Dementiasn/dmNCT06216275
Enhancing Calm in Arab Elderly With Dementia
A study testing Integrated Snoezelen-Aromatherapy-Personal Item Therapy in people with Dementia and Agitation in Dementia, Including Alzheimer's Disease, run by Mostafa Shaban at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of integrating Snoezelen methods with aromatherapy and personal items in reducing agitation in Arab elderly individuals with dementia. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Dementia, Agitation in Dementia, Including Alzheimer's Disease
- What is being tested?
- Integrated Snoezelen-Aromatherapy-Personal Item Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2024to 1 Mar 2024
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Participants must be 65 years to 90 years
- Diagnosis: Clinical diagnosis of dementia required.
- Ethnicity: Must be of Arab descent.
- Agitation Levels: Must show agitation signs based on a standardized scale.
- Cognitive Function: Adequate cognitive function for study participation, verified by standard assessment.
Who cannot join
- Severe Medical Conditions: Individuals with severe medical conditions that could affect study participation or health.
- Advanced Dementia: Patients with very advanced dementia stages, unable to engage in study activities.
- Allergies: Known allergies to aromatherapy products used in the study.
- Recent Medication Changes: Significant changes in dementia medication regimen before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Calm in Arab Elderly With Dementia: Integrating Snoezelen Methods With Aromatherapy and Personal Items to Reduce Agitation
The goal of this clinical trial is to evaluate the effectiveness of integrating Snoezelen methods with aromatherapy and personal items in reducing agitation in Arab elderly individuals with dementia. The main questions it aims to answer are:
Does the combination of Snoezelen methods, aromatherapy, and the use of personal items significantly reduce agitation in elderly Arab patients with dementia compared to standard care practices? How do patients and caregivers perceive the impact of this integrated approach on the overall well-being and quality of life of the patients?
Read more
Participants in this study will:
Engage in sessions utilizing Snoezelen methods, a multi-sensory environment designed to deliver stimuli to various senses.
Receive aromatherapy treatments with selected scents known for their calming properties.
Be provided with personal items that are familiar and meaningful to them, to create a sense of comfort and security.
Read the detailed description
This clinical trial is centered on a novel approach to dementia care, specifically targeting the Arab elderly demographic. It uniquely combines three elements - Snoezelen therapy, aromatherapy, and the use of personal items - to address agitation, a common and challenging symptom in dementia patients.
Snoezelen Therapy Implementation:
Custom-designed Snoezelen rooms will be used, equipped with lights, colors, sounds, and textures to stimulate senses in a controlled manner.
Sessions will be tailored to individual patient needs and preferences, monitored by trained staff.
Aromatherapy Application:
Selection of aromas will be based on their known calming properties, with a focus on cultural relevance and acceptability in the Arab elderly population.
The method of delivery and duration of each aromatherapy session will be standardized to ensure consistency across the study.
Incorporation of Personal Items:
Patients will be encouraged to select personal items that hold significant emotional value or are tied to pleasant memories.
These items will be integrated into the therapy sessions to provide a sense of familiarity and emotional comfort.
Data Collection and Analysis:
Quantitative data on agitation levels will be gathered using established agitation scales, both pre- and post-intervention.
The study aims to provide a comprehensive evaluation of how this integrated approach can influence agitation in dementia, considering both statistical effectiveness and personal experiences. The outcome will contribute valuable insights into dementia care practices, particularly for the Arab elderly population, and may offer a template for culturally sensitive dementia care.
- Being tested
- Integrated Snoezelen-Aromatherapy-Personal Item Therapy
- Keywords
- Dementia Care, Agitation in Elderly, Arab Elderly Dementia, Snoezelen Therapy, Aromatherapy in Dementia, Multi-sensory Stimulation
- Medical subject headings
- Dementia, Aberrant Motor Behavior in Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Snoezelen-Aromatherapy-Personal Item TherapyBehavioural
Intervention Description:
This unique intervention combines three distinct therapeutic approaches specifically tailored for Arab elderly patients with dementia experiencing agitation.
Snoezelen Therapy: Customized sessions in a Snoezelen environment - a specialized room designed to deliver controlled multi-sensory stimuli. This room features adaptable lighting, colors, sounds, and textures to provide a soothing and stimulating experience. Sessions are personalized based on each patient's response and preference, under the guidance of trained professionals.
Aromatherapy: Carefully selected essential oils known for their calming properties are used in a culturally sensitive manner. These oils are diffused in the environment or used during individual sessions to provide a relaxing olfactory experience. The choice of oils and method of delivery are standardized
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants receiving the integrated approach of Snoezelen therapy, aromatherapy, and the use of personal items. Receives: Behavioral: Integrated Snoezelen-Aromatherapy-Personal Item Therapy |
| Control Arm | No intervention | Participants receiving standard care practices for dementia and agitation without the integrated approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Agitation Levels
The primary outcome measure is the reduction in agitation levels among the Arab elderly with dementia participating in the study. This will be quantitatively assessed using a validated agitation scale, such as the Cohen-Mansfield Agitation Inventory (CMAI) or a similar tool appropriate for dementia patients.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start5 Jan 2024
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mostafa Shaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216275
- Sponsor's protocol ID
- Snoezelen_Demntia
- Acronym
- sn/dm
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith BC, D'Amico M. Sensory-Based Interventions for Adults with Dementia and Alzheimer's Disease: A Scoping Review. Occup Ther Health Care. 2020 Jul;34(3):171-201. doi: 10.1080/07380577.2019.1608488. Epub 2019 May 8.
PubMed 31066598Hogg J, Cavet J, Lambe L, Smeddle M. The use of 'Snoezelen' as multisensory stimulation with people with intellectual disabilities: a review of the research. Res Dev Disabil. 2001 Sep-Oct;22(5):353-72. doi: 10.1016/s0891-4222(01)00077-4.
PubMed 11580163Burns I, Cox H, Plant H. Leisure or therapeutics? Snoezelen and the care of older persons with dementia. Int J Nurs Pract. 2000 Jun;6(3):118-26. doi: 10.1046/j.1440-172x.2000.00196.x.
PubMed 11249409Merrick J, Cahana C, Lotan M, Kandel I, Carmeli E. Snoezelen or controlled multisensory stimulation. Treatment aspects from Israel. ScientificWorldJournal. 2004 May 11;4:307-14. doi: 10.1100/tsw.2004.30.
PubMed 15167944Chitsey AM, Haight BK, Jones MM. Snoezelen: a multisensory environmental intervention. J Gerontol Nurs. 2002 Mar;28(3):41-9. doi: 10.3928/0098-9134-20020301-09.
PubMed 11913515Carvalho SC, Martins FS, Martins AN, Barbosa RC, Vicente SG. Effectiveness of Snoezelen in older adults with neurocognitive and other pathologies: A systematic review of the literature. J Neuropsychol. 2024 Jun;18(2):312-331. doi: 10.1111/jnp.12346. Epub 2023 Sep 21.
PubMed 37735859Seegers H, Serani I, Bogar M, Gei M, Baudet V, Witz L, Bouchard JP. [The Snoezelen approach in pain management in psychiatry]. Soins Psychiatr. 2019 Jan-Feb;40(320):35-40. doi: 10.1016/j.spsy.2018.11.008. French.
PubMed 30654878Chung JC, Lai CK, Chung PM, French HP. Snoezelen for dementia. Cochrane Database Syst Rev. 2002;2002(4):CD003152. doi: 10.1002/14651858.CD003152.
PubMed 12519587Sigal A, Sigal M. The Multisensory/Snoezelen Environment to Optimize the Dental Care Patient Experience. Dent Clin North Am. 2022 Apr;66(2):209-228. doi: 10.1016/j.cden.2021.12.001.
PubMed 35365274Alruwaili AN, Alruwaili MM, Ramadan OME, Ali SI, Shaban M. Nursing strategies for enhancing calm in older Arabs with dementia: integrating Snoezelen methods, aromatherapy, and personal items to reduce agitation. Geriatr Nurs. 2024 Sep-Oct;59:379-391. doi: 10.1016/j.gerinurse.2024.07.017. Epub 2024 Aug 10.
PubMed 39128143
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Calm in Arab Elderly With Dementia: Integrating Snoezelen Methods With Aromatherapy and Personal Items to Reduce Agitation
- ClinicalTrials.gov ID
- NCT06216275
- Acronym / sponsor ID
- sn/dm / Snoezelen_Demntia
- Keywords
- Dementia Care, Agitation in Elderly, Arab Elderly Dementia, Snoezelen Therapy, Aromatherapy in Dementia, Multi-sensory Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mostafa ShabanUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 Jan 2024 (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.
The goal of this clinical trial is to evaluate the effectiveness of integrating Snoezelen methods with aromatherapy and personal items in reducing agitation in Arab elderly individuals with dementia. The main questions it aims to answer are:
Does the combination of Snoezelen methods, aromatherapy, and the use of personal items significantly reduce agitation in elderly Arab patients with dementia compared to standard care practices? How do patients and caregivers perceive the impact of this integrated approach on the overall well-being and quality of life of the patients?
Participants in this study will:
Engage in sessions utilizing Snoezelen methods, a multi-sensory environment designed to deliver stimuli to various senses.
Receive aromatherapy treatments with selected scents known for their calming properties.
Be provided with personal items that are familiar and meaningful to them, to create a sense of comfort and security.
Detailed description
This clinical trial is centered on a novel approach to dementia care, specifically targeting the Arab elderly demographic. It uniquely combines three elements - Snoezelen therapy, aromatherapy, and the use of personal items - to address agitation, a common and challenging symptom in dementia patients.
Snoezelen Therapy Implementation:
Custom-designed Snoezelen rooms will be used, equipped with lights, colors, sounds, and textures to stimulate senses in a controlled manner.
Sessions will be tailored to individual patient needs and preferences, monitored by trained staff.
Aromatherapy Application:
Selection of aromas will be based on their known calming properties, with a focus on cultural relevance and acceptability in the Arab elderly population.
The method of delivery and duration of each aromatherapy session will be standardized to ensure consistency across the study.
Incorporation of Personal Items:
Patients will be encouraged to select personal items that hold significant emotional value or are tied to pleasant memories.
These items will be integrated into the therapy sessions to provide a sense of familiarity and emotional comfort.
Data Collection and Analysis:
Quantitative data on agitation levels will be gathered using established agitation scales, both pre- and post-intervention.
The study aims to provide a comprehensive evaluation of how this integrated approach can influence agitation in dementia, considering both statistical effectiveness and personal experiences. The outcome will contribute valuable insights into dementia care practices, particularly for the Arab elderly population, and may offer a template for culturally sensitive dementia care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Integrated Snoezelen-Aromatherapy-Personal Item TherapyParticipants receiving the integrated approach of Snoezelen therapy, aromatherapy, and the use of personal items. |
| Control Arm | No intervention | –Participants receiving standard care practices for dementia and agitation without the integrated approach. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: Participants must be 65 years to 90 years
- Diagnosis: Clinical diagnosis of dementia required.
- Ethnicity: Must be of Arab descent.
- Agitation Levels: Must show agitation signs based on a standardized scale.
- Cognitive Function: Adequate cognitive function for study participation, verified by standard assessment.
Key exclusion criteria (4 listed)
- Severe Medical Conditions: Individuals with severe medical conditions that could affect study participation or health.
- Advanced Dementia: Patients with very advanced dementia stages, unable to engage in study activities.
- Allergies: Known allergies to aromatherapy products used in the study.
- Recent Medication Changes: Significant changes in dementia medication regimen before the study.
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 |
|---|---|---|
| Integrated Snoezelen-Aromatherapy-Personal Item TherapyIntervention Description: This unique intervention combines three distinct therapeutic approaches specifically tailored for Arab elderly patients with dementia experiencing agitation. Snoezelen Therapy: Customized sessions in a Snoezelen environment - a specialized room designed to deliver controlled multi-sensory stimuli. This room features adaptable lighting, colors, sounds, and textures to provide a soothing and stimulating experience. Sessions are personalized based on each patient's response and preference, under the guidance of trained professionals. Aromatherapy: Carefully selected essential oils known for their calming properties are used in a culturally sensitive manner. These oils are diffused in the environment or used during individual sessions to provide a relaxing olfactory experience. The choice of oils and method of delivery are standardized | Behavioural | Intervention Arm |
Primary outcome
Reduction in Agitation Levels
Time frame: 4 weeks
The primary outcome measure is the reduction in agitation levels among the Arab elderly with dementia participating in the study. This will be quantitatively assessed using a validated agitation scale, such as the Cohen-Mansfield Agitation Inventory (CMAI) or a similar tool appropriate for dementia patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 31066598Smith BC, D'Amico M. Sensory-Based Interventions for Adults with Dementia and Alzheimer's Disease: A Scoping Review. Occup Ther Health Care. 2020 Jul;34(3):171-201. doi: 10.1080/07380577.2019.1608488. Epub 2019 May 8.
- Background: PubMed 11580163Hogg J, Cavet J, Lambe L, Smeddle M. The use of 'Snoezelen' as multisensory stimulation with people with intellectual disabilities: a review of the research. Res Dev Disabil. 2001 Sep-Oct;22(5):353-72. doi: 10.1016/s0891-4222(01)00077-4.
- Background: PubMed 11249409Burns I, Cox H, Plant H. Leisure or therapeutics? Snoezelen and the care of older persons with dementia. Int J Nurs Pract. 2000 Jun;6(3):118-26. doi: 10.1046/j.1440-172x.2000.00196.x.
- Background: PubMed 15167944Merrick J, Cahana C, Lotan M, Kandel I, Carmeli E. Snoezelen or controlled multisensory stimulation. Treatment aspects from Israel. ScientificWorldJournal. 2004 May 11;4:307-14. doi: 10.1100/tsw.2004.30.
- Background: PubMed 11913515Chitsey AM, Haight BK, Jones MM. Snoezelen: a multisensory environmental intervention. J Gerontol Nurs. 2002 Mar;28(3):41-9. doi: 10.3928/0098-9134-20020301-09.
- Background: PubMed 37735859Carvalho SC, Martins FS, Martins AN, Barbosa RC, Vicente SG. Effectiveness of Snoezelen in older adults with neurocognitive and other pathologies: A systematic review of the literature. J Neuropsychol. 2024 Jun;18(2):312-331. doi: 10.1111/jnp.12346. Epub 2023 Sep 21.
- Background: PubMed 30654878Seegers H, Serani I, Bogar M, Gei M, Baudet V, Witz L, Bouchard JP. [The Snoezelen approach in pain management in psychiatry]. Soins Psychiatr. 2019 Jan-Feb;40(320):35-40. doi: 10.1016/j.spsy.2018.11.008. French.
- Background: PubMed 12519587Chung JC, Lai CK, Chung PM, French HP. Snoezelen for dementia. Cochrane Database Syst Rev. 2002;2002(4):CD003152. doi: 10.1002/14651858.CD003152.
- Background: PubMed 35365274Sigal A, Sigal M. The Multisensory/Snoezelen Environment to Optimize the Dental Care Patient Experience. Dent Clin North Am. 2022 Apr;66(2):209-228. doi: 10.1016/j.cden.2021.12.001.
- Derived from this study: PubMed 39128143Alruwaili AN, Alruwaili MM, Ramadan OME, Ali SI, Shaban M. Nursing strategies for enhancing calm in older Arabs with dementia: integrating Snoezelen methods, aromatherapy, and personal items to reduce agitation. Geriatr Nurs. 2024 Sep-Oct;59:379-391. doi: 10.1016/j.gerinurse.2024.07.017. Epub 2024 Aug 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Snoezelen-Aromatherapy-Personal Item Therapy in people with Dementia and Agitation in Dementia, Including Alzheimer's Disease, run by Mostafa Shaban at 1 site in Egypt.
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 5 inclusion and 4 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 6 Feb 2024. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Agitation Levels (time frame: 4 weeks). 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 NCT06216275, which also lists 10 linked publications.
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 6 Feb 2024.