Determining the effect of recreational therapy application on fatigue and depression in hemodialysis patients
Design
Clinical trial with an intervention group and a control group in parallel without blinding, randomized using site www.randomization.com; on 60 patients.
Settings and conduct
The study was conducted on hemodialysis patients in Montaseriyeh Hospital and the patients completed the mentioned questionnaires before and after the implementation of the recreational therapy application programs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 60 years old; having full consciousness; having a mobile phone under the Android operating system; history of at least 2 months of hemodialysis; perform hemodialysis at least 2 to 3 times a week; not taking anti depression or drugs that effect; not having a history of mental illness. Exclusion criteria: unwillingness to participate in the study; occurrence of physical and mental disorders requiring treatment or hospitalization; death or travel of the participant during the research; failure to implement approved programs for at least days; obtaining a score higher than 19 according Beck depression questionnaire.
Intervention groups
Patients personal and medical characteristics, Beck depression and MFI fatigue questionnaires are completed at the beginning of the study. Then the application is installed on the patients mobile phone and patients is taught how to use it. Patients will perform all the programs specified in the application every day for 30 days. The researcher will follow up the patients on a daily basis through phone calls and also in person in term of the full implementation of the determined programs. After 30 days, Becks depression and MFI fatigue questionnaires will be completed again for patients.
Main outcome variables
Depression and Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220803055608N1
Registration date:2022-08-29, 1401/06/07
Registration timing:prospective
Last update:2022-08-29, 1401/06/07
Update count:0
Registration date
2022-08-29, 1401/06/07
Registrant information
Name
Moein Alishahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5229 0361
Email address
moeinnurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of recreational therapy application on fatigue and depression in hemodialysis patients
Public title
The effect of recreational therapy application on fatigue and depression in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Having full consciousness
Having a mobile phone under the Android operating system
A history of at least 2 months of hemodialysis
Perform hemodialysis at least 2 to 3 times a week
Not taking anti depression or drugs that effect
Not having a history of mental illness according to the patients statement or a history of taking psychiatric drugs
Exclusion criteria:
Unwillingness to participate in the study
Occurrence of physical and mental disorders requiring treatment or hospitalization
Death or travel of the participant during the research
Failure to implement approved programs for at least 10 days
Obtaining a score higher than 19 studies of the Beck depression questionnaire
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using the www.randomization.com site and the random sequences determined using a closet envelope are allocated to the study participants.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad School of Nursing and Midwifery
Street address
Qureshi building, Next to hoveyze cinema, Daneshgah street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2022-06-22, 1401/04/01
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.021
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
2
Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
3
Description of health condition studied
Chronic kidney disease (CKD)
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Depression score in Beck questionnaire
Timepoint
The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention
Method of measurement
Beck depression questionnaire
2
Description
Fatigue score in Multidimensional Fatigue Inventory (MFI) questionnaire
Timepoint
The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention
The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention
Method of measurement
Verbal numeric rate scale (VNRS)
2
Description
Quality of life
Timepoint
The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention
Method of measurement
Kidney disease quality of life (KDQOL-SF)
3
Description
Perceived stress
Timepoint
The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention
Method of measurement
Cohen perceived stress scale
Intervention groups
1
Description
Intervention group: After stating the objectives and obtaining informed consent from the samples, the patients are assured about the confidentiality of the information and publication of the results of the studies. Then the patients personal and medical characteristics, becks depression and MFI fatigue questionnaires are completed. After preparing and confirming the content of the recreational therapy application, in consultation with the informatics engineer the application will be prepared for the smartphone as standard in the android operating system. Then the application is installed on the patients mobile phone and patients is taught how to use it. Patients will perform all the programs specified in the application every day for 30 days. Using a checklist and based on the characteristics and date of entry into the study, the researcher will follow up the patients on a daily basis through phone calls and also in person in term of the full implementation of the determined programs. After 30 days, Becks depression and MFI fatigue questionnaires will be completed again for patients.
Category
Rehabilitation
2
Description
Control group: After stating the objectives and obtaining informed consent from the samples, the patients are assured about the confidentiality of the information and publication of the results of the studies. Then the patients personal and medical characteristics, becks depression and MFI fatigue questionnaires are completed. In this group, no intervention was performed nd only routine hospital nursing interventions were provided, including checking vital signs and injecting prescription drugs. After 30days, Becks depression and MFI fatigue questionnaires are completed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaseriyeh Hospital
Full name of responsible person
Moein Alishahi
Street address
25 Imam Khomeini Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137776788
Phone
+98 51 3229 1969
Email
Moeinnurse@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyyed Reza Mazloum
Street address
Daneshgah Street, Doctora Crossroad, Ebne sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mazlomr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Moein Alishahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ebne sina Street, Doctora Crossroad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Moeinnurse@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Moein Alishahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ebne sina Street, Doctora Crossroad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Moeinnurse@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Moein Alishahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ebne sina Street, Doctora Crossroad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Moeinnurse@gmail.com
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