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The effect of palliative care (Namaste) on quality of life, pain, anxiety in elderly patients with dementia living in Nursing homes

Protocol summary

Summary
The aim of this study was to investigate the effect of Palliative care on quality of life, severity of pain and anxiety in elderly patients with Alzheimer's disease. This non-randomized clinical trial is a pre-and post-group clinical trial. Individuals with Alzheimer's who are able to co-operate with and speak and are willing to participate in the project can enter the study. The number of samples is 25 people selected by census method. An individualized care program is used to increase the interpersonal interactions and connect more. Sensory and tactile stimulation methods are also used to improve the quality of life of Alzheimer's elderly. Before the research begins for carers and families interested in participating in the research, the workshop will be held by the researcher. This program will be done 2 hours a day and 4 days a week for 6 months in a given space. This space consists of a quiet room with a comfortable chair with a little sensory stimulus, low light, lavender fragrance and music that includes relaxed and familiar songs and tunes that are appreciated by all the participants in the research. The researcher welcomed the patients and called them to the room with soft oils, gently touching her hands and massage her. In each session, about two hours (from 10:00 noon), some of the activities of the patient's interest, such as massage, memory, painting, drinking or personal care, such as combing hair or washing the face, are done. The family or carers are asked to determine the type of activity that the patient likes. Dolls will also be used to stimulate sensation. These dolls are similar to young children who are associated with the presence of children or grandchildren. Pictures that reflect the weather, season or holiday are shown to them. These activities are not intended to satisfy physical needs, but to attract concentration and sense of enjoyment

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122031489N1
Registration date: 2017-11-19, 1396/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
zahra amrollah majdabadi
Name of organization / entity
Tehran university of medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 61054209
Email address
afsaneha1358@gmail.com
Recruitment status
Recruitment complete
Funding source
University research project
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of palliative care (Namaste) on quality of life, pain, anxiety in elderly patients with dementia living in Nursing homes
Public title
The effect of palliative care nursing (Namaste) on elderly patients with dementia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Suffering from Alzheimer's disease؛ to be able to talk and have the ability to participate in the study Exclusion criteria: Non-participation in meetings for 3 weeks (12 sessions)
Age
From 40 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Eastern Nusrat Street, Tawhid Square, Postal Code: 1419733171
City
Tehran
Postal code
Iran
Approval date
2016-11-15, 1395/08/25
Ethics committee reference number
1395.1041

Health conditions studied

1

Description of health condition studied
Alzheimer
ICD-10 code
G30.9
ICD-10 code description
Alzheimer disease, unspecified

Primary outcomes

1

Description
Quality of Life
Timepoint
Before intervention and 6 months after intervention
Method of measurement
QUALITY OF LIFE IN LATE-STAGE DEMENTIA (QUALID) SCALE

2

Description
Anxiety
Timepoint
Before intervention and 6 months after intervention
Method of measurement
questionnaire, Hamilton Anxiety Rating Scale (HAM-A)

3

Description
pain
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Pain Assessment Checklist for Seniors with Limited Ability to Communicate-II

4

Description
Neuropsychological symptoms
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Neuropsychiatric Inventory – Nursing Home

Secondary outcomes

empty

Intervention groups

1

Description
The Namaste Care intervention is guided by concepts of person-centered care and maintaining a sense of ‘personhood’ within a palliative approach to dementia care. It was designed for those with dementia, and uses a high sensory and touch approach. Namaste Care provides an alternative to task-oriented care by creating meaningful activities, gentle touch for those ‘silent’ residents who are nearing death, often neglected and ‘stuck in their rooms . It runs 5 days/week 2 hours/day. In our study, we will use dedicated rooms for Namaste Care that are quiet and within a high sensory yet calming environment. Family involvement will be encouraged; they can participate in any activities that they prefer. (e.g., applying hand cream, brushing hair, assisting with nourishments). In the Namaste room, lighting is subdued, soothing music is played and the scent of lavender permeates the room. Residents are positioned in a comfortable reclining chair. In Namaste Care, food and liquids are offered by Carers, family members, or volunteers as both a pleasurable activity and a way to keep residents nourished and hydrated. About 20 minutes before lunch, the residents need to be stimulated to prepare for leaving the room and having a meal. The lights are turned up, music is livelier and items that reflect the weather, season or holiday will be shown to them.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Rehabilitation and Maintenance of Tawhid Elderly
Full name of responsible person
Majdabadi
Street address
no 137, Zahedi avenue, Tohid Square, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology of Tehran University of Medical Sciences
Full name of responsible person
Mrs kardan
Street address
Corner of Quds Street, Keshavarz Blvd, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing & Midwifery,Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Zahra Amrollah Majdabadi
Position
mentor
Other areas of specialty/work
Street address
Nosrat st, Tohid sq, Tehran, IRAN, Postal code: 141973317
City
Tehran
Postal code
Iran
Phone
+98 21 6105 4209
Fax
Email
afsaneha1358@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing & Midwifery,Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Nasriv Nikpeyma
Position
phd in nursing
Other areas of specialty/work
Street address
Nosrat st, Tohid sq, Tehran, IRAN, Postal code: 141973317
City
Tehran
Postal code
Iran
Phone
+98 21 6105 4207
Fax
Email
nikpeyma@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing & Midwifery,Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Zahra Amrollah majdabadi
Position
mentor
Other areas of specialty/work
Street address
Nosrat st, Tohid sq, Tehran, IRAN, Postal code: 141973317
City
Tehran
Postal code
IRAN
Phone
+61 54209
Fax
Email
afsaneha1358@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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