Effect of multimodal program on anxiety and hemodynamic status in Patients undergoing electrophysiologic interventions in Afshar hospital in Yazd, 2016
Purpose
The present study aims to determine the effect of The impact of educational package on level of anxiety and also on hemodynamic status in patients waiting for diagnostic and therapeutic electrophysiological interventions. Method: This clinical trial study conducted on patients awaiting for electrophysiological interventions admitted to Afshar educational-therapeutic center in Yazd consists of Inclusion criteria: The ability to communicate orally ;The ability to understand the Persian language; No history of previous catheterization. Exclusion criteria: Lack of awareness of time, place and identity. 50 Samples were selected through convenience method and were allocated by random block method into two matched group named intervention ( received usual care and educational package) and control ( received usual care only) groups. Data was collected using three parts questionnaire including personal/clinical data, hospital anxiety and depression scale (only anxiety Part) and hemodynamic chart through interview and records observation and measurement. Personal/clinical data was collected one day before electrophysiology intervention and anxiety levels and hemodynamic status data was collected in two-phases: 1 –phase one day before electrophysiology and 2-phase30 min before electrophysiology intervention. In Intervention group the patient Received package including educational pamphlet, Training videos of patient preparation ablation procedure and oral Description was presented in a meeting of 20 minutes. research assumptions were The impact of educational package effective on anxiety and hemodynamic measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021832634N1
Registration date:2017-05-28, 1396/03/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Maryam Dadmehr
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 3622 1047
Email address
m.dadmehr@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of multimodal program on anxiety and hemodynamic status in Patients undergoing electrophysiologic interventions in Afshar hospital in Yazd, 2016
Purpose
Public title
Study of the impact of educational package on anxiety and hemodynamic status in Patients undergoing electro physiologic interventions at Afshar hospital in Yazd, 2016 .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The ability to communicate orally; The ability to understand the persian language; No history of previous catheterization (According to the patient); Signed consent. Exclusion criteria: history of mental illness;taking Anti-anxiety drugs and sedatives; Lack of awareness of time, place and identity. loss Criteria: absence of Patients in the ablation; ablation cancellation.
Age
From 17 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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 Sciences and Health Services
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh
City
Yazd
Postal code
8916877443
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR.SSU.REC.1395.133
Health conditions studied
1
Description of health condition studied
Cardiac arrhythmia
ICD-10 code
I47, I48
ICD-10 code description
Paroxysmal tachycardia- Atrial fibrillation and flutter
Primary outcomes
1
Description
The average reduction in anxiety scores
Timepoint
Two phases: previous day of surgery and half an hour before procedure
Method of measurement
Interviews with hospital anxiety and depression questionnaire
Secondary outcomes
1
Description
The average reduction in hemodynamic indices
Timepoint
Two phases: previous day of surgery and half an hour before procedure
Method of measurement
Measure and record the work sheet values of hemodynamic parameters
Intervention groups
1
Description
In the intervention group, Patients received packages including educational pamphlet, film and oral description, in a 20-minute meeting in a room dedicated for this purpose. the researcher explained the goals of interventional electrophysiology diagnosis and treatment, preparation before and care after procedure, and the things that people will see, hear and probably feel.At the same session a film played for the purpose of patient preparation and correct position in bed after ablation. The questions and confusion of patients were answered. Previous day of surgery and half an hour before the procedure, anxiety and vital signs of patients controlled and recorded.
Category
Other
2
Description
In the control group patients received usual care and on the previous day of surgery and half an hour before the procedure, anxiety and vital signs of patients controlled and recorded.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Dadmehr Maryam
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh,
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Mehrparvar Hooshang
Street address
Bahonar square, Shahid Sadoughi University of Medical Sciences and Health Services,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services
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
Shahid Sadoughi University Medical Sciences Yazd, School of Nursing & Midwifery
Full name of responsible person
Dadmehr Maryam
Position
Critical Care Nursing Master Science Student
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
m.dadmehr@ssu.ac.ir maryamdadmehr1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences , School of Nursing & Midwifery
Full name of responsible person
Kalani Zohre
Position
Master of Science in Medical Surgical Nursing
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh
City
Yazd
Postal code
8919848968
Phone
+98 35 3824 1751
Fax
Email
kalani_z @yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dadmehr Maryam
Position
Critical Care Nursing Master Science Student
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh
City
Yazd
Postal code
8919848968
Phone
+98 35 3824 1751
Fax
Email
m.dadmehr@ssu.ac.ir maryamdadmehr1@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)