Determining the effect of acupressure on anxiety and hemodynamic parameters in the elderly with hypertension
Design
clinical trial, double-blind, randomized, total 94 people
Settings and conduct
Point P6, located on the inside of the forearm and in the cavity between the forearm bones and the size of three finger widths above the wrist crease. In the experimental group, pressure intervention on point p6 will be performed for ten minutes in both hands. In the control group, pressure was applied on the thumb. Participants will not be explained the difference between pressure in the control group and in the experimental group, and only the pressure on the P6 point or thumb flexor will be stated by the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Do not use sedatives and anti-anxiety drugs, age 60-79, only patients taking Losartan 25 mg every 12 hours.
Criteria for not including the sample include: the occurrence of any problems or instability in vital signs during the study.
Intervention groups
In the experimental group, the intervention, ie pressure on the p6 point, will be performed for 10 minutes in both hands. In the control group, pressure will be applied to the thumb as much as the test group.
Main outcome variables
In this study, anxiety, blood pressure and pulse of the elderly with hypertension were measured before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210807052097N1
Registration date:2021-08-11, 1400/05/20
Registration timing:registered_while_recruiting
Last update:2021-08-11, 1400/05/20
Update count:0
Registration date
2021-08-11, 1400/05/20
Registrant information
Name
Sara sadat Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4324 7326
Email address
hosseinisara345@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on anxiety and hemodynamic indices of elderly with hypertension: Randomized Clinical Trial
Public title
The effect of acupressure on anxiety and hemodynamic indices of elderly with hypertension
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Having literacy
Being in the age range of 60-79
No drug addiction
No anatomical and skin problems at point P6
Anxiety levels above 40 (according to Spielberger)
No history of using acupressure
Absence of diagnosed mental illness
At least one year has passed since their doctor diagnosed high blood pressure
No other underlying disease such as diabetes
The type of medication used to treat high blood pressure (To prevent the possible effect of the medication taken by patients, only patients taking Losartan 25 mg every 12 hours are included in the study)
Exclusion criteria:
Reluctance to participate in further study
Occurrence of any problems or instability in vital signs during the study
Age
From 60 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling by available method and then for randomization of sealed envelopes containing one of the numbers 1 and 2 (94 in total: 47 from each number) will be used which is selected by the samples and according to the contents of the envelope It was determined in which group it would be placed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The control group receives acupressure at an ineffective point. The control group will not know if the point is ineffective.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Neishabour University of Medical Sciences
Street address
Neishabour, Baghcheban town, end of Moqawmat Boulevard, Medical Sciences Campus
City
neyshabour
Province
Razavi Khorasan
Postal code
93186-14139
Approval date
2020-09-23, 1399/07/02
Ethics committee reference number
IR.NUMS.REC.1400.005
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
Before and after the intervention
Method of measurement
Spielberger Anxiety Inventory
2
Description
Systolic and diastolic blood pressure
Timepoint
Before, immediately and 30 minutes after the intervention
Method of measurement
Monitoring device made by the seekers of the path of happiness
3
Description
Pulse count
Timepoint
Before, immediately and 30 minutes after the intervention
Method of measurement
Monitoring device made by the seekers of the path of happiness
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, the intervention, ie pressure on the p6 point, will be performed for ten minutes in both hands, first the right hand and then the left hand. The accuracy of the point is confirmed when the patient feels warm, heavy, swollen, or numb at that point.
Category
Treatment - Other
2
Description
Control group: In the control group, pressure was applied to the thumb as much as the experimental group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neishabour city health centers
Full name of responsible person
sara sadat hosseini
Street address
Neishabour, Baghcheban town, end of Moqawmat Boulevard, Medical Sciences Campus
City
Neishabour
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4324 7326
Email
hosseinisara345@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Neishabour University of Medical Sciences
Street address
Neishabour, Baghcheban town, end of Moqawmat Boulevard, Medical Sciences Campus
City
neyshabour
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4330 6201
Email
edu@nums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Sara Sadat Hosseini
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neishabour, Baghcheban town, end of Moqawmat Boulevard, Medical Sciences Campus
City
neyshabour
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4330 6201
Email
hosseinisara345@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
sara sadat hosseini
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neishabour, Baghcheban town, end of Moqawmat Boulevard, Medical Sciences Campus
City
neyshabour
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4330 6201
Email
hosseinisara345@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
sara sadat hosseini
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neishabour, Baghcheban town, end of Moqawmat Boulevard, Medical Sciences Campus
City
neyshabour
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4324 7326
Email
hosseinisara345@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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All academic, scientific, industrial
Under which criteria data/document could be used
Any analysis on the data is allowed. However, printing the article based on information is prohibited.
From where data/document is obtainable
Responsible author of the article
What processes are involved for a request to access data/document
Upon request, it will be sent via personal email (Sara Sadat Hosseini) after a maximum of 1 week.
hosseinisara345@yahoo.com
Comments
After requesting the data, the data will be sent by email to the responsible author after a maximum period of one week.