Determining the effect of acupressure on sleep quality and fatigue in individuals with diabetic neuropathy
Design
This clinical trial is randomized, double-blind, and controlled, involving 66 patients. Participants are randomly assigned to the intervention and control groups using a coin toss method.
Settings and conduct
The study is conducted at Khomein health centers with diabetic neuropathy patients. Patients are randomly assigned to intervention (home-based acupressure) and control groups. The study is double-blind, and neither the participants nor the statistical analyst are aware of the group assignments.
Participants/Inclusion and exclusion criteria
Main Inclusion Criteria
Age between 40 and 79 years، Confirmed type 2 diabetes، HbA1c below 7% (up to 8% for elderly or high hypoglycemia risk patients)، Confirmed peripheral neuropathy.
Main Exclusion Criteria
Unrelated neurological disorders; foot wounds; pregnancy or breastfeeding; use of drugs affecting sleep or fatigue; lower limb injury or surgery; stimulant or alcohol use; recent similar interventions.
Intervention groups
In the intervention group, acupressure is applied at home for four weeks, three sessions per week, each lasting 26 minutes, focusing on specific points chosen to reduce fatigue and improve sleep quality. Pressure is applied with the thumb at a defined speed and duration. The control group receives a similar acupressure intervention but on sham points to control for placebo effects. All procedures are conducted under trained supervision with standardized conditions maintained during sessions.
Main outcome variables
Sleep quality؛ fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250607066101N2
Registration date:2025-10-20, 1404/07/28
Registration timing:prospective
Last update:2025-10-20, 1404/07/28
Update count:0
Registration date
2025-10-20, 1404/07/28
Registrant information
Name
Marzieh Mousivand
Name of organization / entity
The University Of Khomein
Country
Iran (Islamic Republic of)
Phone
+98 66 4260 1453
Email address
marzie.mosivand@khomeinums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-22, 1404/07/30
Expected recruitment end date
2026-09-21, 1405/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of Acupressure on Sleep Quality and Fatigue in Patients with Diabetic Neuropathy
Public title
Effect of acupressure on sleep and fatigue in diabetic neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must be aged between 40 and 79 years.
Participants must have type 2 diabetes.
Diabetes diagnosis must be confirmed and registered at the health center.
HbA1c level in adults must be below 7%.
In elderly patients or those with a high risk of hypoglycemia, HbA1c should be below 8% to maintain safety.
Peripheral neuropathy must be confirmed by diagnostic tests.
Pittsburgh Sleep Quality Index score indicating poor sleep must be greater than 6.
Total fatigue questionnaire score must be equal to or greater than 60.
Physical fatigue score must be equal to or greater than 9.
Mental fatigue score must be equal to or greater than 9.
Reduced motivation score must be equal to or greater than 9.
Reduced activity score must be equal to or greater than 10.
General fatigue score must be equal to or greater than 11.
Participant must be able to complete the questionnaire.
Participant must provide informed consent to participate in the study.
Exclusion criteria:
Neurological disorders unrelated to the study (e.g., Multiple Sclerosis, spinal cord injury).
Presence of any active foot wound or skin lesion that interferes with the intervention.
Current use of medications that affect sleep or fatigue.
History of injury or surgery in the lower limbs.
History of stimulant drug use.
Pregnancy or lactation.
History of alcohol consumption.
Participation in similar interventions (e.g., massage therapy, physiotherapy) during the past three months.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to the intervention and control groups using a coin toss method."
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, for blinding purposes, sham points will be used for the control group. These points are located near the main points used in the intervention group but do not have therapeutic effects. This approach is intended to maintain participant blinding and allow for a more accurate assessment of the intervention's effects.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Khomein University of Medical Sciences Ethics Committee
Street address
Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881743364
Approval date
2025-09-20, 1404/06/29
Ethics committee reference number
IR.KHOMEIN.REC.1404.026
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
E08.21
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic nephropathy
Primary outcomes
1
Description
Sleep Quality
Timepoint
The primary outcome measurement time points in this study include assessing sleep quality at baseline (before intervention) and at the end of weeks 1, 2, 3, and 4 of the intervention.
Method of measurement
In this study, sleep quality is measured using the Pittsburgh Sleep Quality Index questionnaire. This questionnaire consists of 19 items assessing sleep quality across seven dimensions, including subjective sleep quality, sleep duration, and sleep disturbances.
Secondary outcomes
1
Description
Fatigue
Timepoint
It is at the beginning (before the intervention starts) and at the end of the first, second, third, and fourth weeks of the intervention.
Method of measurement
Fatigue is assessed using the Multidimensional Fatigue Inventory questionnaire.
Intervention groups
1
Description
Intervention group: The intervention consists of home-based acupressure for diabetic neuropathy patients. It involves pressing specific foot points with the thumb at a rate of two rotations per second for 26 minutes, three times a week, over four weeks. The selected points aim to reduce fatigue and improve sleep quality. The applied pressure ranges from 3 to 5 kilograms and is administered by a trained researcher.
Category
Rehabilitation
2
Description
Control group: The intervention is similar to group 1 but pressure is applied on sham points with no therapeutic effect, serving as placebo control.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 4, Khomein County
Full name of responsible person
Marzieh Mousivand
Street address
Khodarahm Shahgholi Alley, Vahidi Street, Emam Khomeini Boulevard, Khomein County, Markazi Province, Iran
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mousivand.marzieh@gmail.com
2
Recruitment center
Name of recruitment center
Health Center No. 2, Khomein County
Full name of responsible person
Marzieh Mousivand
Street address
Fazilat Street, Khomein County, Markazi Province, Iran
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mousivand.marzieh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Dr.Saeed Amini
Street address
Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
info@khomeinums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein 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
Khomein University of Medical Sciences
Full name of responsible person
Marzieh Mousivand
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mousiavandmarzieh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Dr. Mahdi Safarabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mahdisafarabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Marzieh Mousivand
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khomein University of Medical Sciences, Ghods Boulevard, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
mousivandmarzieh@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available