The effect of comfort- based nursing cares on their perception of nursing care behaviors and comfort level among patients undergoing open heart surgery
This study is a randomized controlled clinical trial and research environment is intensive care unit at the Golestan heart center in the Kordkoy town. The aim of study is to determine the effects of comfort centered care on patients’ comfort and patients’ perception of nursing care behaviors in open-heart surgery patient. Sample size is determined through a pilot study. Then patients who are selected based on inclusion criteria will be randomly allocated to experimental and control groups. Randomization will be done through block randomization. Totally 70 patients will be enrolled.
Interventions: intervention group will receive planned care including reflexotherapy and open heart surgery care education through face-to-face education and pamphlets and modification of environmental factors. All interventions will be done at a fixed time in each day during six consecutive days and patients will complete HCQ and CBI questionnaires 24 hour six days after surgery and intervention. Control group will receive only routine care. Inclusion criteria: being at the age of 25 to 60 years; the willingness to participate in the study; signing an informed consent; complete consciousness of the patient; not being emergency surgery, the ability to make a verbal communication; the ability to read and write; there are no scratches, scars, corn, infection or any loss and damage in the feet; no history of mental illness or addiction and absence of vision or hearing impairments; PTT in the range of 30 to 60.
The main outcomes in this study are comfort level and its dimensions and patients' perception of care behaviors and its dimensions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032733153N1
Registration date:2017-04-16, 1396/01/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-16, 1396/01/27
Registrant information
Name
Fatemeh Sheikhy
Name of organization / entity
Birgand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1410
Email address
fa.sheikhy@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Birgand University of Medical Sciences and Investigator
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of comfort- based nursing cares on their perception of nursing care behaviors and comfort level among patients undergoing open heart surgery
Public title
The effect of comfort- based nursing cares on the perception of care behaviors and comfort
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being at the age of 25 to 60 years; the willingness to participate in the study; signing an informed consent; complete consciousness of the patient; not being emergency surgery, the ability to make a verbal communication; the ability to read and write; there are no scratches, scars, corn, infection or any loss and damage in the feet; no history of mental illness or addiction and absence of vision or hearing impairments; PTT in the range of 30 to 60.
Age
From 25 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
allocate patients to permutation blocking manner to experimental and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birgand University of Medical Sciences
Street address
Birgand University of Medical Sciences; Ayatollah Ghaffari street; Birjand; South Khorasan
City
Birgand
Postal code
9717853577
Approval date
2017-01-02, 1395/10/13
Ethics committee reference number
IR.bums.REC.1395.232
Health conditions studied
1
Description of health condition studied
open heart surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Patients' perception of nursing care behaviors
Timepoint
24 hour after surgery and before intervention and six days after intervention
Method of measurement
Caring Behavior Inventory Questionnaire
2
Description
Comfort
Timepoint
24 hour after surgery and before intervention and six days after intervention
Method of measurement
Hospice comfort questionnaire
Secondary outcomes
1
Description
comfort Physical dimension
Timepoint
24 houre after surgery and before the intervention and after the intervention in Six days.
Method of measurement
score of Physical Dimension of comfort questionnaire
2
Description
comfort psycological dimension
Timepoint
24 houre after surgery and before the intervention and after the intervention in Six days.
Method of measurement
score of psycological Dimension of comfort questionnaire
3
Description
Comfort environmental dimension
Timepoint
24 hour after surgery and before the intervention and after the intervention on sixth day.
Method of measurement
Score of environmental Dimension of comfort questionnaire
4
Description
comfort social dimension
Timepoint
24 hour after surgery and before the intervention and after the intervention in Six days.
Method of measurement
score of social Dimension of comfort questionnaire
5
Description
Respect others dimension
Timepoint
24 hour after surgery and before the intervention and after the intervention in Sixth day.
Method of measurement
score of Respect others dimension
6
Description
Assurance of human presence Dimension
Timepoint
24 hour after surgery and before the intervention and after the intervention in Six days.
Method of measurement
Assurance of human presence Dimension score
7
Description
Positive Communication and attitude Dimension
Timepoint
24 hour after surgery and before the intervention and after the intervention on Sixth days.
Method of measurement
Positive Communication and attitude Dimension score
8
Description
Knowledge and Professional skills dimension
Timepoint
24 houre after surgery and before the intervention and after the intervention in Six days.
Method of measurement
Knowledge and Professional skills dimension score
9
Description
Attention to others' experiences dimension
Timepoint
24 hour after surgery and before the intervention and after the intervention on sixth day.
Method of measurement
Attention to others' experiences dimension score
Intervention groups
1
Description
Intervention group: Interventions include modification of environmental lights, devices’ alarm and personnel sounds and reflexothrapy in reflective chest point under the thumb of the left foot and cardiac surgery care training through face-to-face education and pamphlets. Interventions will be implemented during six consecutive days at 17 o’clock.
Category
Rehabilitation
2
Description
Control group will receive only routine care. Pamphlets will be given to patients on sixth day in order to comply with the ethical principles.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kordkoy Amiralmoomenin Hospital
Full name of responsible person
Dr.GholamAli Riaahy
Street address
Amiralmoomenin Hospital, Jangal street, Kordkoy, Golestan Province
City
Kordkoy
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Birgand University of Medical Sciences
Full name of responsible person
Shahnaz Tabiee
Street address
Birgand University of Medical Sciences; Ayatollah Ghaffari street; Birjand; South Khorasan
City
Birgand
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,Birgand 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
Birgand University of Medical Sciences
Full name of responsible person
Fatemeh Sheikhy
Position
Master Student in Nursing
Other areas of specialty/work
Street address
Roshanna complex, Sina 9, Ebne Sina Street, Kordkoy, Golestan Province.
City
Kordkoy
Postal code
Phone
+1 734326445
Fax
Email
ilia.sheikhy1364@gmail.com; Fa.sheikhy@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birgand University Medical Science
Full name of responsible person
Shahnaz Tabiee
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Birgand University Medical Sciences, Ayatollah Ghaffari Street;,Birgand, South Khorasan-
City
Birgand
Postal code
Phone
+56 32381410
Fax
Email
shahnaztabiee@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birgand University Medical Science
Full name of responsible person
Fatemeh Sheikhy
Position
Master Student in Nursing
Other areas of specialty/work
Street address
Roshanna complex, Sina 9, Ebne Sina Street, Kordkoy, Golestan Province.