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Comparison of acupressure and eucalyptus inhalation on headache intensity in hemodialysis patients

Protocol summary

Study aim
Comparison of acupressure and eucalyptus inhalation on headache intensity in hemodialysis patients
Design
A randomized clinical trial with 33 samples with 3 groups; 2 test groups and a control group ​
Settings and conduct
For the first test group, acupressure is performed at HeGu, Yin Tang, Taiyang, and GB20 points. The duration of the intervention for each patient is 3 sessions in three visits consecutively. At the beginning of dialysis (first 20 minutes), each point for 1 minute, as a pressure for 8 seconds, followed by 2 seconds of rest. For the second test group, aromatherapy is performed with aromatic eucalyptus extract, 1 ml of which is placed on a 2*4 gas and inhaled for 5 minutes from a distance of 30 cm at the beginning of dialysis. Location: At Salam dialysis center in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: -Patients who complain of headache - Absence of swelling and numbness in HeGu, Taiyang, Yin Tang, GB21points - Not using acupressure simultaneously with this study - Absence of any wound, scratch, infection and deformity in HeGu, Taiyang, Yin Tang, GB21points. - Absence of olfactory disorder -Having informed consent to participate in the study - Not having advanced neuropathy -Having at least 1 pain score in the head area based on the pain measurement scale Exclusion criteria: -The patient's unwillingness to enter the study -having a history of using acupressure and eucalyptus inhalation or any aromatherapy to treat headaches in the past​ -frequent and chronic use of narcotic drugs -drug addiction
Intervention groups
The first test group of acupressure, The second test group of aromatherapy with eucalyptus inhalation,control group
Main outcome variables
Reduction of headache at the lowest cost in hemodialysis patients ​

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240205060907N1
Registration date: 2024-04-08, 1403/01/20
Registration timing: prospective

Last update: 2024-04-08, 1403/01/20
Update count: 0
Registration date
2024-04-08, 1403/01/20
Registrant information
Name
Mohammad mahdi Narimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3364 6233
Email address
narimani.mahdii77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of acupressure and eucalyptus inhalation on headache intensity in hemodialysis patients
Public title
Effect of acupressure and eucalyptus inhalation on headache in hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who complain of headache according to their own statement and by entering in the file Absence of swelling and numbness in HeGu, Taiyang, Yin Tang, GB21 (Gall Bladder) points in test group one. Not using acupressure for any purpose in all three groups at the same time as this study Absence of any wound, scratch, infection and deformity in HeGu, Taiyang, Yin Tang, GB21 (Gall Bladder) points in test group one. Absence of olfactory disorder in the second test group Having informed consent to participate in the study No advanced neuropathy for all three groups Having a minimum score of 1 pain in the head area based on the pain measurement scale​
Exclusion criteria:
Having a history of using Acupressure and Eucalyptus inhalation or any Aromatherapy to treat Headaches in the past​ Frequent and Chronic use of Narcotic Drugs Drug Addiction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple random allocation using random number table method is used. For this purpose, people are numbered and registered on paper from 1 to 33 in the order of their entry into the study. The direction of reading the numbers is chosen by the researcher from left to right. Then the researcher randomly places his hand on one of the numbers with his eyes closed and moves in a predetermined direction; The first 11 numbers to the acupressure group, 11 Next number to the Eucalyptus inhalation group, And the rest are in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees of Islamic Azad university-Isfahan(Khorasga) branch
Street address
Isfahan Islamic Azad University, Isfahan Khorasgan Branch, University Blvd, Arghwaniyeh, East Gey Street , Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.417

Health conditions studied

1

Description of health condition studied
Headache in hemodialysis patients
ICD-10 code
Z49
ICD-10 code description
Encounter for care involving renal dialysis

Primary outcomes

1

Description
Headache score in numerical rating scale
Timepoint
At the beginning of the study (before the start of the study), immediately after the intervention
Method of measurement
Numeric Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Acupressure is performed for the first test group. In this study, acupressure applied pressure on the HeGu points between the first and second bones of the palm, Yin Tang between the eyebrows, Taiyang on the external corners of the eyes, and GB20 (Gallbladder20) on the vertebrae. The first is neck. The amount of pressure applied should be such that the person feels a little heat and pain in the pressured area. The duration of the intervention for each patient is 3 sessions in three consecutive visits. At the beginning of dialysis (the first 20 minutes), each point is pressed for 1 minute, in the form of pressure for 8 seconds, followed by 2 seconds of rest, a total of 4 minutes for each patient in each session.
Category
Other

2

Description
Intervention group: Aromatherapy is performed for the second test group. This group is treated with aromatic eucalyptus extract, 1 ml of which is placed on a 2/4 gas and inhaled for 5 minutes from a distance of 30 cm at the beginning of dialysis (first 20 minutes).
Category
Other

3

Description
Control group: No action is taken in the control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Salam dialysis center
Full name of responsible person
Mohammad Mahdi, Sabokdast
Street address
Khavaran Central Hospital- corner of Hashemi Street- Kashi Street- Khavaran- Tehran
City
Tehran
Province
Tehran
Postal code
1799713493
Phone
+98 21 3343 2482
Email
khavaran@salamdc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mahdi, Tehranchi
Street address
Islamic Azad University (Khorasgan), Isfahan branch, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammad Mahdi, Narimani
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
4th floor, No. 117, 31 St., Afsariyeh, Tehran
City
Tehran
Province
Tehran
Postal code
1784899314
Phone
+98 21 3364 6233
Email
narimani.mahdii77@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam, Radmehr
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan Islamic Azad University, Isfahan Khorasgan Branch, University Blvd, Arghwaniyeh, East Gey Street , Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
35002117
Email
maryam.radmehr3132@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Mahdi, Narimani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
4th floor, number 117, 31 St., Afsarieh, Tehran
City
Tehran
Province
Tehran
Postal code
1784899314
Phone
+98 21 3364 6233
Email
narimani.mahdii77@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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