Protocol summary

Summary
The purpose of study is to determine the appropriate educational program for improving communication skills, controlling and managing stress by emergency medical assistants. This study will be done in Rasoul-e-Akram Hospital in 2016. Initially, communication skills and information transmission by the assistance using the SPIKES tool will examine. The study population were emergency medical assistant of Iran University of Medical Sciences, 64 students will be randomly assigned to training groups, in a training program group GRIEV_ING and the other group Belgian interuniversity curriculum communication skills training (BIC-CST) presented until evaluate the effectiveness of each program in managing and transmitting bad news. Assessment of assistant’s skills were after-training, two and four weeks after the training. In addition, the director of the research team will monitor how to transmit bad news by the assistants and the behavioral characteristics, expression of the contents and the amount of stress they will monitor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017102228342N2
Registration date: 2017-10-25, 1396/08/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Mohammad Hosseini Kasnavieh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
hosseinikasnavieh.sm@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-09-28, 1396/07/06
Expected recruitment end date
2018-03-12, 1396/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine effective training program for improving relationship between patient and assistant in managing unpleasant consequences
Public title
Determine effective training program for improving relationship between patient and assistant
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All emergency medical assistants will be included in the study That training at Iran University of Medical Sciences Exclusion criteria: Exclusion criteria are not considered due to the importance of stress management and communication skills
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2017-09-13, 1396/06/22
Ethics committee reference number
IR.IUMS.REC 1396.31261

Health conditions studied

1

Description of health condition studied
problems related to primary support group, including family circumstances
ICD-10 code
Z63
ICD-10 code description
Z63.4, Z63.7, Z63, Z63.8

Primary outcomes

1

Description
Managing bad news transfer
Timepoint
Before starting the study and after-training, two and four weeks after the training
Method of measurement
SPIKES questionnaire

Secondary outcomes

1

Description
Setting interview
Timepoint
Before starting the study and after-training, two and four weeks after the training
Method of measurement
SPIKES Questionnaire

2

Description
Strategy
Timepoint
Before starting the study and after-training, two and four weeks after the training
Method of measurement
SPIKES Questionnaire

3

Description
Planning
Timepoint
Before starting the study and after-training, two and four weeks after the training
Method of measurement
SPIKES Questionnaire

4

Description
Professionalism
Timepoint
Before starting the study and after-training, two and four weeks after the training
Method of measurement
SPIKES Questionnaire

5

Description
Empathy
Timepoint
Before starting the study and after the intervention
Method of measurement
SPIKES Questionnaire

6

Description
Knowledge
Timepoint
Before starting the study and after-training, two and four weeks after the training
Method of measurement
SPIKES Questionnaire

7

Description
Invitation
Timepoint
Before starting the study and after-training, two and four weeks after the training
Method of measurement
SPIKES Questionnaire

Intervention groups

1

Description
The GRIEVING training group is in five sessions two hours (10 hours) at once a week. The program of communication skills, control and management stress will also be held for 10 hours.
Category
Behavior

2

Description
The BIC-CST training program for 30 hours includes communication skills (10 sessions of three hours once week) and 10 hours are of control and management stress
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e Akram Hospital
Full name of responsible person
Mohammad Hosseini Kasnavieh
Street address
Niyayesh St, Sattar Khan St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Hosseini Kasnavieh
Position
Assistant
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6653 9233
Fax
Email
hosseinikasnavieh.sm@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Hosseini Kasnavieh
Position
Assistant
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6653 9233
Fax
Email
hosseinikasnavieh.sm@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Hosseini Kasnavieh
Position
Assistant
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6653 9233
Fax
Email
hosseinikasnavieh.sm@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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