Protocol summary

Summary
Objectives: To assess the effect of communication skills training of personnel versus no training on satisfaction in patients with gynecologic disorders. Design: a randomized clinical trial. Setting and conduct: ٍEighty-four eligible personnel who are working in Fatemieh Hospital will be enrolled into the trial. Inclusion criteria: (a) official personnel of the hospital; (b) age of 20 to 65 years; (c) being female. Exclusion criteria: (a) dissatisfaction; (b) non-official personnel (being student). Intervention group: Communication skills training one hour session a week for one month. Control group: No training. Primary outcome: (a) assessing the communication skills before and one month after intervention using Burton questionnaire; (b) Patients' satisfaction before and one month after intervention using questionnaire Secondary outcome: Nothing. Randomization: Random assignment of the personnel to the intervention and control groups one at a time. Blinding: Not possible.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508259014N76
Registration date: 2015-09-07, 1394/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-07, 1394/06/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-06-15, 1394/03/25
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of communication skills training of personnel versus no training on satisfaction from personnel behavior in patients with gynecologic disorders: a randomized clinical trial
Public title
Communication skills training effect on satisfaction of patients with women diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) official personnel of the hospital; (b) age of 20 to 65 years; (c) being female. Exclusion criteria: (a) dissatisfaction; (b) non-official personnel (being student).
Age
From 20 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the personnel to the intervention and control groups one at a time. Blinding: Not possible.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.UMSHA.REC.1394.275

Health conditions studied

1

Description of health condition studied
Gynecological disorders
ICD-10 code
N94.9
ICD-10 code description
Unspecified condition associated with female genital organs and menstrual cycle

Primary outcomes

1

Description
Assessing the communication skills
Timepoint
before and after intervention
Method of measurement
using Burton questionnaire

2

Description
Patients' satisfaction
Timepoint
before intervention and one month later
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
No training
Category
Other

2

Description
Communication skills training one hour session a week for one month
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Marzieh Otogara
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Marzieh Otogara
Position
Health Education PhD Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
m_otogara@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences, School of Medicine
Full name of responsible person
Dr Zohreh Ababzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
z_abab_2003@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.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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