Determining the effect of group discussion based on Cognitive-behavioral Intervention on alexithymia in hemodialysis patients in Goldis Hospital of Shahinshahr
Design
A clinical trial with a control group, with parallel-group design, With a sample size of 50 patients, without blindness, randomized through a throw Coins
Settings and conduct
This study will be performed in the dialysis ward of Goldis Hospitals in Shahinshahr. Subjects will be selected Using available sampling, and randomly assigned to intervention and control groups using a random number table. The samples of both groups will complete the Toronto alexithymia Questionnaire. For the intervention group, a group discussion based on cognitive-behavioral interventions will be conducted. The post-test was taken one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Consent to participate in research and having cooperation; A history of hemodialysis for 6 months or more; Lack of treated mental illnesses such as schizophrenia, paranoia, and anxiety.
Exclusion criteria:
Under 18 and over 60 years; Participation in previous same care program in the last three months; Get a score below 50 on the Toronto Alexithymia Scale
Intervention groups
Intervention group: In the intervention group 8 sessions of group discussion based on cognitive-behavioral interventions including mood, self-confidence, emotion expression, and emotion control will be conducted in the waiting room of the dialysis ward. The control group receives routine care.
Main outcome variables
Alexithymia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191015045120N1
Registration date:2019-12-14, 1398/09/23
Registration timing:registered_while_recruiting
Last update:2019-12-14, 1398/09/23
Update count:0
Registration date
2019-12-14, 1398/09/23
Registrant information
Name
Shirin Jafariandehaghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4001
Email address
shirin.jafarian347@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group discussion based on Cognitive-behavioral Intervention on alexithymia in hemodialysis patients in Goldis Hospital of Shahinshahr
Public title
The effect of group discussion based on Cognitive-behavioral Intervention on alexithymia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
consent to participate in research and having cooperation
A history of hemodialysis for 6 months or more
Lack of treated mental illnesses such as schizophrenia, paranoia, and anxiety
Exclusion criteria:
Under 18 and over 60 years
Patients' participation in group discussion based on cognitive behavioral interventions in the last three months
Get a score below 50 on the Toronto Alexithymia Scale
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)
Randomized
Randomization description
A simple randomization method was used for randomization. Firstly, all eligible patients were selected based on the criteria of entry and assigned a special code. Then, according to the sample size and the same number, the coin was thrown, and the heads subjects in the intervention group and the tails subjects in the control group.
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 Islamic Azad University Isfahan (Khorasgan) Branch
Street address
Ahmad Abad St, Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.216
Health conditions studied
1
Description of health condition studied
Dialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Alexithymia
Timepoint
Before and one month after intervention
Method of measurement
Toronto Alexithymia Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group 8 sessions of group discussion based on cognitive behavioral interventions including mood, self-confidence, and emotion expression and emotion control will be conducted in the waiting room of dialysis ward. The control group receives routine care.
Category
Behavior
2
Description
Control group: the control group will receive routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahinshahr Goldis Hospital
Full name of responsible person
Shirin Jafariandehaghani
Street address
Hospital Blvd, Goldis town
City
Shahinshahr
Province
Isfehan
Postal code
8315621546
Phone
+98 31 4526 0801
Email
shirin.jafarian347@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University Isfahan (Khorasgan) Branch