Comparing the effect of acupressure on the SP6 point and foot reflexology on sleep quality and fatigue in patients with lukemia hospitalized in Imam khomeini Hospital in Urmia in 2022
Determining and comparing the effect of acupressure and foot reflexology massage on the quality of sleep and fatigue of leukemia patients admitted to Imam Khomeini Hospital Urmia in 1401
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 102 patients. For randomization, cards (a), (b) and (c) were used.
Settings and conduct
This study is a single blind clinical trial research with a pre-test-post-test design. It will be implemented in Urmia University of Medical Sciences, Urmia Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Consent of patients to participate in the study suffering from chronic lymphoid leukemia Age above 18 years and less than 80 years Ability to speak Persian
Intervention groups
In the acupressure group, in parallel with these routine cares, acupressure will be performed for each sample using the SP6 point for four weeks and every day (5 minutes) by the researcher. It should be mentioned that the researcher had personally attended all the necessary training related to acupressure and foot massage therapy from the complementary medicine specialist of Urmia University of Medical Sciences (Dr. Nozad; head of the Iranian Complementary Medicine Association) and received the necessary certificate. has done (appendix). In the foot massage therapy group, the intervention will be such that for the patients of this intervention group, after preparing the patient and greasing the soles of the feet with sweet almond oil, which is used for cold and wetness for all temperaments, every day for four consecutive weeks Reflexology is performed for 5 minutes on the treatment points on the soles of both feet. No intervention will be done in the control group and they will only receive routine ward care.
Main outcome variables
quality of sleep and fatigue of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042512N2
Registration date:2023-02-18, 1401/11/29
Registration timing:prospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Rasoul Goli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4853 3530
Email address
rasoulgoli94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-03-30, 1402/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of acupressure on the SP6 point and foot reflexology on sleep quality and fatigue in patients with lukemia hospitalized in Imam khomeini Hospital in Urmia in 2022
Public title
he effect of acupressure on the SP6 point and foot reflexology on sleep quality and fatigue in patients with lukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of patients to participate in the study
Conscious and oriented patients with stable health status
Suffering from chronic lymphoid leukemia
Age above 18 years and less than 80 years
Ability to speak Persian
Exclusion criteria:
Having chronic diseases such as diabetes, cardiovascular and respiratory diseases
Having mental disorders
receiving radiotherapy
Having an injury or surgery on the sole of the foot
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The selected samples will be divided into two intervention groups and one control group using simple random sampling method. The method of random allocation into three groups was done by taking the cards (a), (b) and (c) by the patients, and the researcher divided the samples into three groups using the cards (a), (b) and (c). Acupressure, sole reflex massage and control will be divided. In this way, the patients who were included in the study, if card (a) is removed, will be included in the acupressure group, card (b) will be included in the sole reflex massage group, and card (c) will be included in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in this study is single blind, so that the statistician is not aware of the study groups and the data analyst is not aware of which data are related to the intervention group and which data are related to the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Urmia University of Medical Sciences
Street address
Urmia, Resalat Blvd, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-11-08, 1401/08/17
Ethics committee reference number
IR.UMSU.REC.1401.296
Health conditions studied
1
Description of health condition studied
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
ICD-10 code
C81-C96
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
Sleep quality score In Pittsburgh Sleep Quality Index (PSQI)
Timepoint
Measurement of sleep quality score before the intervention and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
2
Description
Fatigue score of Cancer Fatigue Scale Questionnaire
Timepoint
Measuring the fatigue score before the intervention and one month after the intervention
Method of measurement
Fatigue score of Cancer Fatigue Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
FIRST Intervention group: In the acupressure group, in parallel with these routine cares, acupressure will be performed for each sample using the SP6 point for four weeks and every day (5 minutes) by the researcher.
Category
Prevention
2
Description
SECOND Intervention group: In the foot massage therapy group, the intervention will be such that for the patients of this intervention group, after preparing the patient and greasing the soles of the feet with sweet almond oil, which is used for cold and wetness for all temperaments, every day for four consecutive weeks Reflexology is performed for 5 minutes on the treatment points on the soles of both feet.
Category
Prevention
3
Description
Control group: No action is taken for the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Urmia
Full name of responsible person
Amireh Hassanpour
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 239 3134
Email
amirehhassanpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Amireh Hassanpour
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 239 3134
Email
َAmirehhassanpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
30
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
Oroumia University of Medical Sciences
Full name of responsible person
Amireh Hassanpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 239 3134
Email
Amirehhassanpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Amireh Hassanpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 239 3134
Email
Amirehhassanpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Amireh Hassanpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Urmia, Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 914 239 3134
Email
Amirehhassanpour@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Descriptive analyzes are allowed on the submitted dat
From where data/document is obtainable
corresponding autho
What processes are involved for a request to access data/document
The request email should be sent to the corresponding author