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Comparison of the effect of acupressure from the 7th lung (Lie que7(LU7)) to the 10th lung (Lie que10 (LU10)) and the 13th bladder point (BL13) on shortness of breath and fatigue in patients with asthma and chronic obstructive pulmonary disease (COPD) Chronic obstructive pulmonary disease

Protocol summary

Study aim
Comparing the effect of acupressure on lung points 7-10 and bladder point 13 on shortness of breath and fatigue in patients with asthma and COPD.
Design
In this study,150patients with asthma and COPD and who met the conditions for entering the study,who visited Valiasr Hospital in Birjand,were selected.The participants were randomly assigned to two groups of intervention and control and assigned to each participant a given code.
Settings and conduct
By conducting a pre-test and completing demographic information questionnaires in patients referred to Valiasr Birjand Hospital, in one group massage points lu 7 to lu 10, in another group massage points bl 13, and in both groups massage 3 rounds; morning, afternoon, each round for 5 minutes for each hand or shoulder. The fatigue and shortness of breath questionnaire will be completed again at the end of the intervention. The study is a three-way blind study, and the participants, data analysts, and outcome evaluators have not been given and will not be informed about the process of blinding.
Participants/Inclusion and exclusion criteria
Entry conditions:not suffering from heart disease,musculoskeletal or neurological disorders;not suffering from mental disorders,neuropathy disorders,absence of inflammation,bite or fracture at the massage point. Conditions for not entering:withdrawing from the study at any stage;Any incident that prevents the continuation of the intervention.
Intervention groups
Intervention group:performing the pre-test,in one group,lu7 to lu10 point massage and in the other group,bl13 point massage will be performed, and in both groups, the massage will be done three times:morning,noon and night, and each time for each hand or shoulder will be 5 minutes.
Main outcome variables
Examination of patients' fatigue and shortness of breath before and after the intervention in the intervention and control groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171013036747N3
Registration date: 2022-09-03, 1401/06/12
Registration timing: prospective

Last update: 2022-09-03, 1401/06/12
Update count: 0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Rasool Solaimani Moghadam
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
mahdi.hosseini@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-20, 1401/06/29
Expected recruitment end date
2023-07-20, 1402/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acupressure from the 7th lung (Lie que7(LU7)) to the 10th lung (Lie que10 (LU10)) and the 13th bladder point (BL13) on shortness of breath and fatigue in patients with asthma and chronic obstructive pulmonary disease (COPD) Chronic obstructive pulmonary disease
Public title
Comparison of the effect of acupressure on shortness of breath and fatigue in patients with asthma and ( Chronic obstructive pulmonary disease(COPD))
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least reading and writing skills Not having cognitive impairment, hearing loss or hearing loss Would like to participate in this research. Absence of anemia, heart disease, skeletal and muscular or neurological disorders Not suffering from diseases such as Alzheimer's, dementia, peripheral vascular diseases, neuropathy caused by diabetes Absence of inflammation and bite or fracture at the massage point
Exclusion criteria:
Cancellation of the study at any stage Any incident that prevents further intervention. Patient death
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 150
More than 1 sample in each individual
Number of samples in each individual: 1
75 people are examined in each group.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, data analysts, and outcome evaluators were not informed about the method of blinding the participants.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghafari Street, Birjand
City
Birjand
Province
South Khorasan
Postal code
971785377
Approval date
2022-06-19, 1401/03/29
Ethics committee reference number
IR.BUMS.REC.1401.117

Health conditions studied

1

Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
Asthma

2

Description of health condition studied
COPD
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
tiredness
Timepoint
Before the intervention and three days after the intervention
Method of measurement
FSS Standard Fatigue Severity Questionnaire

2

Description
Shortness of breath
Timepoint
Before the intervention and three days after the intervention
Method of measurement
Shortness of breath scale (OCD)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: LU7 to LU10 point massage, for three days and three times: morning, noon, night and each time 5 minutes.
Category
Rehabilitation

2

Description
Intervention group: BL13 point massage, for three days and three times: morning, noon, night and 5 minutes each time
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Waliasr Hospital
Full name of responsible person
Rasool Solaimani Moghaddam
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
971785377
Phone
+98 56 3162 2001
Email
Valiasr@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Miri
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
971785377
Phone
+98 56 3238 1200
Email
Research@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
90
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
Rasool Solaimani Moghaddam
Position
Nursing non-faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
971785377
Phone
+98 56 3238 1200
Email
Rasool.solaimani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Rasool Solaimani Moghadam
Position
Nursing non-faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
971785377
Phone
+98 56 3238 1200
Email
rasool.solaimani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Rasool Solaimani Moghadam
Position
Nursing non-faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
971785377
Phone
+98 56 3238 1200
Email
rasool.solaimani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
10 months after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Just statistical tests
From where data/document is obtainable
To receive the data, they can only send their application to the email address of the person responsible for the study E-mail:rasool.solaimani@yahoo.com
What processes are involved for a request to access data/document
After reviewing the ethics code of the respective research committee and the approval date and the university identification certificate of the applicant
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