Plain English Summary
Background and study aims
Dementia is a common condition that causes a decline in memory. Dementia can reduce someone’s ability to perform their normal daily activities, causing discomfort, anxiety, restlessness, and wandering. The risk of dementia increases with age, with most cases reported in patients over 65. Therapeutic Touch (TT) is a type of alternative therapy based on the belief that a person and his/her illness are reflected in an imbalance of their energy field. Imbalances are restored using a technique in which a therapist uses their hands to direct human energy for healing purposes. TT is becoming more popular due to its role in improving symptoms such as pain, sleep disturbances, depression, stress and anxiety in patients. The goal of this study is to explore as to whether participants who are suffering from cognitive (mental processing) impairment, and display symptoms of dementia responsive behaviors (RBD) like depression, stress and anxiety, show a response to TT. The study will also look at whether TT improves therapeutic relationships and allow the upkeep of a form of communication which may not be possible otherwise in patients with dementia and become an alternative treatment to medication.
Who can participate?
Older adults living in the SageCare Long Term Care Dementia Institution who have dementia and low mood
What does the study involve?
Participants are allocated to one of three groups. Those in the first group take part in TT on their neck and the shoulder. Those in the second group receive a mimic treatment that resembles TT (simple non-Therapeutic Touch). Those in the last group will be the control group and they take part in regular routine care. Participant’s behaviour is monitored five days pre-treatment and five days post-treatment.
What are the possible benefits and risks of participating?
The possible benefits of TT are the improvement of behavioural symptoms of dementia such as agitation, wandering, restlessness, and vocalizations (making sounds that are not works), as well as other symptoms that may contribute to RBD such as pain, sleep disturbances, depression, stress and anxiety will be investigated. There are no known risks to participating in the study.
Where is the study run from?
SageCare Long Term Care (Canada)
When is the study starting and how long is it expected to run for?
January 2017 to January 2019
Who is funding the study?
The College of Family Physicians Canada (Canada)
Who is the main contact?
Dr. Helen Senderovich
hsenderovich@baycrest.org
Trial website
Contact information
Type
Public
Primary contact
Dr Helen Senderovich
ORCID ID
http://orcid.org/0000-0003-0449-7029
Contact details
Baycrest Health Sciences
3560 Bathurst
Toronto
M6A 2E1
Canada
Type
Scientific
Additional contact
Dr Helen Senderovich
ORCID ID
http://orcid.org/0000-0003-0449-7029
Contact details
Baycrest Health Sciences
3560 Bathurst
Toronto
M6A 2E1
Canada
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Therapeutic Touch in the management of Responsive Behavior in patients with Dementia
Acronym
TT in RBD
Study hypothesis
Therapeutic touch can be an effective non-pharmacological approach for the management of responsive behavior in patients with dementia with no negative sequelae.
Ethics approval
Research Ethics Board Baycrest Health Sciences, 24/03/2017, ref: 16-56
Study design
Single centre double-blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Dementia
Intervention
Participants will be randomly divided into three groups. Each group will have around 25 participants.
Experimental Group: Will receive Therapeutic touch on the neck and the shoulder, twice a day. The participants receives therapeutic touch from a practitioner who will sense the imbalance in their energy field and use their hands to direct human energy to those areas for healing purposes. In regards to the administration of Therapeutic Touch, if the patient is awake, there would be a touch option available, defined as a very light touch over the feet, hands and shoulders. The Therapeutic Touch practitioner would place their hands over the body of the patient, starting from either the head or the shoulder, and making their way to the feet. The sessions are broken down into 4 phases. The assessment phase assesses the patient’s energy field symmetry, since the purpose of Therapeutic Touch is to equalize the field. The clearing phase is about re-balancing the energy field. During the modulation phase, the Therapeutic Touch practitioner checks to see if there are any more imbalances and then focuses directly on those. Lastly, the reassessment phase is to see if the body feels different in any way than it did originally.
Non-Therapeutic Touch Group: Will receive a mimic treatment (simple non-Therapeutic Touch) that resembles Therapeutic touch, twice a day.
Placebo Group: Will receive regular routine care.
Each participant will require an approximately 30 minutes per session to administer and properly observe the effect of Therapeutic Touch. In addition, each participant’s behavior will be observed every 20 minutes, for 10 hours a day during the five pre-intervention and five post- intervention days by trained and blinded observers.
Information collected during the Therapeutic Touch treatment session will include the session date, patient’s goals for the treatment, patient response, and practitioner observations. All observers will be trained and masked during the study. Thus, they are not told the purpose of the study and the type and timing of the intervention. They will monitor and record each participant’s behavior as per schedule during the five pre-intervention and five post- intervention days.
A follow up will take place 2 weeks after completion of the study. During the follow up, the observers will look to see if there is stability in symptoms control. They will look to see if an improvement in responsive behaviour(s) is maintained throughout the post-interventions. Moreover, observers will look to see if the participants have better symptoms control such as a decrease in agitation, restlessness, vocalizations, and wandering, as well as an improvement in pain control, sleep disturbances, and anxiety. Observers will also look to see if patients seem to be relaxed, and have established interpersonal relationships with the staff which will allow for better adherence with the care.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Behaviour is assessed by the Modified Agitated Behaviour Rating Scale (ABRS) at baseline and five days post intervention.
Secondary outcome measures
Ability to form and establish interpersonal relationships is assessed by staff observations at baseline and five days post intervention.
Overall trial start date
02/01/2017
Overall trial end date
30/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Between the ages of 65 and 95, who have cognitive impairment and exhibit behavior symptoms of dementia
2. Reside in the SageCare Long Term Care Dementia Institution
3. Diagnosis of dementia according to the DSM IV criteria (confirmed by a physician)
4. Mini Mental state exam (MMSE) score < 20
5. Stabilized on medications for at least one month
6. Will remain on the unit for the duration of the study
7. Had resided on the unit for at least 2 months
8. Has multiple comorbidities
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
3 clusters, approximately 25 participants in each cluster, total 70-75 patients
Total final enrolment
49
Participant exclusion criteria
1. Patients who have an acute psychiatric or physical illness
2. Patients who were diagnosed with dementia within a 3 month period
Recruitment start date
01/02/2017
Recruitment end date
01/01/2019
Locations
Countries of recruitment
Canada
Trial participating centre
Sage Care
147 Elder St
North York
M2M 4G2
Canada
Funders
Funder type
Not defined
Funder name
The College of Family Physicians Canada (CFPC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
All findings are published in a manuscript form or accepted for publication in a high-impact peer reviewed journal by this time. A poster will also be created by this date.
IPD Sharing Plan:
The extracted from electronic medical records and collected from the observations data will be de-identified and stored in the password protected electronic file on a secure computer server at the participating site.
Intention to publish date
30/01/2021
Participant level data
Stored in repository
Basic results (scientific)
Publication list