Determining the effect of acupressure on the anxiety, depression, and stress of main family caregivers of stroke patients.
Design
This study is a clinical trial with a control group, with parallel groups, single-blind, randomized with a table of random numbers, a sample size of 96 people.
Settings and conduct
Depression, anxiety, and stress are common problems for primary care patients with stroke. Interventions are necessary to improve these complications.96 participants will be randomly assigned to two groups according to inclusion criteria. In the intervention group, the acupressure will be applied at Yintang and Shenmen acupoints for one month. In the sham group, acupressure will be applied at CV24 and TB5 acupoints for one month. DASS42 questionnaire will be completed before and one day after the intervention. The data analyst will not be aware of the groups and the type of intervention in each group. Blinding will be done by coding the questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 60 years, Ability to read and write.
Exclusion criteria: Lack of physical ability, lack of desire to continue participating in research, Change the main caregiver.
Intervention groups
Intervention group: Participants in this group will press HT7 and GV29 acupoints. The intervention will be performed every morning for 15 minutes (5 minutes on each hand and 5 minutes on the third eye) for one month.
Sham Group: The CV24 and TB5 acupoints will be pressed.
Main outcome variables
Depression; Anxiety; Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190515043601N6
Registration date:2020-05-06, 1399/02/17
Registration timing:registered_while_recruiting
Last update:2020-05-06, 1399/02/17
Update count:0
Registration date
2020-05-06, 1399/02/17
Registrant information
Name
Hossein Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1427
Email address
hosseinrahimi92@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on anxiety, depression and stress of primary Family Caregivers of Stroke Survivors
Public title
The Effect of Acupressure on anxiety, depression and stress of primary Family Caregivers of Stroke Survivors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of primary caregiver 60-18 year
Ability to read and write
Exclusion criteria:
Lack of physical ability
Lack of desire to continue participating in research
Change the main caregiver
Eliminate the role of the main caregiver
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind clinical trial. Those who evaluate the outcome and analyze the data will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Science
Street address
Ayatollah Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.BUMS.REC.1398.268
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
3
Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
Primary outcomes
1
Description
The level of stress in primary caregivers of patients with stroke.
Timepoint
Before and one day after the end of intervention
Method of measurement
Stress score from the depression, anxiety and stress scale-42
2
Description
The level of anxiety in primary caregivers of patients with stroke.
Timepoint
Before and one day after the end of intervention
Method of measurement
Anxiety score from the depression, anxiety and stress scale-42
3
Description
The level of depression in primary caregivers of patients with stroke.
Timepoint
Before and one day after the end of intervention
Method of measurement
Depression score from the depression, anxiety and stress scale-42
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants in this study will be the primary caregiver of patients with stroke in birjand city. 46 patients will be included in the intervention group. Participants will press the HT7 and GV29 acupressure points. The intervention will be for 15 minutes each morning (5 minutes for each hand and 5 minutes for the third eye) for one month. The DASS 42 questionnaire will be completed one day after the end of the intervention.
Category
Treatment - Other
2
Description
Sham group: 46 patients will be included in the sham group. Participants will press the CV24 and TB5 acupressure points. The intervention will be for 15 minutes each morning (5 minutes for each hand and 5 minutes for the third eye) for one month. The DASS 42 questionnaire will be completed one day after the end of the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Alireza Mahmoudirad
Street address
Ayatollah Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3204 1088
Email
dr_mahmoodi_rad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Hossein Dehghani FIroozabadi
Street address
ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Email
drdehghani@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Fax
Email
Hosseinrahimi92@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Fax
Email
Hosseinrahimi92@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Fax
Email
Hosseinrahimi92@yahoo.com
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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable participants
When the data will become available and for how long
Start of access period 12 months after printing results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to access the data, researchers can request access to the information 12 months after the results are published. Within two weeks, the information will be sent to them.It should be noted that applicants must be faculty members of the Ministry of Health.
From where data/document is obtainable
After verifying the identity of the applicant, the data will be submitted to the researcher within 2 weeks.
What processes are involved for a request to access data/document
Applicants can apply to the Birjand University of Medical Sciences School of Nursing and Midwifery for information.