How to Bathe a Person With Dementia? A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia
Primary Purpose
Patient Engagement, Behavioral Symptoms
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Bathing technique based on Basale Stimulation
Sponsored by

About this trial
This is an interventional treatment trial for Patient Engagement
Eligibility Criteria
Inclusion Criteria:
- 55 years old or older
- Moderate or severe dementia (GDS 5 or higher)
- Long term care patients
- Dependent for bathing
Exclusion Criteria:
- Mild Cognitive Impairment or dementia with GDS 4 or lower.
- Need 2 or more people for assisted bathing
- Independence for showering
Sites / Locations
- Universidad de Salamanca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bathing technique based on Basale Stimulation
Traditional bathing technique
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05353049
First Posted
March 28, 2022
Last Updated
April 28, 2022
Sponsor
University of Salamanca
Collaborators
National Reference Centre for Alzheimer's and Dementia Care (CREA), Spain
1. Study Identification
Unique Protocol Identification Number
NCT05353049
Brief Title
How to Bathe a Person With Dementia? A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia
Official Title
A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
Collaborators
National Reference Centre for Alzheimer's and Dementia Care (CREA), Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Engagement, Behavioral Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bathing technique based on Basale Stimulation
Arm Type
Experimental
Arm Title
Traditional bathing technique
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Bathing technique based on Basale Stimulation
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.
Primary Outcome Measure Information:
Title
Frequency of Engagement Behaviour assessed with the Involvement Register (RIE)
Description
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.
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Through study completion, an average of 2 years
Other Pre-specified Outcome Measures:
Title
Intensity 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)
Description
Assessment of the intensity of behavioural symptoms presented during bathing (1-3 likert scale. 1: low intensity, 2: medium intensity, 3: high intensity of behavioural symptoms during bathing).
Higher scores (higher intensity of behaviour symptoms) mean a worse outcome. If behavioural symptoms can not be eliminated, the aim is is to reduce intensity of those symptoms.
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
55 years old or older
Moderate or severe dementia (GDS 5 or higher)
Long term care patients
Dependent for bathing
Exclusion Criteria:
Mild Cognitive Impairment or dementia with GDS 4 or lower.
Need 2 or more people for assisted bathing
Independence for showering
Facility Information:
Facility Name
Universidad de Salamanca
City
Salamanca
State/Province
Castilla Y León
ZIP/Postal Code
37005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
How to Bathe a Person With Dementia? A Bathing Intervention Based on Basale Stimulation® for People With Moderate to Severe Dementia
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