Determining the effect of Snozelen therapy on the care dependence of the elderly with Parkinson's.
Design
Clinical trial has two groups of intervention and control, with parallel groups, single blind, randomized with blocking on 70 patients. Randomization site is used for randomization.
Settings and conduct
This two-group randomized clinical trial study will be performed on 70 elderly people with Parkinson's disease referred to vertical neurology clinics who are willing to participate and meet the inclusion criteria. The samples are randomly divided into control and intervention groups. Before the intervention, the questionnaire will be filled in. Patients enter the room in groups of three. Then the intervention of Snoezelen begins. The olfactory stimulant of mint essential oil is spread in the environment. Then we play the visual and auditory stimulus .Thus, they receive stimuli for 25 minutes, and in the last 5 minutes, the auditory and visual stimuli are turned off and they only take deep breaths.
Participants/Inclusion and exclusion criteria
Inclusion criteria: desire to participate in the study; age over 60 with Parkinson's in the first and second stages; lack of cognitive problem with MMSE tool; absence of severe disturbances in the senses of smell, sight and hearing in the examination; not having an active mental illness.
Exclusion criteria: unwillingness to participate in further study; death; absence from 1 session out of 8 sessions of Snoezelen therapy; change of disease stage to end stage; incidence of cognitive impairment; activation of mental disorder.
Intervention groups
In addition to medication and the center's standard training, the intervention team receives olfactory, visual, and auditory stimuli in the snooze rooms.
Main outcome variables
Psychological and physical dimensions of care dependence
General information
Reason for update
Acronym
MSE
IRCT registration information
IRCT registration number:IRCT20220209053981N1
Registration date:2022-02-24, 1400/12/05
Registration timing:registered_while_recruiting
Last update:2022-02-24, 1400/12/05
Update count:0
Registration date
2022-02-24, 1400/12/05
Registrant information
Name
Fatemeh Yousefli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3763 3377
Email address
youseflif992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-12, 1400/11/23
Expected recruitment end date
2022-04-02, 1401/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of multi-sensorial Environment (Snoezelen Therapy) On The Care Dependence Of The Elderly With Parkinson Disease.
Public title
The effect of multi-sensory stimuli on dependence on the elderly caregiver
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly desire to participate in the study
Elderly people over 60 with Parkinson's in the first and second stages
Lack of cognitive problems with MMSE tools
Absence of severe disturbances in the senses of smell, sight and hearing in the examination
No active mental illness
Exclusion criteria:
Reluctance to participate in further study
Participant's death
Absence from 1 session out of 8 sessions of Snoezelen therapy
Change the disease stage to end stage
Incidence of cognitive impairment
Activation of mental disorder
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is available. Members are then randomized based on blockchain. This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization, and at certain points the number of participants in each group is equal. For this method, the volume of each block must first be determined.(Example of a quadruple block). Then write a list of blocks and assign numbers to them ((1)AABB - (2)ABAB -(3)ABBA -(4)BBAA -(5) BABA -(6) BAAB ) Then select random numbers between one and 6 (Eg 1 4 5, etc.) and finally specify the treatment allocation list based on previous random numbers (AB AABB-BBAA-BABA-).
The method of four random blocks (AABB, ABAB, BBAA, BABA,) which have been prepared using the Randomization site will be used to assign research units to two groups. The blocks will be prepared before sampling begins. Random sequences will be stored in closed-door envelopes until sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants were randomly grouped and blinded. Participants become blind, so that people have no knowledge of the group to which they are assigned.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Mashhad University of medical science
Street address
Faculty of Nursing and Midwifery Mashhad, Ebn Sina St., Doctora Blvd..
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-02-10, 1400/11/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.088
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Care dependency score changes
Timepoint
At the beginning of the study before the intervention and after 8 sessions (8 weeks)
Method of measurement
Care Dependence Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After determining the research units and preparing the snow room, the researcher will be fully acquainted with the snow room, the available equipment and how they work. After the researcher is fully acquainted with snozlen, the patients of the intervention group will be present in the hospital environment after coordination on the days of periodic visits or with the coordination and request of the patient. Patients then enter the room in groups of three. Preparations before starting Snoozelen: To reduce distraction and focus more, the cell phone should not be used in the room environment and we ask participants to turn off their cell phones and if they need a hygienic service or may be in If they need a session, be sure to go before starting the intervention.Before starting, we explain the snoozelen steps to the participants and answer any questions we may have, as well as reassuring them that they can leave the room whenever they want, thus showing them that they are completely on the environment. They have control. Now the intervention of snozlen begins. The olfactory stimulant of essential oil (5 drops of mint and one to two drops of water from Nicochemical Company) We spread the essential oil burning device in the environment and ask the participants to close their eyes and take four breaths 1-4-2 (2 seconds of inhalation). , 4 seconds of respiratory arrest, 1 second of exhalation) to reduce anxiety. Then we play the visual and auditory stimulus (a relaxing clip selected in consultation with a neurologist). During the broadcast, the researcher pays attention to each person's reaction and is recorded in the researcher's observation checklist (for example, the clip of the first session fascinated or disliked participant A). Thus, receiving 25 minutes of stimuli and the last 5 minutes of auditory and visual stimuli are turned off and the participant focuses again on the olfactory stimulus, and we ask the patient to breathe 1-4-2 again and to express his opinion and expectations. Tell the first session. Finally, we thank the participants and end the meeting. Each session provides them with different visual and auditory stimuli. After 8 sessions, the care dependency questionnaire is completed again.
Category
Rehabilitation
2
Description
Control group: Members of this group receive standard care only under the supervision of their physician and complete the care dependency questionnaire scale twice in 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaeem hospital
Full name of responsible person
Seyyed Mahdi Hasani
Street address
Ahmadabad Blvd, Mashhad,Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Haji Abadi
Street address
Ebn Sina Ave, Doctora Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
IT@mums.ac.ir
Web page address
https://nurse.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Yousefli
Position
MSc student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery Mashhad, Ebn Sina St., Doctora Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9197968280
Phone
+98 51 3859 1511
Email
farnazyousefli98@gmail.com
Web page address
https://nurse.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Valizade
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwiffery, Ebn Sina Ave., Doctora Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
valizadehn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Yousefli
Position
MSc of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery Mashhad, Ebn Sina St., Doctora Blvd,.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
farnazyousefli98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only data related to the main outcome can be shared.
When the data will become available and for how long
6 months later print results
To whom data/document is available
Only researchers working in scientific institutes can access this data.
Under which criteria data/document could be used
Responsible author for the purpose of research in connection with this treatment
From where data/document is obtainable
Responsible author: valizadehn@mums.ac.ir
First author: farnazyousefli98 @ gmailcom
What processes are involved for a request to access data/document
After approving the title and getting the code of ethics and conducting the necessary studies with the research team, it will be sent to the applicant.