Effectiveness of sleeping device to keeping children in position while riding motor vehicles
| ISRCTN | ISRCTN49103785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49103785 |
| Protocol serial number | N/A |
| Sponsor | University of Navarra (Spain) |
| Funder | Developer of Siesta System |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised controlled unblinded crossover intervention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
