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The effect of acupressure on chest pain, anxiety and vital signs in the elderly with acute coronary syndrome

Protocol summary

Study aim
Determining the effect of acupressure on chest pain, anxiety and vital signs in elderly patients with acute coronary syndrome
Design
The clinical trial is a randomized double-blind study. The study population will be all elderly people with acute coronary syndrome who refer to the emergency room of Madani Hospital in Khorramabad city. Phase 2 on 110 patients was used for randomization using the rand function of Excel software.
Settings and conduct
When the patient goes to the emergency room and after the triage and visit by the emergency doctor and the diagnosis of acute coronary syndrome, the level of anxiety, pain and vital signs will be measured immediately before the intervention. In the intervention group, the Shen Men (HT7), Shen Men Gusi and Yin Tong points (third eye) will be gently pressed for 5 minutes, and after the intervention, 10, 20 and 30 minutes later, the level of anxiety, pain and vital signs will be measured. will be taken In the control group, it will be done in places other than acupressure points.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 60 years and older, U/A and NSTEMI patients, pain score 3 to 8, not having diabetes and previous heart attack and exclusion criteria: smoking, alcohol and drug addiction, having mental illness, having anatomical problems in Location of acupressure points
Intervention groups
patients will be randomly divided into intervention and control groups. In the intervention group, acupressure will be performed in three points, and in the control group, the intervention will be performed with the same technique and duration as the intervention group, in points near the acupressure points.
Main outcome variables
Pain, anxiety, systolic and diastolic blood pressure, heart rate and breathing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240723062519N2
Registration date: 2024-11-12, 1403/08/22
Registration timing: registered_while_recruiting

Last update: 2024-11-12, 1403/08/22
Update count: 0
Registration date
2024-11-12, 1403/08/22
Registrant information
Name
Reza Hosseinabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0140
Email address
reza_hosseinabadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on chest pain, anxiety and vital signs in the elderly with acute coronary syndrome
Public title
The effect of acupressure on acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years and older Willingness to participate in the study Both genders Definitive diagnosis of heart pain by an emergency physician Patient alertness Pain score of 3 and above and 8 and below 8 Patients with unstable angina and without ascending St Not having any wounds on the body Not having a history of heart attack No having a history of diabete Failure of the patient to go to the emergency room by the 115 medical emergency team
Exclusion criteria:
Acute heart attack The patient's loss of consciousness upon entering the emergency room or during the implementation of the intervention Death or unwillingness to continue cooperation for any reason Having a known mental illness such as anxiety Addiction to smoking, alcohol and drugs Having an anatomical problem at the location of acupressure points Having a history of previous heart attack
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to balance the number of samples allocated to each of the study groups (intervention and placebo groups), block randomization method is used. For this purpose, random blocks of 4 are used to assign patients with acute coronary syndrome to two groups. 6 different combinations of blocks of 4 (AABB- ABAB- ABBA- BBAA- BABA- BAAB) are created and randomly selected using the Blockrand package of R software, and the random sequence is a sequence of letters. A and B will be formed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants will not be informed of being placed in the intervention or placebo group, and the person evaluating the questionnaires will not be aware of which participant is in which group.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of lorestan University of Medical Sciences
Street address
Lorestan, Kamalvand, Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2024-01-11, 1402/10/21
Ethics committee reference number
IR.LUMS.REC.1402.321

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Before the intervention, immediately after the intervention, 10 minutes after the intervention, 20 minutes after the intervention, 30 minutes after the intervention
Method of measurement
Numerical pain intensity measurement scale

2

Description
Anxiety
Timepoint
Before the intervention, immediately after the intervention, 10 minutes after the intervention, 20 minutes after the intervention, 30 minutes after the intervention
Method of measurement
DASS-21 stress, anxiety and depression questionnaire, anxiety subscale

3

Description
Vital signs
Timepoint
Before the intervention, immediately after the intervention, 10 minutes after the intervention, 20 minutes after the intervention, 30 minutes after the intervention
Method of measurement
Vital signs chart sheet using bedside monitoring in the emergency department

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Gentle pressure for 5 minutes will be applied to the three pressure points of Shen Men, Yin Tong, and HT7 point for the patients.
Category
N/A

2

Description
Control group: In the placebo group, acupressure with the same technique and duration as the intervention group and in places near the acupressure points of the intervention group, where there are no acupressure points according to the expert's opinion, will be performed for the patients.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Hospital, Khorramabad
Full name of responsible person
Arash Amin
Street address
Khairabad
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Fax
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Web page address
https://hmadani.lums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Bahram Delfan
Street address
Khorram Abad, Anoushirvan Square
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Fax
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Web page address
https://lums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Reza Hossein Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5 km from Khorramabad - Borujard road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Reza_hosseinabadi@yahoo.com
Web page address
https://lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mohammad Fatahi Moghadam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tadaman St., Koche Bastan 2, No. 7
City
Khorramabad
Province
Lorestan
Postal code
6814737203
Phone
+98 66 3341 3200
Email
muhammadfatahimoghadam2178@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mohammad Fatahi Moghadam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tadaman St., Koche Bastan 2, No. 7
City
Khorramabad
Province
Lorestan
Postal code
6814737203
Phone
+98 66 3341 3200
Email
muhammadfatahimoghadam2178@gmail.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
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
In the form of a student thesis file, all information will be available to the Faculty of Nursing and Midwifery of Lorestan University of Medical Sciences and will be available to the public.
When the data will become available and for how long
Immediately after the publication of the thesis
To whom data/document is available
All people who may need the contents of this thesis.
Under which criteria data/document could be used
It does not have any special conditions and will be accessible in the library of Khorramabad Nursing and Midwifery College.
From where data/document is obtainable
Khorramabad Nursing and Midwifery College
What processes are involved for a request to access data/document
Refer to the library of Khorramabad College of Nursing and Midwifery
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