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The effect of foot reflexology on sexual function and sexual quality of life in patients undergoing hemodialysis in Imam Reza Hospital in Sirjan in 2020

Protocol summary

Study aim
The effect of foot reflexology on sexual function and sexual quality of life in patients undergoing hemodialysis
Design
Clinical trial with intervention and sham groups, with parallel groups, one-way blind, randomized block method, on 60 patients. Block building using online software
Settings and conduct
The research environment will be Imam Reza (AS) Hospital in Sirjan. After obtaining informed written consent from the patient, information related to demographic characteristics, sexual function and quality of sexual life will be obtained through interviews in both intervention and sham groups. By assigning a specific number to each of the subjects, the person evaluating the consequences of the intervention is blinded because he does not know which person has been subjected to which type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 18 to 65 years, no use of drugs for sexual problems, at least 3 months have passed since the beginning of their dialysis, at least 3 times a week and 4 hours each time hemodialysis, there is no medical prohibition to intervene Be, not suffering from debilitating diseases, being married and living with a spouse, no mental problems No entry conditions: Having any medical disorders while studying, death of spouse or divorce, non-intervention in three consecutive sessions
Intervention groups
Intervention group: Hemodialysis patients undergoing reflexology intervention. In addition to routine care, the foot reflexologist will receive dialysis for 4 weeks, 3 times a week for 30 minutes each (15 minutes per foot). In the sham or facade treatment group, non-specific foot massage will be performed without squeezing the standard points of reflexology with the same conditions and duration as the intervention group.
Main outcome variables
sexual function ؛ sexual quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200712048085N1
Registration date: 2020-07-15, 1399/04/25
Registration timing: prospective

Last update: 2020-07-15, 1399/04/25
Update count: 0
Registration date
2020-07-15, 1399/04/25
Registrant information
Name
Somayeh Zeidabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4220 8049
Email address
somayeh.zeidabadi65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on sexual function and sexual quality of life in patients undergoing hemodialysis in Imam Reza Hospital in Sirjan in 2020
Public title
The effect of foot reflexology on sexual function and sexual quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 65 years Do not use the drug for sexual problems At least 3 months have passed since the start of their dialysis Have hemodialysis at least 3 times a week for 4 hours each time Medically, there is no barrier to surgery, such as foot ulcers, impotence, and orthopedic problems Lack of debilitating and chronic diseases such as (cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus erythematosus) Being married and living with a spouse Lack of known psychological problems such as depression and bipolar disorder according to the patient's self-expression
Exclusion criteria:
Having any medical disorders during the study that prevent reflexology (such as diabetic foot ulcers, etc.) Death of spouse or divorce Failure to intervene in three consecutive sessions
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be used to assig samples to two groups (foot and sham reflexology). Blocking will be done using online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The size of the blocks will be 6. Using the lottery, each group will be assigned a label A, B, and then the samples will be assigned to each group based on a random block list.
Blinding (investigator's opinion)
Single blinded
Blinding description
By assigning a specific number to each of the subjects, the person evaluating the consequences of the intervention is blinded because he or she does not know which person has been subjected to which type of intervention
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
The beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-07-06, 1399/04/16
Ethics committee reference number
IR.KMU.REC.1399.248

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
sexual function
Timepoint
mmediately and one month after the intervention (reflexology)
Method of measurement
Rosen et al.'s sexual function questionnaire for men and women

2

Description
sexual quality of life
Timepoint
mmediately and one month after the intervention (reflexology)
Method of measurement
Men and women sexual quality of life questionnaire(SQOL-F, SQOL-M)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to routine care, the intervention group will receive foot reflexology for 4 weeks, 3 times a week for 30 minutes each time (15 minutes per foot) during dialysis.
Category
Rehabilitation

2

Description
Control group: Control group: Non-specific foot massage will be performed without squeezing the standard points of reflexology with the same conditions and duration as the intervention group (for 4 weeks and 3 times a week for 30 minutes each time (15 minutes per foot)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Sirjan
Full name of responsible person
Somayeh Zeidabadi Nejad
Street address
Quds Street
City
Sirjan
Province
Kerman
Postal code
7815716373
Phone
+98 34 4220 8049
Email
somayeh.zeidabadi65@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pardakhti Abbas
Street address
Kerman, Tahmasbabad intersection, beginning of Ibn Sina St., Vice Chancellor for Research and Technology, Research Management
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Somayeh Zeidabadi Nejad
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Quds, Alley 12, No. 34
City
Sirjan
Province
Kerman
Postal code
7815716373
Phone
+98 34 4220 8049
Email
somayeh.zeidabadi65@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahlagha Dehghan Anaraki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Razi School of Nursing and Midwifery
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
m_dehghan86@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayeh Zeidabadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Qods Street, Alley No. 12, No. 34
City
Sirjan
Province
Kerman
Postal code
7815716373
Phone
+98 21 4220 8049
Email
somayeh.zeidabadi65@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The clinical report of this study will be presented in the form of an article.
When the data will become available and for how long
2 years
To whom data/document is available
researchers
Under which criteria data/document could be used
No specific conditions are defined.
From where data/document is obtainable
Thesis author
What processes are involved for a request to access data/document
Satisfaction of the main researcher
Comments
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