Examine the effect of group hope therapy on anxiety and medication adherence of hemodialysis patients
Design
Randomized clinical trials without control group and blinding
Settings and conduct
Group therapy on hemodialysis patients without blinding in a semi-experimental study before and after (without independent control group). In shahid rahimey and shohadaey asheir khoramabaf
Participants/Inclusion and exclusion criteria
The patients are within the age limit of 18-65. The patient should be interested in the research and in participating in the training sessions. The patient has undergone hemodialysis for one month. The patient should not suffer from mental disorders. The patient has not taken Psychiatric medicines. Patients’ anxiety score that is higher than the anxiety level should be trivial
Lack of patients’ interest in continuing the research. The use of anxiety-reducing medicines or other therapies for anxiety . Having severe anxiety disorders such as phobia and panic attack during dialysis .Patient death. Patient emigration. Having visual, hearing, and speech impairment
Intervention groups
This study doesn’t have a control group. It will be conducted with one group of hemodialysis patients. Group hope therapy will be conducted with five hemodialysis patients in each group. The contents of the hope therapy sessions are based on hope therapy protocol. The hope therapy is conduced weekly in 8 sessions, each lasting 60 minutes. Then, the effects of group hope therapy on state and trait anxiety and follow-up treatment will be examined one month and then three months later.
Main outcome variables
Determining the effect of treatment on apparent and hidden anxiety and compliance with the treatment of hemodialysis patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180628040273N1
Registration date:2018-10-31, 1397/08/09
Registration timing:retrospective
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Zahra Ahmadi fajr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3320 4517
Email address
zhraahmdy669@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-05, 1396/11/16
Expected recruitment end date
2018-09-16, 1397/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group hope therapy on anxiety and medication adherence of hemodialysis patients
Public title
The effect of group hope therapy on anxiety and medication adherence of hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patients are within the age limit of 18-65
The patient should be interested in the research and in participating in the training sessions.
The patients have undergone hemodialysis for one month.
The patients should undergo hemodialysis 3 times a week.
A doctor should introduce the patient to participate in the study
The patient should not suffer from mental disorders
The patients have not taken Psychiatric medicines
The patients should promise not to use other methods for decreasing anxiety during the hope therapy.
The patients should be able to participate in all of the group hope therapy sessions
Patients’ anxiety score that is higher than the anxiety level should be trivial
Exclusion criteria:
Lack of patients’ interest in continuing the research
The use of anxiety-reducing medicines or other therapies for anxiety
Having chronic and debilitating diseases based on doctor’s diagnosis
Having severe anxiety disorders such as phobia and panic attack during dialysis
Patient death
Patient emigration
Having visual, hearing, and speech impairment
Patients not being in good physical condition
Being absent for sessions
Not being able to participate in hope therapy sessions during the research
Changing the treatment approach(kidney transplant, peritoneal dialysis)
Severe family and social crises ( the death of a member of the immediate family, job, divorce, dropout)
Participating and following other training programs which affects anxiety.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan Univercity Medical Sience
Street address
Moalem ave.Anooshirvan rezaei str.
City
Khoramabad
Province
Lorestan
Postal code
6813833649
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.LUMS.REC.1396.356
Health conditions studied
1
Description of health condition studied
hemodialysis -patient
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
score anxiety the hidden and on the basis of a questionnaire, anxiety eshpilberger
Timepoint
Before the start of the intervention, immediately after the intervention and one months after the interventiond and three months after the intervention
Method of measurement
Scale obtained from Spielberger's revealing and hidden anxiety questionnaire
Secondary outcomes
1
Description
The score of medication adherance in the hemodialysis patients to the questioneria ESRD-AQ
Timepoint
Before the start of the intervention, immediately after the intervention and one month after the intervention and three months after the intervention
Method of measurement
the result of the questionnaire was to follow the treatment of hemodialysis patients according to the questionnaire - ESRD-AQ
Intervention groups
1
Description
This study doesn’t have a control group. It will be conducted with one group of hemodialysis patients. Group hope therapy will be conducted with five hemodialysis patients in each group. The contents of the hope therapy sessions are based on hope therapy protocol. The hope therapy is conduced weekly in 8 sessions, each lasting 60 minutes. Then, the effects of group hope therapy on state and trait anxiety and follow-up treatment will be examinedimmediatly after intervention and one month and then three months later.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis centers of the martyrs hospital in Khorramabad city
Full name of responsible person
Zahra Ahmadi Fajr
Street address
Ave Enghelab Shohada ashayer Hospital
City
Khoramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3323 6404
Email
Zhraahmdy669@gmail.com
2
Recruitment center
Name of recruitment center
Hemodialysis Center of Shahid Rahimi Hospital in Khorramabad
Full name of responsible person
Zahra Ahmadi Fajr
Street address
Ave Mojahedin, Azadi square
City
Khoramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3333 6150
Email
Zhraahmdy669@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Ahmadifajr
Street address
Enghelab Ave.Razi Ave. 1Arrasteh Alley. No99
City
Khoramabad
Province
Lorestan
Postal code
۶۸۱۶۸۴۹۴۴۹
Phone
+98 66 3320 4517
Email
Zhraahmdy669@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
2
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Tolabi Tahere
Street address
Khorramabad University of Medical Sciences . Km 5 Khorramabad .Complex Campus
City
Khoramabad
Province
Lorestan
Postal code
۶۸۱۳۸-۳۳۹۴۶
Phone
+98 66 3312 0138
Fax
+98 66 3312 0140
Email
pr@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Fajr
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No99, 1 Arahsteh Alley, Razi Ave, Enghelab Ave
City
Khoramabad
Province
Lorestan
Postal code
6816849449
Phone
+98 66 3320 4517
Email
Zhraahmdy669@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Fajr
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No99, 1 Arasteh Alley,Razi Ave,Enghslab Ave
City
Khoramabad
Province
Lorestan
Postal code
6816849449
Phone
+98 33204517
Email
zhraahmdy669@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Fajr
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No99, 1 Arahsteh Alley, Razi Ave, Enghelab Ave
City
Khoramabad
Province
Lorestan
Postal code
6816849449
Phone
+98 66 3320 4517
Email
Zhraahmdy669@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
Yes - There is 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
Information related to the main outcome and final result of the impact of therapeutic intervention on variables shared
When the data will become available and for how long
The start of the course access 3moonnth after printing results
To whom data/document is available
Researchers working in academic institutions, and scientific
Under which criteria data/document could be used
If you have a confirmation of the direction of the Run of the Protocol therapy of the scientific institutions
From where data/document is obtainable
Zahra ahmadifajr
Zhraahmdy@gmail.com
09384580853
What processes are involved for a request to access data/document
Ask the person the applicant until finally a week later from the knowledge of its authenticity for them to be sent