- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01100541
Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy
The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort, appearance, weight, superficial temperature, and other characteristics of a polymeric plate derived from castor oil developed to thermotherapy.
The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and then fill in, without interference of the researcher, some questions about the characteristics of interest.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
In this study, the polymeric plate is prepared using the following procedure:
- - the water is heated to the boiling temperature
- - the heater is shut down
- - the polymeric plate is immersed in water
- - it rests in the water for 15 minutes
- - it is inserted in a wrap
In this condition, the polymeric plate is placed on the shoulder of the volunteer and remains there for 20 minutes.
After application, the volunteer answers the questionnaire containing eight questions on a Likert scale (0 to 10) and an area of observations.
Previous laboratory tests were performed to ensure that the temperature of the polymeric plate will not cause skin burn in this application condition.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
SP
-
Sao Carlos, SP, Brasil, 13566-590
- Interunits postgraduate program in bioengineering
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Good communication and comprehension
- Skin integrity
Exclusion Criteria:
- Reduced skin sensitivity
- Disturbance in the central nervous system
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Polymeric plate characteristics
Evaluation, in the volunteers viewpoint, of the polymeric plate characteristics.
|
Application of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptance of the polymeric plate
Tidsramme: 2 weeks
|
Acceptance of the polymeric plate by the volunteers.
|
2 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Polymeric plate comfort
Tidsramme: 2 weeks
|
Perception of the volunteers about the comfort of the polimeric plate.
|
2 weeks
|
|
Polymeric plate temperature
Tidsramme: 2 weeks
|
Perception of the volunteers about the polymeric plate temperature.
|
2 weeks
|
|
Polymeric plate time of heat retention
Tidsramme: 2 weeks
|
Perception of the volunteers about the polymeric plate time of heat retention.
|
2 weeks
|
|
Sensation on the superficial touch of the polymeric plate
Tidsramme: 2 weeks
|
Perception of the volunteers about the sensation on the superficial touch of the polymeric plate.
|
2 weeks
|
|
Appearance of the polymeric plate
Tidsramme: 2 weeks
|
Perception of the volunteers about the appearence of the polymeric plate.
|
2 weeks
|
|
Polymeric plate weight
Tidsramme: 2 weeks
|
Perception of the volunteers about the polymeric plate weight.
|
2 weeks
|
|
Polymeric plate practicality
Tidsramme: 2 weeks
|
Perception of the volunteers about the polymeric plate practicality.
|
2 weeks
|
|
General observations about the polymeric plate
Tidsramme: 2 weeks
|
General comments, suggestions and complaints of the volunteers about the polymeric plate.
|
2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Fabiula BM dos Santos, Physio, University of Sao Paulo
- Studieleder: Valéria MC Elui, PhD, University of Sao Paulo
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CEPHCFMRPUSP-11099
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