Determining the effect of auriculotherapy on sleep quality, fatigue and severity of restless leg syndrome in hemodialysis patients
Design
A randomized, parallel group, controlled trial
Settings and conduct
This study was designed with the aim of "determining the effect of auriculotherapy on sleep quality, fatigue and severity of restless legs syndrome in patients undergoing hemodialysis" in hospitals affiliated to Kashan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Under continuous hemodialysis treatment for more than six months
Exclusion criteria:
- Not completing the daily note sheet and not doing enough intervention
- Death of the patient during the study
- Unwillingness to continue research- Use of painkillers and painkillers during the study
Intervention groups
60 hemodialysis patients with restless leg syndrome were randomly divided into two control groups and an intervention group. The intervention group is subjected to auriculotherapy in certain points for six weeks.
Main outcome variables
Severity of restless legs syndrome ؛sleep quality؛ fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130721014086N17
Registration date:2023-01-31, 1401/11/11
Registration timing:prospective
Last update:2023-01-31, 1401/11/11
Update count:0
Registration date
2023-01-31, 1401/11/11
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auriculotherapy on sleep quality, fatigue and severity of restless leg syndrome in hemodialysis patients
Public title
The effect of auriculotherapy on sleep quality, fatigue and severity of restless leg syndrome in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60
Suffering from restless leg syndrome with a score of more than 4 from the International Restless Leg Syndrome Questionnaire
scoring 5 or higher from the Pittsburgh Questionnaire
hemoglobin higher than 10 mg/dL
no peripheral neuropathy based on the patient's clinical record
no psychiatric disease based on the patient's clinical record
full consciousness
no known cognitive problems (dementia, Alzheimer's) based on the patient's clinical record
Exclusion criteria:
Disability to read and write
Having vision and hearing problems that interfere with the intervention
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are made in blocks of four and six using Sealed Envelope Ltd software. 2017 available through www.sealedenvelope.com are assigned to two intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants are placed in two intervention and control groups. Stickers with seed are attached in certain areas in the intervention group, and in neutral areas in the control group. The patients do not know about its function.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Medicine and Dentistry- Kashan University of Medical Science
Street address
Kashan, km 3, Qutb Ravandi
City
Kashan
Province
Isfehan
Postal code
88715973474
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.192
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Severity of restless legs syndrome
Timepoint
At the beginning of the study, the sixth week and the tenth week
Method of measurement
International standard restless leg syndrome questionnaire
Secondary outcomes
1
Description
sleep quality
Timepoint
At the beginning of the study, the sixth week and the tenth week
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
fatigue
Timepoint
At the beginning of the study, the sixth week and the tenth week
Method of measurement
Multidimensional fatigue assessment questionnaire
Intervention groups
1
Description
Intervention group: The intervention group will be subjected to auriculotherapy at certain points for six weeks. In the intervention group, pads are attached to the Shenmen, Zero, Thalamus, Subcortex and Sympathetic points, and the patient is told how to apply pressure, which should be done in the form of medium pressure with the thumb and forefinger, every other day and every time 3- 4 times for one to two minutes, it will be explained.
Category
Treatment - Other
2
Description
Control group: In the control group, only the seeds are glued at neutral points and no pressure is applied.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Kashan University of Medical Science
Full name of responsible person
Fatemeh Asgari
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5554 3591
Email
fatimaasgari915@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Golamali Hamidi
Street address
Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5557 8011
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 3591
Email
aghajani1362@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 3591
Email
aghajani1362@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
کاشان، کیلومتر 3 قطب
Phone
+98 31 5554 3591
Email
aghajani_m@kaums.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