Determination of the Effect of Foot Reflexology on Stress, Anxiety, Depression and Cortisol Serum Levels in Hemodialysis Patients at Hazrat Abolfazl Minab Hospital, 1397
Design
Clinical trial with community-based and pragmatic control group, with parallel group, one-blind, non-randomized
Settings and conduct
This study will be conducted at Abolfazl Minab Hospital.The sampling method was randomly divided into two intervention and control groups on paired and individual days. Then, based on entry and exit criteria, 30 individuals in each group were randomly selected.Blindness: We do not tell patients, doctors and nurses that patients are divided into control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Dialysis for at least 3 months and at least 3 times a week
2- Having written consent to participate in the study no use of other or complementary therapies
3-The absence of limb amputation or ulcer at the site of reflexology
4- Not having a history of taking relaxing medications and antidepressants
؛Exclusion criteria:
1- During the study, refer to kidney transplants or peritoneal dialysis
2- Hemodynamic complications in most dialysis sessions
3- Absent more than three sessions
Intervention groups
Intervention group: With the thumb on pressure points directly to the solar plexus and this is done 3 times a week for 4 weeks each session for 15 minutes per foot (6 minutes of pressure and 3 minutes rest and again 6 minutes of pressure) and rotationally and with the pressure applied to the patient's tolerance.
Control group: By creating the same conditions with the intervention group, simple massage of the foot without compression of the standard reflexology massage points is performed with the same duration as the intervention group.
Investigating the Effect of Foot Reflexology on Stress, Anxiety, Depression and Serum Cortisol levels in Hemodialysis Patients
Public title
The Effect of Foot Reflexology on Stress, Anxiety, Depression and Serum Cortisol levels in Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years
Dialysis for at least 3 months and at least 3 times a week, each time for 4-3 hours
The absence of limb amputation or ulcer at the site of reflexology
Absence of chronic and debilitating disease(Cancer, Chronic Respiratory Failure, Heart Failure, Rheumatoid Arthritis, Lupus Erythematosus)
Not having a physical disability or a clear mental disorder that disables the patient in self-care
The absence of coagulation disorders(due to the possibility of clot and thromboembolism)
Not having a history of taking relaxing medications and antidepressants, cigarette and drug addiction
The absence of neuropathy in the feet
Not having a history of incident in the last 6 months
Having written consent to participate in the study
Non-use of other side therapies and complementary
Exclusion criteria:
Unwillingness to continue participation in study;
During the study, refer to kidney transplants or peritoneal dialysis;
Hemodynamic complications in most dialysis sessions;
Absence more than three sessions;
Death during the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients, doctors and nurses do not say which patients are in the control or intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Central Office of Medical Sciences,Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.RUMS.REC.1397.049
Health conditions studied
1
Description of health condition studied
stress
ICD-10 code
Z63.7
ICD-10 code description
Anxiety (normal) about sick person in family Health problems within family Ill or disturbed family member Isolated family
2
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depression NOS Depressive disorder NOS
3
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
A disorder characterized by the essential descriptive features of a generalized anxiety disorder (F41.1), a panic disorder (F41.0), or a combination of both, but arising as a consequence of an organic disorder.
4
Description of health condition studied
Serum cortisol levels
ICD-10 code
E27.9
ICD-10 code description
Disorder of adrenal gland, unspecified
5
Description of health condition studied
Reflexology
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Hemodialysis
ICD-10 code
Z63.7
ICD-10 code description
Dialysis (renal) NOS
Primary outcomes
1
Description
Depression scores on standard questionnaires for depression, anxiety and stress 21 questions
Timepoint
Session before and after intervention
Method of measurement
Standard questionnaire for depression, anxiety and stress 21 questions(DASS-21)
2
Description
Anxiety scores on standard questionnaires for depression, anxiety and stress 21 questions
Timepoint
Session before and after intervention
Method of measurement
Standard questionnaire for depression, anxiety and stress 21 questions (DASS-21)
3
Description
Stress scores on standard questionnaires for depression, anxiety and stress 21 questions
Timepoint
Session before and after intervention
Method of measurement
Standard questionnaire for depression, anxiety and stress 21 questions
4
Description
Serum cortisol levels
Timepoint
Session before and after intervention
Method of measurement
enzyme-linked immunosorbent assay test (ELISA test)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the stages of reflextive massage are described. Participants are asked to lie on the hemodialysis bed and close their eyes and put themselves in a state of tranquility. Foot reflexology massage is done an hour after starting dialysis for 30 minutes (15 minutes for each foot), first for the left leg and then for the right one.To massage the feet, warm your hands.Hold the heel with the left hand and bending and straightening it from the ankle with push the planter. Then enter direct pressure with the thumb on the solar plexus and this is done 3 times a week for 4 weeks each session for 15 minutes per foot (6 minutes of pressure and 3 minutes rest and again 6 minutes of pressure) and rotationally and with the pressure applied to the patient's tolerance.
Category
Rehabilitation
2
Description
Control group: By creating the same conditions with the intervention group, simple massage of the foot without compression of the standard reflexology massage points is performed with the same duration as the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Abolfazl hospital
Full name of responsible person
Reza Hadizadeh
Street address
Boulevard Muhammad, Hazrat Abolfazl hospital
City
Minab
Province
Hormozgan
Postal code
7981693119
Phone
+98 76 4221 4120
Email
Hospital.minab@Gmail.com
Web page address
http://www.abmh.hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ahmad Reza Sayadi
Street address
Central Organization, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Web page address
http://www.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Zahra Shanbepour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Minab, Hormozgam
City
Minab
Province
Hormozgan
Postal code
7997193149
Phone
+98 76 4232 7277
Email
zahra.shanbpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Reza Sayadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Street, School of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34345900
Email
sayadiahmad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zahra Shanbepour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Minab, Hormozgam
City
Minab
Province
Hormozgan
Postal code
7997193149
Phone
+98 76 4232 7277
Email
zahra.shanbpour@yahoo.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