- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
SP
-
Sao Carlos, SP, Brasilien, 13566-590
- Interunits postgraduate program in bioengineering
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Good communication and comprehension
- Skin integrity
Exclusion Criteria:
- Reduced skin sensitivity
- Disturbance in the central nervous system
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Acceptance of the polymeric plate
Tidsram: 2 weeks
|
Acceptance of the polymeric plate by the volunteers.
|
2 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Polymeric plate comfort
Tidsram: 2 weeks
|
Perception of the volunteers about the comfort of the polimeric plate.
|
2 weeks
|
Polymeric plate temperature
Tidsram: 2 weeks
|
Perception of the volunteers about the polymeric plate temperature.
|
2 weeks
|
Polymeric plate time of heat retention
Tidsram: 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
Tidsram: 2 weeks
|
Perception of the volunteers about the sensation on the superficial touch of the polymeric plate.
|
2 weeks
|
Appearance of the polymeric plate
Tidsram: 2 weeks
|
Perception of the volunteers about the appearence of the polymeric plate.
|
2 weeks
|
Polymeric plate weight
Tidsram: 2 weeks
|
Perception of the volunteers about the polymeric plate weight.
|
2 weeks
|
Polymeric plate practicality
Tidsram: 2 weeks
|
Perception of the volunteers about the polymeric plate practicality.
|
2 weeks
|
General observations about the polymeric plate
Tidsram: 2 weeks
|
General comments, suggestions and complaints of the volunteers about the polymeric plate.
|
2 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Fabiula BM dos Santos, Physio, University of Sao Paulo
- Studierektor: Valéria MC Elui, PhD, University of Sao Paulo
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CEPHCFMRPUSP-11099
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