1. Home
  2. Approved trials
  3. » فارسی

The effect of acupressure on the intestinal function of patients with acute myocardial infarction under primary angioplasty

Protocol summary

Study aim
The determine of effects of acupressure on intestinal function of patients with acute myocardial infarction
Design
Three-group randomized controlled clinical trial
Settings and conduct
The SJ6 - LI4 - ST25- SP6 points of both members are determined symmetrically by the researcher's fingers. Acupressure will be performed twice a day (10am and 6pm) from the beginning of the day for three days.
Participants/Inclusion and exclusion criteria
Acute myocardial infarction, which is confirmed by a laboratory positive blood troponin level and confirmed by a physician. No more than 12 hours of myocardial infarction No chronic constipation based on RomeIV criteria  Written and verbal consent to participate in the study  Age above 18  Ability to communicate verbally  No known mental illness under treatment Absence of ulcers, organ failure, tenderness and fractures in acupressure points  Lack of simultaneous participation in other intervention studies  no thyroid disease, incurable, neuromuscular, congenital gastrointestinal malformations and renal failure, no gastrointestinal disorders (gastric ulcer, chronic constipation history, fisher, hemorrhoids, prolapse of the rectum, obstruction of the rectum, obstruction) , Biography and physical examination by a physician No dependence or addiction to any drugs
Intervention groups
The SJ6 - LI4 - ST25- SP6 points of both members are determined symmetrically by the researcher's fingers. Acupressure will be performed twice daily (10am and 6pm) from the beginning of the day for three days. Control group: These patients are given nutritional and routine heart disease training. . There is no intervention in this group. Sham group: The sham group offers routine nursing nutrition and care training
Main outcome variables
Improve intestinal function and prevent constipation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110906007494N31
Registration date: 2020-03-20, 1399/01/01
Registration timing: registered_while_recruiting

Last update: 2020-03-20, 1399/01/01
Update count: 0
Registration date
2020-03-20, 1399/01/01
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
2019-12-22, 1398/10/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on the intestinal function of patients with acute myocardial infarction under primary angioplasty
Public title
acupressure in cardiac patient
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Acute myocardial infarction, which is confirmed by a laboratory positive blood troponin level and confirmed by a physician. Written and verbal consent to participate in the study Age over 18 Ability to communicate verbally
Exclusion criteria:
No more than 12 hours of myocardial infarction No chronic constipation based on RomeIV criteria Lack of known mental illnesses under treatment Absence of ulcers, organ failure, tenderness and fractures in acupressure points Lack of simultaneous participation in other intervention studies no thyroid disease, incurable, neuromuscular, congenital gastrointestinal malformations and renal failure, no gastrointestinal disorders (gastric ulcer, chronic constipation history, fisher, hemorrhoids, prolapse of the rectum, obstruction of the rectum, obstruction) , Biography and physical examination by a physician No dependence or addiction to any drug
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
۴۸۹/۵۰۰۰ Eligible patients were randomly assigned to three groups of 30 acupressure, sham, and control groups using random numbers provided with computer software and Randomization Permuted Block. 15 to 6 blocks so that there are 2 people in each block. Therefore, 90 envelopes are designed and embedded inside based on information obtained from the computer program of letters A of acupressure group, B of sham group and C of control group. Based on the patient's admission date, the priority of opening the envelope is executed on the order of the number.
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
2020-01-04, 1398/10/14
Ethics committee reference number
IR.MAZUMS.REC.1398.1256

Health conditions studied

1

Description of health condition studied
myocardial infarction
ICD-10 code
I21.3
ICD-10 code description
ST elevation (STEMI) myocardial infarction of unspecified site

Primary outcomes

1

Description
intestinal function
Timepoint
Before and the first day to 4th day of intervention
Method of measurement
Bristool scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1 : The SJ6 - LI4 - ST25- SP6 points of both members are determined symmetrically by the researcher's fingers. Acupressure will be performed twice daily (10 am and 6 pm) from the beginning of the day for three days. Point ST25 (Tianshu) is located two fingers away from the navel . The LI4 (Hegu) point lies at the depth of the muscle bundle, resulting from the thumb and forefinger . The SJ6 (Zhigou) dot is located four inches above the transverse line of the wrist between Radius and Ulna . The SP6 (sanyinjiao) point is four fingers above the medial ankle behind the posterior edge of the tibia. Apply acupressure on each spot symmetrically for two minutes. Apply a minute with your thumb pressed vertically, then rest for 5 seconds and then rotate for one minute. A total of 9 minutes of intervention will be administered to the patient each time. Nutrition training and routine nursing care are also provided.
Category
Prevention

2

Description
Intervention group2: The sham group offers routine nursing education and care, and the procedure will be exactly the same as the intervention group, except that pressure is close to the acupressure points according to accredited acupressure specialists in the field, which is about half that. No special timber is applied. The order of the pressure, the type of pressure, the position of the patient, the time and the amount of pressure in the test and sham groups will be the same. The location of the pressure points is similar to that of the intervention group except that they are 1.5 cm apart. It should be noted that in both groups, the pressure procedure will be taught by one person (the researcher). Intestinal function and checklists will then be completed before the intervention and in the first to fourth days.
Category
Placebo

3

Description
Control group: After introducing and expressing the aims of the study and obtaining written informed consent and patient's consent to participate in the study, these patients receive nutritional and routine heart disease training. The demographic and medical information questionnaire, symptom checklist, Rome scale and Bristol are completed. There is no intervention in this group. Intestinal function indicators will be completed before the intervention and in the first to fourth days.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Mahsa Kamali
Street address
Imam Sq, Joybar 3way, valiye asr highway, Mazandaran University of Medical Sciences, Sari, Iran
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3336 1985
Email
kamali2n@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Mazandaran University of Medical Sciences ,valiye asr highway, Joybar 3way ,Imam Sq,Sari, Mazandaran,Iran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3379 5508
Email
kamali2n@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research 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

2

Sponsor
Name of organization / entity
University researches Assistance
Full name of responsible person
Dr Masoomeh Bagheri Nesami
Street address
Traditional and Comlementary Medicine Research Center, Next to the Tooba Medical Complex, Khazar boulevard, Sari,Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Email
tcmrc.mazums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University researches Assistance
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
Mazandaran 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
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
Mazandaran 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
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
Mazandaran 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
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
No decision yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Loading...