Determine of the effect of Guided Imagery on stigma and emotion regulation in Hemodialysis patients
Design
This study is a clinical trial with two groups (intervention and control), double blinded (the data analyst and participants) and randomized, with 28 patients in each group.
Settings and conduct
This double-blind study (data analyst and participants) will be conducted in the dialysis department of Samen-al-Hojaj Hospital in Sirjan. In the intervention group, 16 guided imagery sessions will be conducted over the course of 4 weeks with 2 sessions per week at two different times in the morning (between 9-8) and afternoon (between 21-20). Variables will be measured before and immediately after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Full consciousness؛ acceptable ability to hear؛ see and speak؛ Have ability to read and write in Persian language؛ A history of at least six months of hemodialysis twice a week (each session lasting at least 3 hours)؛ No kidney transplantation, the use of peritoneal dialysis, and ultimately the patient passing away during the course of the study؛ No previous experience use of relaxation techniques (including Guided Imagery)؛ No use of sedatives, antidepressants and narcotics
Intervention groups
In the intervention group, 16 guided imagery sessions will be conducted over the course of 4 weeks with 2 sessions per week at two different times in the morning (between 9-8) and afternoon (between 21-20), while patients in the control group will receive usual care. Cognitive emotion regulation and stigma scores will be measured before and immediately after the intervention.
Main outcome variables
Emotion regulation ,Stigma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024919N17
Registration date:2024-03-22, 1403/01/03
Registration timing:retrospective
Last update:2024-03-22, 1403/01/03
Update count:0
Registration date
2024-03-22, 1403/01/03
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of effectiveness of guided imagery on stigma and emotion regulation in hemodialysis patients
Public title
Effect of guided imagery on stigma and emotion regulation in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness
Acceptable ability to hear, see and speak
Have ability to read and write in Persian language
A history of at least six months of hemodialysis twice a week (each session lasting at least 3 hours)
Exclusion criteria:
Kidney transplantation, the use of peritoneal dialysis, and ultimately the patient passing away during the course of the study
Previous experience use of relaxation techniques (including Guided Imagery)
Use of sedatives, antidepressants and narcotics
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate individuals under study into intervention and control groups, a randomized block design is used. Randomized block design is a method in which participants are randomized within blocks based on factors such as family history of dialysis, number of dialysis sessions per week, duration of kidney disease, primary cause of kidney failure, etc. Subsequently, using simple randomization method and R software, half of the individuals from each group are assigned to the intervention group and the other half to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Given that the intervention takes place at home; this study is double-blind. the data analyst do not know which data is related to the intervention group and which data is related to the control group, and participants do not know in which intervention or control group they were placed.
Placebo
Not 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
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-10-31, 1402/08/09
Ethics committee reference number
IR.KMU.REC.1402.282
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Hemodialysis
Primary outcomes
1
Description
Emotion regulation
Timepoint
Emotion regulation will be measured before the intervention, immediately after the intervention (at the end of the fourth week)
The severity of stigma will be measured before the intervention, immediately after the intervention (at the end of the fourth week)
Method of measurement
Stigma Scale for Chronic Illness 8-Items (SSCI-8)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 16 sessions of guided imagery will be performed in 4 weeks and two sessions per week in two turns at the morning (between 08:00 and 09:00) and in the evening (between 20:00 and 21:00). Morning and evening sessions will be held at the patient's home. Patients will listen to the Audio- Recorded Guided Imagery Script for 25 minutes via headphone and will follow the instructions. Also, disturbing noises will be controlled through meetings formation in quiet rooms. Also at home, it is attempted to allocate a room for the patient to listen to the Audio-Recorded Guided Imagery Script with the coordination of the patient and the family.
Category
Other
2
Description
Control group: Control group: Patients in the control group received routine cares.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Samen al-Hojaj Medical Education Hospital
Full name of responsible person
Batool Tirgari
Street address
Hajrat Boulevard, located between Seyyed Ahmad Khomeini Boulevard and Behesht Zahra Boulevard.
City
Sirjan
Province
Kerman
Postal code
7816916338
Phone
+98 34 3234 0301
Email
B_tirgari@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
DR Batool Tirgari
Street address
Razi Nursing and Midwifery School, Medical Sciences Campus, Haft baghe alavi Road, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
B_tirgari@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
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
batool tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
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