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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05394389
Other study ID # Upshaifa
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 30, 2022

Study information

Verified date May 2022
Source University of Haifa
Contact Pavel Goldstein, PhD
Phone 0542488445
Email pavelg@stat.haifa.ac.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Over time, lifespan is extending, the population is aging, and accordingly there is a great demand for hospital beds in nursing homes, increasing attention to this population and the services they receive. Mostly, elderly population living in nursing homes suffers from dementia, Alzheimer, depression, agitation, and other diseases that require multidisciplinary treatment. In addition to the medical and pharmacological treatments that patients receive to maintain functional medical status, there is a great need for non-pharmacological treatments, that may improve quality of life, mental well-being, and life satisfaction. There are several treatment approaches of multisensory stimulation environment (MSSE). MSSE in the Snoezelen room therapy recognized as benefiting the patients' physical, mental, and emotional health status. In addition, there is great importance of intervention by social interaction, support, and encouragement. However, the effect of combined intervention of MSSE in Snoezelen room therapy and social support, has not yet been sufficiently studied in elderly patients in nursing homes. These two interventions - together - are supposed to have an increased effect on physical and mental wellbeing of elderly.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients living in the Ahuzat Moriah nursing home\ geriatric nursing hospital in Shefar'am. Exclusion Criteria: - Patients with epilepsy and aggressive patients. *We do not limit the participation of patients whose cognitive level is very low.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
sensory stimulating therapy
therapy session in the snoozlen room accompanied by social support.
social support
ten minutes of conversing.

Locations

Country Name City State
Israel Ahuzat Moriah Shfraam Haifa North

Sponsors (1)

Lead Sponsor Collaborator
Pavel Goldstein

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain, patient- reported outcome, measured by a ruler from zero to 10, on the Likert scale An interval variable measured by a ruler from zero to 10, on the Likert scale, and with the help of illustrations of faces, the farther away from zero, the higher the intensity of pain. four weeks
Primary grip strength A continuous quantitative variable presented in numerical values of isometric grip force from 0 to 90 kg and will be measured by Jamar hydraulic dynamometer. The hand grip strength will be measured in a hydraulic dynamometer borrowed from the university. The assessment does not involve any potential damage, a two-minute test in which the subject is required to press a device to measure grip strength. eighteen minutes
Primary life satisfaction, patient-reported outcome. using the SWLS questionnaire before the first session and after the fourth(last) session as an estimation tool .Interval variable, showing scores ranging from 5-35, on the Likert scale, the higher the score it indicates more life satisfaction. four weeks
Primary general anxiety disorder, patient- reported outcome using the GAD questionnaire before the first session and after the fourth(last) session as an estimation tool.GAD- is an interval variable, which will be measured using the sum of the reports on the 7 statements on the Likert scale from 0 to 3, the higher the score on this questionnaire, the higher the level of anxiety among the patient. The total score range is from 0-21. four weeks
Primary blood pressure Continuous quantitative variable, will be measured by a blood pressure monitor "Welch Allyn" measuring instrument\ device and quantitatively represented, this result variable will examine the quantitative change in systolic and diastolic blood pressure. eighteen minutes
Secondary pulse(heart rate index) Continuous quantitative variable, will be measured by "Welch Allyn" measuring instrument\ device. eighteen minutes
Secondary oxygen saturation Continuous quantitative variable, will be measured by "Welch Allyn" measuring instrument\ device. and presents the degree of oxygen concentration in the blood. eighteen minutes
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