Determining the effect of acupressure acupuncture points on fatigue and sleep disorders in hemodialysis patients in Ahvaz, 1398.
Design
Clinical trial with intervention and sham-control groups, with single, single-blind, randomized groups with Excel rand function on 40 patients.
Settings and conduct
This study is a single-blind randomized clinical trial (participant unaware of being in an intervention or sham-control group). Location of all teaching hospitals in Ahvaz. Patients are divided into two groups of intervention and sham-control by simple random sampling. One hour after the start of dialysis, three days a week for four weeks will be performed. The sham-control group will receive the intervention at 5 points of the 5-9HX spiral, which are far from the middle points of the ear.
Participants/Inclusion and exclusion criteria
Admission: Patients who have a score of 5 or more according to the Petersburg Questionnaire. Patients undergoing hemodialysis for at least 3 months. Able to communicate. Willingness to participate in the study. 2 to 4 hours per week and each session. Withdrawal: If the patient suffers from complications during dialysis during the intervention and needs immediate medical attention. Surgery, infection and bleeding during the research. Transfer to special wards for any reason. Failure to attend training sessions.
Intervention groups
The intervention group will perform acupressure on 5 points including TF4, AH6a, CO15, AT4 and CO18 at a pressure of 0.3 to 0.4 kg for 8 minutes with a rotating thumb for one hour one hour after the start of dialysis three days a week for four weeks. The sham-controllers receive the intervention at 5 different points of the 5-9HX spiral that are far from the middle points of the ear.
Main outcome variables
Fatigue and sleep disorders in hemodialysis patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201021049102N1
Registration date:2022-01-01, 1400/10/11
Registration timing:prospective
Last update:2022-01-01, 1400/10/11
Update count:0
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Alireza Momeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 7378
Email address
alirezamomeni136@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acupressure in acupuncture on fatigue and sleep disorders in hemodialysis.
Public title
Effect of Auricular acupressure on fatigue and sleep disorders in Hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have a score of 5 or more according to the Petersburg Questionnaire. Perform 2 to 3 hemodialysis sessions per week And each session should be 2 to 4 hours.
Patients undergoing hemodialysis for at least 3 months.
Able to communicate.
Willingness to participate in the study.
Age 18 years and older.
Perform 2 to 3 hemodialysis sessions per week And each session should be 2 to 4 hours.
Exclusion criteria:
If the patient has complications during dialysis during the intervention, he needs immediate medical attention.
Surgery, infection and bleeding at the time of the study.
Transfer to special departments for any reason.
Failure to attend training sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Esfand St., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-10-19, 1399/07/28
Ethics committee reference number
IR.AJUMS.REC.1399.568
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease ESRD
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
sleep disorders.
Timepoint
After 28 days of intervention.
Method of measurement
Petersborg Questionnaire
2
Description
fatigue.
Timepoint
After 28 days of intervention.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received ear acupressure by a nurse (who was evaluated for post-training qualification and approved by an acupuncturist) one hour after starting dialysis three days a week for four weeks on 5 points including TF4, AH6a , CO15, AT4 and CO18 in the form of pressure of 0.3 to 0.4 kg for 8 minutes with a rotating thumb clockwise. These points were selected based on the meridian theory of traditional Chinese medicine (TCM) and on-site clinical practice experience. These points are anatomically connected to the ear branch of the vagus nerve. These points play an important role in sleep by regulating the autonomic nervous system, increasing parasympathetic activity, and decreasing sympathetic activity.
Category
Treatment - Other
2
Description
The sham-control group evaluated ear acupressure by a nurse (who was evaluated for post-training qualification and acupuncture approval) one hour after the start of dialysis three days a week for four weeks on five helical points ( HX 5-9) will receive a pressure of 0.3 to 0.4 kg for 8 minutes with a rotating thumb clockwise. These points are clearly away from the inner ear area and lack evidence to manage insomnia.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeyni Hospital
Full name of responsible person
Alireza Momeni
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University City, Golestan Road.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8331
Email
Alirezamomeni136@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdul Ali Shariati
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University City, Golestan Road.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8331
Email
Alirezamomeni136@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty Grant
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
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza Momeni
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University City, Golestan Road.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8331
Email
Alirezamomeni136@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdul Ali Shariati
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University City, Golestan Road.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8331
Email
Shariati-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza Momeni
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University City, Golestan Road.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3373 8331
Email
Alirezamomeni136@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
Not applicable
Title and more details about the data/document
Part of the data that is related to the main outcome
When the data will become available and for how long
Access one 6 months after printing the results
To whom data/document is available
Only researchers working in academic centers
Under which criteria data/document could be used
Provided request to the responsible executor
From where data/document is obtainable
Executive Officer - Ahvaz Jundishapur School of Nursing
What processes are involved for a request to access data/document
Will be reviewed and answered by the responsible executor