The Effect of Spiritual Care on Pain Anxiety and Pain in Open Heart Surgery Patients.
Design
80 patients are considered open heart surgery.Non Randomly, 40 were in the spiritual care group and 40 in the control group. Spiritual care for the intervention group begins after surgery and is removed from the ventilator, after full awakening, and continues until the first chest tube is removed. The research assistant does not know the patient grouping, and Patients are asked to rate their pain severity in three stages (before, immediately and 10 minutes after chest tube removal) based on the Visual Analogue Scale (pain). Half an hour before the chest tube is removed, visual analogue scale (anxiety) is used.
Settings and conduct
Following the necessary arrangements, the study sample will be selected from the Afshar open heart surgery patients who have the inclusion criteria، one day before the cardiac surgery The research sample is selected . The method and purpose of the research are explained.They were non randomly assigned to intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with open heart surgery who have at least one chest tube .The patient should be alert and alert.The patient should not be under ventilator.Minimum age 20 years and maximum 75 years..Exclusion criteria: Patients with severe hearing impairment. Have a history of cognitive and mental problems.
Intervention groups
In the intervention group, one day before open heart surgery, the spiritual care program is tailored to patients' needs and desires, including the presence of support, support for the patient's religious rituals, and use of support systems. The control group performs routine care.
Main outcome variables
pain،Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200106046025N1
Registration date:2020-01-17, 1398/10/27
Registration timing:prospective
Last update:2020-01-17, 1398/10/27
Update count:0
Registration date
2020-01-17, 1398/10/27
Registrant information
Name
Hossin Fasihizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 6513
Email address
h.fasihizadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-18, 1398/10/28
Expected recruitment end date
2020-02-17, 1398/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of spiritual care On Chest Tube Removal Anxiety And pain In Patients Open Heart Surgery
Public title
spiritual care On Chest Tube Removal Anxiety And pain Open Heart Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Open heart surgery patients with at least one chest tube
The patient should be alert and awake and not having a ventilator device.
The patient is willing to participate in the study.
Minimum age of 20 years and maximum of 75 years
Exclusion criteria:
Patients with a history of cognitive and mental problems
Patients with severe hearing impairment
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregivers and outcome assessors and data analysts do not know the control and test patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Scinces Shahid Sadhoghi
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.SSU.REC.1398.161
Health conditions studied
1
Description of health condition studied
Coronary heart bypass
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass graft and biological heart valve graft
Primary outcomes
1
Description
pain
Timepoint
before, during and 10 minutes after removal chest tube
Method of measurement
Visual Analogue Scale (pain)
2
Description
Anxiety
Timepoint
before removal chest tube
Method of measurement
Visual Analogue Scale (Anxiety)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In order to provide spiritual care for the intervention group after the patient is fully awake and awake after surgery, the researcher introduces himself to the patient, and with the expression of professional abilities, tries to gain the patient's trust because of the patient's participation in care delivery and acceptance. How they care is one of the essential pillars of spiritual care. chest tube removal is performed by a researcher, and female patients by a trained female nurse. Patients who have two or three tubes are considered the first tube to be removed. Patient anxiety was measured by a research assistant (who was unaware of patient grouping), half an hour before removal chest tube, with the Visual Analogue Scale (Anxiety). The patient's pain was measured before, immediately and ten minutes after the chest tube was removed, using a visual analogue scale (pain).
Category
Treatment - Other
2
Description
Control group: The usual care is to remove the chest tube.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Hossin Fasihizadeh
Street address
Jomhuri Blvd, Afshar Hospital
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3522 7772
Email
h.fasihizadeh@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.M.Mirezaee
Street address
Research Council of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
h.fasihizadeh@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
ph.D of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing, St Bou Ali, Boulevard Brigadier Fallahi,yazd,iran
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Email
nasiriani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
ph.D of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing, St Bou Ali, Boulevard Brigadier Fallahi,yazd,iran
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1755
Email
nasiriani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hossin Fasihizadeh
Position
Student Nurse in master of critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jomhuri Blvd, Afshar Hospital
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3522 7772
Email
h.fasihizadeh@ssu.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