Determining the effect of acupressure on the self-efficacy of falling in the elderly
Design
A clinical trial of two parallel groups, single-blind, randomized by the random sequence method generated from the Randomization site will be conducted on 60 elderly patients.
Settings and conduct
After coordinating the visit days, the researcher, being present in the nursing home environment, will perform acupressure for the real acupressure intervention group and non-real massage for the sham group. In the first session, the demographic and FES questionnaire will be completed through interviews in both groups. Two groups receive massage at 4 points for 3 sessions of 11 minutes per week for four weeks. The massage will be done with fingertip pressure and in a semi-circle rotation in the clockwise direction.
Participants/Inclusion and exclusion criteria
1. Consent to participate in the study
2. Age 65 and above
3. A score of 7 and above from the AMT test
4. A score of 19 and above from FES questionnaire
5. Not having acute cognitive and mental disorders
6. Not having severe vision and hearing disorders
7. Not having acute neurological disorders, musculoskeletal disorders that disturb movement and balance, vestibular disorders and severe dizziness requiring medical care, cardiac and respiratory problems, and end-stage disease that may affect participation.
8. The ability to move independently or with an auxiliary device
9. The ability to communicate verbally and understand the Persian language
10. Not having wounds, fractures and lesions at the place of the intervention
11. Not having a parallel massage program
Intervention groups
The intervention group receives acupressure at Bai hui, Yin tang, Tai chong and Shen men pressure points. the sham group receives unreal massage at Feng fu, Cheng jiang, Yang lao and Da dun pressure points.
Main outcome variables
falls self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221002056074N1
Registration date:2022-10-09, 1401/07/17
Registration timing:registered_while_recruiting
Last update:2022-10-09, 1401/07/17
Update count:0
Registration date
2022-10-09, 1401/07/17
Registrant information
Name
Mahdieh Mohajer
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 6327
Email address
mohajerm992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on Falls Self-Efficacy in Older Adults: A Sham-Controlled Randomized Clinical Trial
Public title
The Effect of Acupressure on Older Adults Falls Efficacy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
65 years or older
A score of 7 and above from the AMT test
A score of 19 or more from the FES questionnaire
Ability to move independently or with an assistive device (walking aids)
The ability to communicate verbally and understand the Persian language
Exclusion criteria:
Having acute cognitive and mental disorders
Having severe vision and hearing impairments
Having acute neurological disorders, musculoskeletal disorders that impair movement and balance, vestibular disorders and severe dizziness requiring medical attention, cardiac and respiratory problems, and end-stage disease that may affect participation.
Having wounds, fractures and lesions at the place of intervention
Having a parallel massage program
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The random block method of four AABB, ABAB, BBAA, BABA prepared using the Randomization site will be used to allocate the research units to two groups. Preparation of blocks will be done before the start of sampling. The random sequence will be kept in a sealed envelope until the time of sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, two groups of elderly participants who will receive acupressure intervention will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Ibne-sina int., Taghiabad sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-08-02, 1401/05/11
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.060
Health conditions studied
1
Description of health condition studied
falling
ICD-10 code
R29. 6
ICD-10 code description
Tendency to fall because of old age or other unclear health problems
Primary outcomes
1
Description
The falls efficacy scale international (FES-I) score
Timepoint
Before the intervention, after the intervention in the fourth week
Method of measurement
The falls efficacy scale international (FES-I) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The massage receives pressure points in Bai hui, Yin tang, Tai chong and Shen men (respectively on the scalp, between the eyebrows, on the back of the foot and on the wrist). This intervention will be carried out during 4 weeks (12 sessions) and 3 times a week for 11 minutes (8 minutes massage of 4 points + 3 minutes rest between pressure points 1-2, 2-3 and 3-4).
Category
Treatment - Other
2
Description
Control group: In sham or unreal acupressure group, massage will be performed on Feng fu, Cheng jiang, Yang lao and Da dun pressure points (back of the neck, on the chin, on the back of the wrist and on the big toe). This intervention will be carried out during 4 weeks (12 sessions) and 3 times a week for 11 minutes (8 minutes massage of 4 points + 3 minutes rest between pressure points 1-2, 2-3 and 3-4).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farzangan nursing home
Full name of responsible person
sharifi
Street address
No. 232, 31 Azadi corner, West Ibn Sina st., Esteghlal sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3606 7946
Email
nms.pr@mums.ac.ir
2
Recruitment center
Name of recruitment center
Bahar nursing home
Full name of responsible person
Maryam Haqi
Street address
No. 33, Laleh 8 st., 17 Fakuri St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3866 4576
Email
nms.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
afsaneh kalani
Street address
Nursing and Midwifery Faculty, Ibne-sina int., Taghiabad sq., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@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
Mahdieh Mohajer
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Ibne-sina int., Taghiabad sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mohajerm992@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Salehian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Ibne-sina int., Taghiabad sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
salehianmr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Mohajer
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Ibne-sina int., Taghiabad sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mohajerm992@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the fall self-efficacy score, and part of the research variables, such as osteoporosis, history of falls, smoking, etc., will be shared.
When the data will become available and for how long
The access period starts from 1402
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Those who need to review the literature and have results and variables similar to this research.
From where data/document is obtainable
To receive, refer to the postal address mohajerm992@mums.ac.ir.
What processes are involved for a request to access data/document
After providing explanations and justifications for receiving the data files, the data will be sent via email.