- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05394389
The Complementary Contributions of Sensory Stimulation and Social Support During Snoezelen Room Therapy on the General Physical and Emotional Health of the Elderly Population: Optimization of the Nursing Home Resources.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pavel Goldstein, PhD
- Phone Number: 0542488445
- Email: pavelg@stat.haifa.ac.il
Study Contact Backup
- Name: Sewar R Khatib, MHA
- Email: sewar94@outlook.com
Study Locations
-
-
North
-
Haifa, North, Israel, 2020000
- Recruiting
- Ahuzat Moriah Shfraam
-
Contact:
- sewar r khatib, MHA student
- Phone Number: AM 0509967091
- Email: sewar94@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: sensory-stimulating therapy
|
therapy session in the snoozlen room accompanied by social support.
Other Names:
|
|
ACTIVE_COMPARATOR: social interaction
|
ten minutes of conversing.
|
|
EXPERIMENTAL: combined sensory-stimulating therapy and social interaction.
|
therapy session in the snoozlen room accompanied by social support.
Other Names:
ten minutes of conversing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain, patient- reported outcome, measured by a ruler from zero to 10, on the Likert scale
Time Frame: four weeks
|
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
|
|
grip strength
Time Frame: eighteen minutes
|
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
|
|
life satisfaction, patient-reported outcome.
Time Frame: four weeks
|
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
|
|
general anxiety disorder, patient- reported outcome
Time Frame: four weeks
|
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
|
|
blood pressure
Time Frame: eighteen minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pulse(heart rate index)
Time Frame: eighteen minutes
|
Continuous quantitative variable, will be measured by "Welch Allyn" measuring instrument\ device.
|
eighteen minutes
|
|
oxygen saturation
Time Frame: eighteen minutes
|
Continuous quantitative variable, will be measured by "Welch Allyn" measuring instrument\ device.
and presents the degree of oxygen concentration in the blood.
|
eighteen minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Upshaifa
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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