The effect of self-acupressure education on blood glucose index and anxiety in patients with pre-diabetes
Design
Three-group randomized controlled clinical trial
Settings and conduct
The ST36 - LIV 3 - K 3 - SP 6 points of both feet are by the fingers of the patient in the acupuncture group. For reduce anxiety, massage the p6 point for 5 minutes daily. Pressure duration of 12 weeks and 5 minutes for each point and each day of the week with 10 seconds of massage and 2 seconds of rest, totaling 21 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Having definitive diagnosis of pre-diabetes, Written and oral consent, Over18 years of age , Ability to communicate
Exclusion criteria:absence of clear and clinically approved neuropathy - No known psychiatric illness under treatment - Absence of wounds, organ failure, allergies And fractures in acupressure points - failure to participate in other interventional studies - no pregnancy and lactation (there is a risk of miscarriage) - no other infectious diseases
Intervention groups
Acupressure with metformine group:ST36 - LIV 3 - K 3 - SP 6 points with both fingers determined by the patient's own finger.Pressure duration of 5 minutes for each point and daily for 5 weeks.10 minutes of massage and 2 seconds of rest for a total of 21 minutes.For reduce anxiety, massage the p6 point for 5 minutes daily. Blood glucose and hemoglobin glycolysis and anxiety are measured and recorded in all 2 groups before the start of the intervention and after the end of the 12 weeks.
Sham with metformine group:Routine training will be given for diabetes and the procedure will be exactly the same as for the test group, except that pressure is not applied to acupuncture points according to acupuncture specialists at a specific meridian within 1.5 cm.
Main outcome variables
Glycemic and HA1C and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N36
Registration date:2021-01-31, 1399/11/12
Registration timing:prospective
Last update:2021-01-31, 1399/11/12
Update count:0
Registration date
2021-01-31, 1399/11/12
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-acupressure education on blood glucose index and anxiety in patients with pre-diabetes
Public title
Acupressure in patients with pre-diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a definitive diagnosis of pre-diabetes - Having written and verbal consent to participate in the study - Over 18 years of age - Ability to communicate, absence of clear and clinically confirmed neuropathy - Not known mental illness under treatment - Absence of ulcer, Defects, allergies, and fractures in acupuncture targeted areas - Failure to participate in other interventional studies - Pregnancy and lactation (risk of miscarriage) - No other serious illnesses - No liver disease, kidney disease And heart failure
Exclusion criteria:
Desire to Exclude from the Study - Improper Massage - Illness and Patient Death During Study - Hospitalization and Change of Medication - Presence of Clear and Confirmed Neuropathy During Study - No adherence of Metformin Pills
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients were randomly assigned to two groups of 44 acupressure with metformin, sham with metformin , groups using random numbers provided with computer software and Randomization Permuted Block. 22 blocks with size 4 so that there are 2 people in each block. Therefore, 88 envelopes are designed and embedded inside based on information obtained from the computer program of letters A of acupressure group, B of sham group. The priority of opening the envelope is executed on the order of the number based on the patient's admission date.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
SARI
Province
Mazandaran
Postal code
4816715793
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.MAZUMS.REC.1398.1393
Health conditions studied
1
Description of health condition studied
Pre-diabetes and Anxiety
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Blood sugar indices
Timepoint
Before and 12 weeks after intervention
Method of measurement
Anxiety questionnaire and blood test
Secondary outcomes
empty
Intervention groups
1
Description
Acupressure with metformine group: After introducing and stating the aims of the study and obtaining written informed consent and patient cooperation to complete the study and after filling out the questionnaire, the researcher will learn how to pressure the points of interest. In this study a demographic and medical information questionnaire and a blood glucose index checklist were recorded. Then the subjects are positioned backwards, with the head 30 degrees above the shoulders, and the thumbs are positioned bilaterally on the SP6 point (4 fingers above the medial ankle). Massage in a clockwise and counterclockwise manner. For reduce anxiety, massage the p6 point for 5 minutes daily. Then, to ensure patient learning, the patient is massaged several times to allow the researcher to learn from the patient, and the rest is massaged. Pressure duration of 5 minutes for each point and every day of the week (5 minutes on both feet) with 10 seconds of massage and 2 seconds of rest, totaling 21 minutes (1 minute of 2 seconds rest between Massage is the point), performed for 12 consecutive weeks (18). Blood glucose and hemoglobin glycolysis and anxiety indices were measured and recorded in a laboratory before and after the intervention for 12 weeks.
Category
Prevention
2
Description
Intervention group2: In the sham with metformine group, the procedure will be exactly the same as that of the test group, except that pressure is applied at points close to the acupressure points according to accredited acupuncture specialists in the field, who do not place this on the meridian. The order of pressure, mode of pressure, position of the patient, time, and amount of pressure in the test and sham groups were the same. It should be noted that in both groups, the pressure procedure will be taught by one person (the researcher). Blood glucose and glycated hemoglobin are then measured before and 12 weeks after baseline.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafavian Diabetes Clinic of Imam Khomeini Hospital in Sari
Full name of responsible person
sahar haghighat
Street address
Mazandaran University of Medical Sciencesvaliye asr highway,Joybar 3way,Imam ،Sari. Iran.
City
SARI
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3336 7555
Email
Haghighat_sahar85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sari University of Medical Sciences
Full name of responsible person
University researches Assistance-Traditional Medicine Research Center
Street address
Mazandaran University of Medical Sciences,valiye asr highway, Joybar 3way,, Imam Sq.Sari.Iran.
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3337 5555
Email
Haghighat_sahar85@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Sari University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bagheri Nasami
Position
PhD of nursing education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences.Sari.Iran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3379 5508
Email
Mbagheri@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sari University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bagheri Nasami
Position
Ph.D. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences.Sari. Iran.
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3379 5508
Email
Mbagheri@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sari University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bagheri Nasami
Position
Ph.D. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences. Sari. Iran.
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3379 5508
Email
Mbagheri@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The research team has not yet made a decision on this issue.