Effectiveness of sleeping device to keeping children in position while riding motor vehicles
| ISRCTN | ISRCTN49103785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49103785 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/02/2011
- Registration date
- 07/04/2011
- Last edited
- 08/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maria Segui-Gomez
Scientific
Scientific
European Center for Injury Prevention
School of Medicine
University of Navarra
Ed. Castaños S200
Irunlarrea 1
Pamplona
31190
Spain
Study information
| Study design | Single centre randomised controlled unblinded crossover intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effectiveness of sleeping device to keeping children in position while riding motor vehicles: a non-blinded single centre controlled crossover interventional randomised trial |
| Study objectives | A new (copyrighted) sleeping device will allow children to maintain head, neck and torso in position while asleep during travel, therefore reducing the chances of out of position (OOP) risky behaviors |
| Ethics approval(s) | University of Navarra Ethics Committee pending as of 22/02/2011 |
| Health condition(s) or problem(s) studied | Sleeping position |
| Intervention | Comparator: Regular sleeping aids (if any): pillows, blankets, folded clothing, stuffed animal, etc., anything the child regularly uses when travelling to make him/herself more comfortable. Intervention: Siesta System sleeping device, a head suspender device that mimicks the concept of a hammock. The device is copyrighted and patented. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Percent of the travel time in which the child in out of position as observed by markers placed and recorded with a triaxial camera system that records all the travel. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/09/2010 |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Children ages 7-12 (inclusive) 2. Either sex 3. Maximum height 150 cm |
| Key exclusion criteria | 1. Acute disease at time of experiment 2. Children with travel sickness 3. Morbidly obese children 4. Children with behavioural issues that would make it difficult collaborating in the experiment 5. Does not match inclusion criteria |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
European Center for Injury Prevention
Pamplona
31190
Spain
31190
Spain
Sponsor information
University of Navarra (Spain)
University/education
University/education
c/o Javier Ferro
European Center for Injury Prevention
School of Medicine
University of Navarra
Irunlarrea 1
Pamplona
31190
Spain
"ROR" |
https://ror.org/02rxc7m23 |
|---|
Funders
Funder type
Industry
Developer of Siesta System
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
