Patient EngagementNCT05353049
How to Bathe a Person With Dementia? A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia
A study testing Bathing technique based on Basale Stimulation in people with Patient Engagement and Behavioral Symptoms, run by University of Salamanca at 1 site in Spain.
Trial summary
Brief summary Resisted behaviours that occur during showering of People with Dementia (PwD) cause greater discomfort for caregivers and may occur as a result of embarrassment and shame that the person with dementia may be experiencing or even due to a moment of confusion or anxiety. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Patient Engagement, Behavioral Symptoms
- What is being tested?
- Bathing technique based on Basale Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 31 May 2023
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years old or older
- Moderate or severe dementia (GDS 5 or higher)
- Long term care patients
- Dependent for bathing
Who cannot join
- Mild Cognitive Impairment or dementia with GDS 4 or lower.
- Need 2 or more people for assisted bathing
- Independence for showering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia
Brief summary Resisted behaviours that occur during showering of People with Dementia (PwD) cause greater discomfort for caregivers and may occur as a result of embarrassment and shame that the person with dementia may be experiencing or even due to a moment of confusion or anxiety.
Therefore, it is considered particularly relevant and necessary to provide information and strategies to caregivers of PwD in order to manage the behavioural alterations produced during the shower.
Read more
One of the strategies currently used in clinical practice to improve the relationship between caregivers and users is the implementation of the Basale stimulation® concept.
The stimuli applied from Basale Stimulation® are related to 3 basic areas of development: somatic, vestibular and vibrational. In relation to the development of the showers, they will be carried out from the application of relaxing somatic modelling connected to the somatic area.
The aim of this study is to analyse the efficacy of an intervention based on the relaxing somatic modelling technique, framed within the Basale Stimulation® concept, to reduce behavioural disturbances and increase the involvement of the person with moderate to severe dementia during assisted showering.
The main caregivers of the PwD, who meet the inclusion criteria will be contacted by sending a study information sheet and an informed consent form. All family members will receive a call to clarify the concepts explained and the study methodology to be carried out.
The grooming sessions of all users whose relatives have signed the informed consent form, will be videotaped and a trained technician will fill in the questionnaires for each session based on the analysis of the videos of each intervention.
Six intervention sessions will be carried out with each user. An alternating treatment design will be used, applying condition A or B randomly and then counterbalancing. Condition A corresponds to a traditional shower according to the long-term care bathing and grooming protocol and condition B corresponds to the use of relaxing somatic modelling within Basale Stimulation®.
The first result obtained will be an increase in the appearance and frequency of behaviours that increase the engagement of the PwD and a decrease in the appearance and frequency of disengagement behaviours during the shower activity in the Basale Stimulation® application sessions. This result will be measured with the Involvement Register (RIE) (García-Soler et al., 2014), adding the measure of frequency of involvement behaviours on a likert scale.
The second expected outcome will be the decrease in the occurrence, frequency and intensity of behavioural disturbances during the Basale Stimulation®-based intervention showers. This outcome will be measured with a questionnaire based on the Neuropsychiatric Inventory Questionnaire (NPI-Q)(Boada et al., 2002) and the Agitated Behavior in Dementia scale (ABID) (Logsdon et al., 1999), recording the number of times a disruptive behaviour appears, the frequency with which it appears during the shower, and the intensity of the behaviour on a Likert scale.
In addition, the user's functional status measured with the Barthel Index, his cognitive status measured with the Mini-Mental State Examination and his behaviour through the Agitation Inventory of the Elderly will be taken into account.
Intervention description The relaxing somatic modelling technique will be applied, framed within the concept of Basal Stimulation®. To do this, the user remains seated and the parts of the body that are not being washed at that moment are covered with a towel, favouring the preservation of the user's privacy. The user is lathered up with soft mittens previously moistened with lukewarm water and lathered up. This process shall be carried out starting from the shoulder in a proximal to distal direction on the upper limbs, lower limbs and trunk (taking into account the sagittal anatomical plane) and in a cephalic to caudal direction (taking into account the transverse anatomical plane).
Subsequently, rinsing is carried out following the same guidelines as described above, using moistened soft mittens. Finally, intimate hygiene is performed with a disposable soapy sponge and the soap is rinsed off again with moistened soft terrycloth mittens. Throughout the whole process, the activity is explained to the user.
- Conditions
- Patient Engagement, Behavioral Symptoms
- Being tested
- Bathing technique based on Basale Stimulation
- Medical subject headings
- Patient Participation, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bathing technique based on Basale StimulationBehavioural
The relaxing somatic modelling technique will be applied, framed within the concept of Basal Stimulation®. To do this, the user remains seated and the parts of the body that are not being washed at that moment are covered with a towel, favouring the preservation of the user's privacy. The user is lathered up with soft mittens previously moistened with lukewarm water and lathered up. This process shall be carried out starting from the shoulder in a proximal to distal direction on the upper limbs, lower limbs and trunk (taking into account the sagittal anatomical plane) and in a cephalic to caudal direction (taking into account the transverse anatomical plane).
Subsequently, rinsing is carried out following the same guidelines as described above, using moistened soft mittens. Finally, intimate hygiene is performed with a disposable soapy sponge and the soap is rinsed off again with moistened soft terrycloth mittens. Throughout the whole process, the activity is explained to the user.
| Study group | Role | What they receive |
|---|---|---|
| Bathing technique based on Basale Stimulation | Experimental | Not described Receives: Behavioral: Bathing technique based on Basale Stimulation |
| Traditional bathing technique | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Engagement Behaviour assessed with the Involvement Register (RIE)
Assessment of the frequency of engagement behaviour during bathing (1-5 likert scale: "1" meaning a lower frequency of engagement behavioural while "5" means a higher frequency of engagement behaviour during bathing).
Higher scores (higher frequency of engagement behaviour) mean a better outcome.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Presence and frequency of behavioural symptoms assessed with the a Behavioral questionnaire based on the Neuropsychiatric Inventory Questionnaire (NPI-Q) and the Agitated Behavior in Dementia scale (ABID)
Evaluation of the presence and frequency of behavioural symptoms during bathing (1-5 likert scale: "1" meaning lower frequency of behavioural symptoms while "5" means a higher frequency of behavioural symptoms during bathing).
Higher scores (higher frequency of behaviour symptoms) mean a worse outcome. The aim is is to reduce the frequency or eliminate behaviour symptoms.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Nov 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- National Reference Centre for Alzheimer's and Dementia Care (CREA), Spain
- Responsible party
- Principal investigator, Jaime Unzueta Arce, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353049
- Sponsor's protocol ID
- Basale Stimulation bathing
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia
- ClinicalTrials.gov ID
- NCT05353049
- Acronym / sponsor ID
- Basale Stimulation bathing
- Conditions
- Patient Engagement, Behavioral Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- National Reference Centre for Alzheimer's and Dementia Care (CREA), Spain
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 29 Apr 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.
Brief summary Resisted behaviours that occur during showering of People with Dementia (PwD) cause greater discomfort for caregivers and may occur as a result of embarrassment and shame that the person with dementia may be experiencing or even due to a moment of confusion or anxiety.
Therefore, it is considered particularly relevant and necessary to provide information and strategies to caregivers of PwD in order to manage the behavioural alterations produced during the shower.
One of the strategies currently used in clinical practice to improve the relationship between caregivers and users is the implementation of the Basale stimulation® concept.
The stimuli applied from Basale Stimulation® are related to 3 basic areas of development: somatic, vestibular and vibrational. In relation to the development of the showers, they will be carried out from the application of relaxing somatic modelling connected to the somatic area.
The aim of this study is to analyse the efficacy of an intervention based on the relaxing somatic modelling technique, framed within the Basale Stimulation® concept, to reduce behavioural disturbances and increase the involvement of the person with moderate to severe dementia during assisted showering.
The main caregivers of the PwD, who meet the inclusion criteria will be contacted by sending a study information sheet and an informed consent form. All family members will receive a call to clarify the concepts explained and the study methodology to be carried out.
The grooming sessions of all users whose relatives have signed the informed consent form, will be videotaped and a trained technician will fill in the questionnaires for each session based on the analysis of the videos of each intervention.
Six intervention sessions will be carried out with each user. An alternating treatment design will be used, applying condition A or B randomly and then counterbalancing. Condition A corresponds to a traditional shower according to the long-term care bathing and grooming protocol and condition B corresponds to the use of relaxing somatic modelling within Basale Stimulation®.
The first result obtained will be an increase in the appearance and frequency of behaviours that increase the engagement of the PwD and a decrease in the appearance and frequency of disengagement behaviours during the shower activity in the Basale Stimulation® application sessions. This result will be measured with the Involvement Register (RIE) (García-Soler et al., 2014), adding the measure of frequency of involvement behaviours on a likert scale.
The second expected outcome will be the decrease in the occurrence, frequency and intensity of behavioural disturbances during the Basale Stimulation®-based intervention showers. This outcome will be measured with a questionnaire based on the Neuropsychiatric Inventory Questionnaire (NPI-Q)(Boada et al., 2002) and the Agitated Behavior in Dementia scale (ABID) (Logsdon et al., 1999), recording the number of times a disruptive behaviour appears, the frequency with which it appears during the shower, and the intensity of the behaviour on a Likert scale.
In addition, the user's functional status measured with the Barthel Index, his cognitive status measured with the Mini-Mental State Examination and his behaviour through the Agitation Inventory of the Elderly will be taken into account.
Intervention description The relaxing somatic modelling technique will be applied, framed within the concept of Basal Stimulation®. To do this, the user remains seated and the parts of the body that are not being washed at that moment are covered with a towel, favouring the preservation of the user's privacy. The user is lathered up with soft mittens previously moistened with lukewarm water and lathered up. This process shall be carried out starting from the shoulder in a proximal to distal direction on the upper limbs, lower limbs and trunk (taking into account the sagittal anatomical plane) and in a cephalic to caudal direction (taking into account the transverse anatomical plane).
Subsequently, rinsing is carried out following the same guidelines as described above, using moistened soft mittens. Finally, intimate hygiene is performed with a disposable soapy sponge and the soap is rinsed off again with moistened soft terrycloth mittens. Throughout the whole process, the activity is explained to the user.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bathing technique based on Basale Stimulation | Experimental | Behavioral: Bathing technique based on Basale Stimulation |
| Traditional bathing technique | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 55 years old or older
- Moderate or severe dementia (GDS 5 or higher)
- Long term care patients
- Dependent for bathing
Key exclusion criteria (3 listed)
- Mild Cognitive Impairment or dementia with GDS 4 or lower.
- Need 2 or more people for assisted bathing
- Independence for showering
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 |
|---|---|---|
| Bathing technique based on Basale StimulationThe relaxing somatic modelling technique will be applied, framed within the concept of Basal Stimulation®. To do this, the user remains seated and the parts of the body that are not being washed at that moment are covered with a towel, favouring the preservation of the user's privacy. The user is lathered up with soft mittens previously moistened with lukewarm water and lathered up. This process shall be carried out starting from the shoulder in a proximal to distal direction on the upper limbs, lower limbs and trunk (taking into account the sagittal anatomical plane) and in a cephalic to caudal direction (taking into account the transverse anatomical plane). Subsequently, rinsing is carried out following the same guidelines as described above, using moistened soft mittens. Finally, intimate hygiene is performed with a disposable soapy sponge and the soap is rinsed off again with moistened soft terrycloth mittens. Throughout the whole process, the activity is explained to the user. | Behavioural | Bathing technique based on Basale Stimulation |
Primary outcome
Frequency of Engagement Behaviour assessed with the Involvement Register (RIE)
Time frame: Through study completion, an average of 2 years
Assessment of the frequency of engagement behaviour during bathing (1-5 likert scale: "1" meaning a lower frequency of engagement behavioural while "5" means a higher frequency of engagement behaviour during bathing). Higher scores (higher frequency of engagement behaviour) mean a better outcome.
1 secondary outcome
Presence and frequency of behavioural symptoms assessed with the a Behavioral questionnaire based on the Neuropsychiatric Inventory Questionnaire (NPI-Q) and the Agitated Behavior in Dementia scale (ABID)
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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 Bathing technique based on Basale Stimulation in people with Patient Engagement and Behavioral Symptoms, run by University of Salamanca at 1 site in Spain.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 27 Mar 2026. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of Engagement Behaviour assessed with the Involvement Register (RIE) (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2026.