LonelinessNCT05394389
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.
A study testing sensory stimulating therapy and social support in people with Loneliness and Aging, run by Pavel Goldstein at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Aging
- What is being tested?
- sensory stimulating therapy and social support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients living in the Ahuzat Moriah nursing home\ geriatric nursing hospital in Shefar'am.
Who cannot join
- Patients with epilepsy and aggressive patients. *We do not limit the participation of patients whose cognitive level is very low.
Trial locations and contacts
1 site in 1 country.
Sewar R Khatib, MHA contact
Israel1 site, 1 recruiting
- Recruiting
Ahuzat Moriah Shfraam
Haifa, North, 2020000
sewar r khatib, MHA student, 0509967091 ext. AM, sewar94@gmail.com
About this study
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.
Read more
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.
- Conditions
- Loneliness, Aging
- Being tested
- sensory stimulating therapy, social support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory stimulating therapyOther
Also called integrative approach sensory stimulating therapy and social support
therapy session in the snoozlen room accompanied by social support.
social supportOther
ten minutes of conversing.
| Study group | Role | What they receive |
|---|---|---|
| sensory-stimulating therapy | Active comparator | Not described Receives: Other: sensory stimulating therapy |
| social interaction | Active comparator | Not described Receives: Other: social support |
| combined sensory-stimulating therapy and social interaction. | Experimental | Not described Receives: Other: sensory stimulating therapy; Other: social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four weeks
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.
Measured: eighteen minutes
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.
Measured: four weeks
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.
Measured: four weeks
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.
Measured: eighteen minutes
Secondary outcomes (2)
pulse(heart rate index)
Continuous quantitative variable, will be measured by "Welch Allyn" measuring instrument\ device.
Measured: eighteen minutes
oxygen saturation
Continuous quantitative variable, will be measured by "Welch Allyn" measuring instrument\ device. and presents the degree of oxygen concentration in the blood.
Measured: eighteen minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jan 2022
- Primary completion15 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pavel Goldstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pavel Goldstein, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394389
- Sponsor's protocol ID
- Upshaifa
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khatib S, Palgi Y, Ashar YK, Polyvyannaya N, Goldstein P. The Combined Effect of Multisensory Stimulation and Therapist Support on Physical and Mental Health of Older Adults Living in Nursing Homes: Pilot Randomized Controlled Trial. J Med Internet Res. 2025 Jan 14;27:e55042. doi: 10.2196/55042.
PubMed 39808474
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05394389
- Acronym / sponsor ID
- Upshaifa
- Conditions
- Loneliness, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pavel GoldsteinUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sensory-stimulating therapy | Active comparator | Other: sensory stimulating therapy |
| social interaction | Active comparator | Other: social support |
| combined sensory-stimulating therapy and social interaction. | Experimental | Other: sensory stimulating therapy, Other: social support |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients living in the Ahuzat Moriah nursing home\ geriatric nursing hospital in Shefar'am.
Key exclusion criteria (1 listed)
- Patients with epilepsy and aggressive patients. *We do not limit the participation of patients whose cognitive level is very low.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensory stimulating therapyAlso: integrative approach sensory stimulating therapy and social supporttherapy session in the snoozlen room accompanied by social support. | Other | combined sensory-stimulating therapy and social interaction., sensory-stimulating therapy |
| social supportten minutes of conversing. | Other | combined sensory-stimulating therapy and social interaction., social interaction |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
pulse(heart rate index)
Time frame: eighteen minutes
oxygen saturation
Time frame: eighteen minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 39808474Khatib S, Palgi Y, Ashar YK, Polyvyannaya N, Goldstein P. The Combined Effect of Multisensory Stimulation and Therapist Support on Physical and Mental Health of Older Adults Living in Nursing Homes: Pilot Randomized Controlled Trial. J Med Internet Res. 2025 Jan 14;27:e55042. doi: 10.2196/55042.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sewar R Khatib, MHA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory stimulating therapy and social support in people with Loneliness and Aging, run by Pavel Goldstein at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel Goldstein, PhD (0542488445, pavelg@stat.haifa.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain, patient- reported outcome, measured by a ruler from zero to 10, on the Likert scale (time frame: four weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.