The purpose of this study is to determine the effect of the Tavvasol Praying on anxiety and physiological parameters in patients with myocardial infarction admitted to coronary care unit at Ayatullah Rouhani hospital, Babol, Iran. Inclusion criteria: age older than 40 years, Muslim and Shiite, lack of history of anxiety and psychiatric disorders, lack of hearing problems, hospitalization for the first time in the Cardiac Care Unit. Exclusion criteria: taking a sedative medication during the study, going under cardiopulmonary resuscitation during the study and have a dysrhythmia during the study.
This study is a single blinded clinical trial (blinding will be done for the information analysts). Data will be collected in two groups of intervention and control on 80 patients in random blocks. Data will be gathered by Demographic Questionnaire, Hospital Anxiety questionnaire and physiological parameters sheet.
The intervention consists of Playing the audio file of the Tavvasol Praying via headphone for the intervention group, 6 hours after admission to CCU and 24 hours later. Control group will receive routine care. Anxiety and physiological indicators for the prayer therapy group 6 hours after entering the department and immediately after Playing Prayer and in the control group 6 hours after arrival to CCU and immediately after the same time as playing the file for intervention group will be measured. This process is repeated 24 hours after admission to CCU in both two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071818550N5
Registration date:2017-08-15, 1396/05/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Semnan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of Tavvasol Praying on anxiety and physiologic parameters in patients with myocardial infarction admitted to Coronary Care Unit
Public title
Tavvasol Praying for anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age over 40; Muslim and Shiite; lack of history of anxiety and psychiatric disorders; lack of hearing problems; hospitalization for paradise in cardiac care unit
Exclusion criteria: Taking a sedative during the study; under the cardio-pulmonary resuscitation of the CCU during the study and heart dysrhythmias during the study
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Bolevard, Semnan, Iran
City
Semnan
Postal code
3513138111
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.SEMUMS.REC.1396.88
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
In 4 times: 6 hours after hospitalization in CCU, immediately after intervention for first time and 24 hours after first time intervention and immediately after intervention for second time
Method of measurement
Hospital Anxiety questionnaire
Secondary outcomes
1
Description
Blood Pressure
Timepoint
In 4 times: 6 hours after hospitalization in CCU, immediately after intervention for first time and 24 hours after first time intervention and immediately after intervention for second time
Method of measurement
Digital Spyghmomanometer
2
Description
Heart Rate
Timepoint
In 4 times: 6 hours after hospitalization in CCU, immediately after intervention for first time and 24 hours after first time intervention and immediately after intervention for second time
Method of measurement
Digital manometer
3
Description
O2 Saturation
Timepoint
In 4 times: 6 hours after hospitalization in CCU, immediately after intervention for first time and 24 hours after first time intervention and immediately after intervention for second time
Method of measurement
Digital Pulse Oximeter
4
Description
Body Temperature
Timepoint
In 4 times: 6 hours after hospitalization in CCU, immediately after intervention for first time and 24 hours after first time intervention and immediately after intervention for second time
Method of measurement
Digital Tympanic Membrane termometer
5
Description
Respiration Rate
Timepoint
In 4 times: 6 hours after hospitalization in CCU, immediately after intervention for first time and 24 hours after first time intervention and immediately after intervention for second time
Method of measurement
Digital manometer
Intervention groups
1
Description
Intervention1: Playing the audio file of the Tavvasol Praying via headphones, at 6 hour after admission to CCU and 24 hours after first time playing.
Category
Other
2
Description
Intervention 2: Control group recieve routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital of Babol
Full name of responsible person
Ayatollah Rouhani Hospital, University Square, Keshavarz Street, Babol
Street address
Rahmat Shafie Pour Sadati
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Semnan University of Medical Sciences
Full name of responsible person
Professor Ali Rashidy pour
Street address
Vice chancellor for research and technology, Semnan University of Medical Sciences,.Basij Bolevard, Semnan, Iran
City
Semnan
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 and technology, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
PhD. Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
Email
nr_dana@semums.ac.ir; nr_dana@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
Email
nr_dana@semums.ac.ir; nr_dana@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
PhD. Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
Email
nr_dana@semums.ac.ir; nr_dana@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)