principal Investigator

Aras Moyola
School of Nursing and Midwifery, Upper Newcastle Road
Galway
H91 HX31
Ireland

ORCID ID	0000-0001-6473-057X
Phone	+353 (0)91 493 432
Email	s.lepage1@universityofgalway.ie

Study information

Study design	Online pragmatic superiority unblinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	The participant information sheets can be found on the homepage https://www.thekidstrial.ie/ under the ‘Parents’ & Caregivers’ Information Flipbook’ and the ‘Kids’ Information Flipbook’.
Scientific title	The Kid’s REST (Randomised Evaluation of Sleeping with a Toy or comfort item) Trial: an online, randomised trial of comfort item use on sleep quality in children
Study acronym	The Kid’s REST Trial
Study objectives	Does sleeping with a comfort item (for example, a soft toy or special blanket) make a difference to how well kids (between the ages of 7 and 12 years of age) sleep compared to not sleeping with a comfort item?
Ethics approval(s)	Approved 16/02/2023, University of Galway Research Ethics Committee (The Research Office, University of Galway, Galway, H91 TK33, Ireland; +353 (0)91 495312; ethics@universityofgalway.ie), ref: 2023.02.014
Health condition(s) or problem(s) studied	Sleep-related impairment among primary-school-aged children
Intervention	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 for 7 days. Both groups (intervention and control) will do the trial at home for 7 consecutive days. Participants will be randomised to their allocated group upon joining the trial in a 1:1 ratio. Due to the nature of the trial, blinding is not possible for either participants or researchers. The intervention group (also called the ‘try-it-out’ group) will: 1. Choose one comfort item (the comfort item can be any item of choice that a child identifies, for example, a toy, blanket, or other item safe to sleep with) to sleep with for the duration of the trial before starting the trial 2. Sleep with the same comfort item each night for the duration of the trial 3. Start using their comfort when they start getting ready for bed (for example, if they normally read a book before bed, they should use their comfort item then and take it with them when they go to bed) each night for the duration of the trial 4. Sleep in their usual bed each night for the duration of the trial (if a child has more than one home, for example, a boarding school or multiple family homes, both will be considered their usual bed) 5. Keep everything else about their bedtime the same as usual The control group (also called the ‘wait-and-see’ group) will: 1. Not sleep with any comfort items at night for the duration of the trial 2. Sleep in their usual bed each night for the duration of the trial (if a child has more than one home, for example, a boarding school or multiple family homes, both will be considered their usual bed) 3. Keep everything else about their bedtime the same as usual
Intervention type	Behavioural
Primary outcome measure	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 outcome measures	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)
Overall study start date	01/11/2021
Completion date	01/06/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	7 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	292
Key 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
Key exclusion criteria	1. A child who does not have guardian consent 2. A child who is unable to understand and give assent
Date of first enrolment	13/01/2025
Date of final enrolment	01/06/2025

Locations

Countries of recruitment

Afghanistan
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
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
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
North Macedonia
Northern Ireland
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
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
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
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
Åland Islands

Study participating centre

University of Galway

College of Medicine, Nursing, and Health Sciences
School of Nursing & Midwifery
Aras Moyola
Upper Newcastle Road
Galway
H91 HX31
Ireland

Sponsor information

Trials Methodology Research Network
Research organisation

Aras Moyola
School of Nursing and Midwifery
Upper Newcastle Road
Galway
H91 HX31
Ireland

Phone	+353 (0)91 494492
Email	hrb-tmrn@universityofgalway.ie
Website	https://www.hrb-tmrn.ie/
"ROR"	https://ror.org/05y8p4437

Ollscoil na Gaillimhe – University of Galway
University/education

College of Medicine, Nursing, and Health Sciences
University Road
Galway
H91 TK33
Ireland

Phone	+353 (0)91 524411
Email	cmnhs@universityofgalway.ie
Website	https://www.universityofgalway.ie/medicine-nursing-and-health-sciences/
"ROR"	https://ror.org/03bea9k73

Funders

Funder type

Government

Health Research Board
Government organisation / Local government

Alternative name(s): Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
Location: Ireland

University of Galway
Government organisation / Universities (academic only)

Alternative name(s): Coláiste na hOllscoile, Gaillimh, Ollscoil na hÉireann Gaillimh, Queen's College, Galway, University College, Galway, NUI Galway, National University of Ireland, Galway, National University of Ireland Galway, Ollscoil na Gaillimhe, National University of Ireland, Galway/NUI Galway, NUI Galway, OÉ Gaillimh
Location: Ireland

Results and Publications

Intention to publish date	01/06/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
Publication and dissemination plan	The researchers expect two publications to result from this research study. They plan to describe the processes used in the creation of the citizen science project, The Kid’s Trial, in a peer-reviewed trials methodology journal. The second publication will describe the REST trial methods and results in a peer-reviewed journal. The results of the trial will be presented at international conferences for trial methodology and clinical trials. The researchers will also publish the results of the REST trial on their website and in a yet unknown method based on the final step of The Kid’s Trial, where they will ask children how they would like to share their results.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. The repository used is Open Science Framework (OSF): https://osf.io/tsre8/. The results shared will be those collected from participating kids in the REST trial and will be made available once the trial is complete and after full anonymisation of the data is complete. These records will remain in the OSF database. Parents of participants are aware that data will be published only after it is completely anonymised.

Editorial Notes

18/03/2025: Internal review.
11/12/2024: Study's existence confirmed by the University of Galway Research Ethics Committee.