Phase None Completed NCT02670993

Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME

Centre Hospitalier Universitaire de Saint Etienne · Interventional, Randomized

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Completed June 2016. Read the results summary below →

Study context: no flags matched. Amendment history is not available for this trial's data source.

Overview

Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.

Full record on ClinicalTrials.gov (NCT ID NCT02670993).

Results summary

None

Outcome data

EndpointTypeResultSignificance
Score at the EVS = simplified visual scale Primary None None
Score at the EN (digital scale) scale Secondary None None
Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory Secondary None None

Full results record on ClinicalTrials.gov.

Study design

Phase
Phase None
Study type
Interventional
Allocation
Randomized
Masking
Open label
Intervention model
Parallel assignment
Enrollment (final)
59 participants
Actually completed
June 2016

Recruitment criteria

Age range: ≥ 60 · Sex: All · Healthy volunteers: Requires diagnosis

Locations

2 sites participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

Hospices civils de Lyon — Lyon (France)
Chu Saint Etienne — Saint-Etienne (France)

Sources

REG
ClinicalTrials.gov — NCT02670993
Trial registry · primary record
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