Protocol summary

Study aim
The core of nursing is the communication between the nurses and patients. This is a professional relationship and based on a well-respected approach. One component of this relationship is empathy, which is often described as the ability to feel rather than the other person and from the point of view of others. From the point of view of care, empathy is the ability of accepting a patient and being in the mind of others. The importance of this issue in elderly people can be emphasized due to its population increase as its more vulnerable, in terms of physological,psychological,social and spiritual(all aspects of health). Anxiety is one of the most important issues and problems of the elderly, which needs special attention. Many studies have been conducted to reduce anxiety by nurses.But little insights have affected the nurs's empathy effect on old patient's anxiety and empathy perception that have been surveyed in this research.
Design
This study is a simple randomized clinical trial with pre-test and post-test design. In this study, 124 old patient admitted to adult surgical wards of Namazi Hospital were randomly assigned to the experimental group (62) and control group (n = 62). At the time of admission, they were asked to answer the questions of Jefferson and Spielberger anxiety questionnaire and demographic information. During the hospitalization period, for the test group, in addition to the usual care, the empathy intervention was carried out by the nurses.But contrl group received a routine care. At the time of discharge, the respondents in both groups answered the questionnaires and asked questions.
Settings and conduct
In this study, 124 old patient admitted to adult surgical wards of Namazi Hospital were randomly assigned to the experimental group (62) and control group (n = 62). At the time of admission, they were asked to answer the questions of Jefferson and Spielberger anxiety questionnaire and demographic information. During the hospitalization period, for the test group, in addition to the usual care, the empathy intervention was carried out by the nurses.But contrl group received a routine care. At the time of discharge, the respondents in both groups answered the questionnaires and asked questions.The nurse that helped all of patients for completing questionaires(outcome assessor)and all of patients didn't know which patient is in control or study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The person's willingness to participate in the study and physical ability to interview and answer the questions of the questionaires and 60 years old and more patients. Exclusion criteria: Cognitive disorders ( Alzheimer and dementia)and use of sedative medications or other methods of such as relaxation and meditation during the study and sedative medications or other methods of reducing anxiety such as relaxation and meditation during the study.
Intervention groups
In both groups,patients were over 60 years of age and they had admitted in surgical wards in Namazi Hospital and were willing to participate in the study with appropriate psychological conditions to participate in the research and answer questions.
Main outcome variables
analyzing the results of the research presents that the hidden anxiety of the members of both groups didn't have changed(in comparison between the time of the discharge and the time of admission and comparison between two groups.But the apparent anxiety of the research community significantly had decreased in both groups. However, these changes were not significant in comparison with the two groups.Patient's perception of nurse's empathy just had increased in experimental group significantly.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131117015426N6
Registration date: 2018-01-01, 1396/10/11
Registration timing: retrospective

Last update: 2018-01-01, 1396/10/11
Update count: 0
Registration date
2018-01-01, 1396/10/11
Registrant information
Name
Maryam Hazrati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 3949
Email address
hazratim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-10-23, 1396/08/01
Trial completion date
empty
Scientific title
The effect of nurse’s empathy on perceived empathy and anxiety among the elderly patients.
Public title
The effect of nurse’s empathy on the elderly patients.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The person's willingness to participate in the study. Physical ability to interview and answer the questions of the questionaires.
Exclusion criteria:
known case of cognitive disorders ( Alzheimer and dementia). use of sedative medications or other methods of such as relaxation and meditation during the study. Use of sedative medications or other methods of reducing anxiety such as relaxation and meditation during the study.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 124
More than 1 sample in each individual
Number of samples in each individual: 2
In this study,patient's perceived empathy and patient's anxiety assessed.
Actual sample size reached: 124
More than 1 sample in each individual
Actual sample size in each individual: 2
In this study,patient's perceived empathy and patient's anxiety assessed.
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a simple randomized clinical trial with pre-test and post-test design. In this study, 124 old patient admitted to adult surgical wards of Namazi Hospital were randomly assigned to the experimental group (62) and control group (n = 62). At the time of admission, they were asked to answer the questions of Jefferson and Spielberger anxiety questionnaire and demographic information. During the hospitalization period, for the test group, in addition to the usual care, the empathy intervention was carried out by the nurses.But contrl group received a routine care. At the time of discharge, the respondents in both groups answered the questionnaires and asked questions.
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurse that helped all of patients for completing questionaires(outcome assessor)and all of patients didn't know which patient is in control or study group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University Of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
IR.SUMS.REC.1395.144

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

2

Description of health condition studied
empathy perception
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
empathy perception score with Jefferson questionaire
Timepoint
patient's admission and discharge times
Method of measurement
Jefferson patient's empathy perception questionaire(JSPPE)

2

Description
anxiety score with spilberger questionaire
Timepoint
patient's admission and discharge times
Method of measurement
anxiety spilberger questionaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazee hospital
Full name of responsible person
Mehdi Maher
Street address
Namaze hospital, Namazee square, Zand street,Shiraz
City
Shiraz
Province
Fars
Postal code
7185917479
Phone
+98 71 3647 4256
Email
hazrati@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Basir Hashemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7185917479
Phone
+98 71 3647 4254
Email
hazratishirazy@gmail.com
Grant name
Shiraz University of Medical Ssiences,Vice Chancellor for Research Affairs
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Hazrati
Position
Professor assistant
Latest degree
Ph.D.
Other areas of specialty/work
پرستاری سالمندی
Street address
Namazi square
City
Siraz
Province
Fars
Postal code
13119-71936
Phone
+98 71 3647 4254
Fax
Email
hazratim@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Hazrati
Position
Professor assistant
Latest degree
Ph.D.
Other areas of specialty/work
Geriatric nursing
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
13119-71936
Phone
+98 71 3647 4252
Email
hazratim@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Ghanee
Position
post graduate student in geriatric nursing
Latest degree
Master
Other areas of specialty/work
Psychiatrics
Street address
Modarres
City
Shiraz
Province
Fars
Postal code
71578-68564
Phone
+98 71 3720 2720
Email
ghanefa258@gmail.com

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
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