NCT05394389

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

May 26, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • pulse(heart rate index)

    eighteen minutes

  • oxygen saturation

    eighteen minutes

Study Arms (3)

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 therapyOther: social support

Interventions

therapy session in the snoozlen room accompanied by social support.

Also known as: integrative approach sensory stimulating therapy and social support
combined sensory-stimulating therapy and social interaction.sensory-stimulating therapy

ten minutes of conversing.

combined sensory-stimulating therapy and social interaction.social interaction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients living in the Ahuzat Moriah nursing home\\ geriatric nursing hospital in Shefar'am.

You may not qualify if:

  • Patients with epilepsy and aggressive patients. \*We do not limit the participation of patients whose cognitive level is very low.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahuzat Moriah Shfraam

Haifa, North, 2020000, Israel

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

Pavel Goldstein, PhD

CONTACT

Sewar R Khatib, MHA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Integrative Pain Laboratory

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 27, 2022

Study Start

January 1, 2022

Primary Completion

July 15, 2022

Study Completion

December 30, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations