Investigating the effect of an educational program based on emotion regulation on death anxiety and psychological disturbance of patients undergoing chemotherapy
Determining the effect of a training program based on emotion regulation on death anxiety and psychological disturbance of patients undergoing chemotherapy
Design
Clinical trial with control group, with parallel groups, randomized, on 60 patients. Random allocation software is used for randomization.
Settings and conduct
The current research is a clinical trial with a pre-test and post-test design in the form of two test and control groups, which will be carried out on 60 patients with leukemia referred to Seyed al-Shohada Hospital who are being treated with chemotherapy. After obtaining the necessary permits from Isfahan University of Medical Sciences, the samples will be selected using available sampling method and then they will be randomly assigned to two intervention and control groups. The intervention group will participate in six training sessions based on emotion regulation during three weeks in a virtual way using smartphones.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Leukemia patients undergoing chemotherapy
Having a smart phone and being able to work with it
Exclusion criteria:
Having mental retardation, blindness and deafness
Intervention groups
Intervention group: In 6 sessions, they will receive emotion regulation training using a smartphone through the WhatsApp social network. And the control group will receive the prescribed routine treatments during this period. The interventions include 6 emotion regulation training sessions based on the Grass model, which are held virtually (two sessions per week). The duration of each session is 60 minutes. that the multimedia files designed using the social network will be provided to the participants.
Control group: only the questionnaires before and after the study are completed.
Main outcome variables
Death anxiety, psychological disturbance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020108N5
Registration date:2022-09-07, 1401/06/16
Registration timing:prospective
Last update:2022-09-07, 1401/06/16
Update count:0
Registration date
2022-09-07, 1401/06/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 2856
Email address
musarezaie@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of an educational program based on emotion regulation on death anxiety and psychological disturbance of patients undergoing chemotherapy
Public title
Investigating the effect of a training program based on emotion regulation on death anxiety and psychological disturbance
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have leukemia and are undergoing chemotherapy.
Have a good general condition to complete the questionnaire.
Having a smart mobile phone and the ability to work with it
Exclusion criteria:
Unwillingness to participate in the study
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is of size 4. Randomization unit: individual. Randomization tool: random allocation software. Hiding the random chain is by placing patient codes in opaque envelopes.
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
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, central headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.069
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia
Primary outcomes
1
Description
death anxiety
Timepoint
Immediately before and three weeks after the start of the study
Method of measurement
Templer Death Anxiety Scale
Secondary outcomes
1
Description
psychological distress
Timepoint
Immediately before and three weeks after the start of the study
Method of measurement
Kessler psychological distress questionnaire
Intervention groups
1
Description
Intervention group: In 6 sessions, they will receive emotion regulation training using a smartphone through the WhatsApp social network. And the control group will receive the prescribed routine treatments during this period. The interventions include 6 emotion regulation training sessions based on the Grass model, which are held virtually (two sessions per week). The duration of each session is 60 minutes. that the multimedia files designed using the social network will be provided to the participants. In order to evaluate the commitment of the participants to the sent content, they will be investigated using telephone follow-up. The intervention is carried out by a senior psychiatric nurse who has the necessary skills to provide an emotion regulation program and has previously conducted intervention studies in this field.
Category
N/A
2
Description
Control group: no intervention is done by the researcher for the control group, and only immediately before the study and three weeks after the start of the study, the questionnaires are completed by the patients of the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed al-Shohda Hospital, Isfahan
Full name of responsible person
Amir Musarezaie
Street address
Motahari street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Nursing faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Nursing faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Nursing faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.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