Protocol summary

Study aim
Comparing the effect of eye mask and self selected music on the level of anxiety and hemodynamic indices in patients undergoing cardiac angiography
Design
Clinical trial with control group with parallel, double blind, randomized, and blocked; 360 patients in total, and 90 patients in each group, inclusive of loss.
Settings and conduct
Location: Fatemeh Zahra Hospital, Sari Hospital, Shahid Lavasani Hospital, Tehran. Anxiety assessment with a questionnaire, 10 min before the intervention and 20 min after the end of intervention, by an external evaluator and recording vital signs immediately before intervention, as soon as they were placed on the angiographic bed and 5 min after the intervention and immediately after Completion of the doctor's work and 20 min after the intervention by the researcher in all four groups. Doubles: An evaluator and statistician.
Participants/Inclusion and exclusion criteria
Entry: 18 years and older, patient conscious , candid for coronary artery angiography, Score higher than 32 after responding to anxiety inventory, willingness to participate in the study, physician's permission Music playback, No drug consuming for four hours and soothing at least one hour before the intervention, non-use of antipsychotics, lack of cognitive impairment, and lack of significant visual and auditory problems. Exit: Pregnancy, Acute pain, Illiterate patients and low levels of illiteracy, angiography history, Earn 73 anxiety score, Emergency Angiography,Medical personnel.
Intervention groups
Group A:Putting eyes mask on the patient's eyes. Group B:Play the desired music through the headphones for the patient. Group C:Putting eyes on the patient's eyes and music playback through headphones at the same time, .Group D:without any intervention.
Main outcome variables
Social-Demographic Information Questionnaire; Clinical Questionnaire; Spielberger Anxiety Inventory.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190328043132N1
Registration date: 2019-04-23, 1398/02/03
Registration timing: retrospective

Last update: 2019-04-23, 1398/02/03
Update count: 0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
sanaz esfandiary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8916
Email address
hjafari@mazums.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2018-12-21, 1397/09/30
Actual recruitment end date
2019-03-10, 1397/12/19
Trial completion date
2019-03-10, 1397/12/19
Scientific title
Comparing the effect of eye mask and self selected music on the level of anxietyand hemodynamic indices in patients undergoing cardiac angiography
Public title
Comparing the effect of eye mask and self selected music on the level of anxietyand hemodynamic indices in patients undergoing cardiac angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above. Patient is alert and able to verbal communication and eye contact, Candidate for coronary artery angiography, Earning score above 32 after responding to the Spielberger state-trait anxiety inventory, willingness to participate in the study, Desire to hear music, Allow physician to play music,Tendency to close the eye. No drug consuming for four hours and soothing at least one hour before the intervention, Non-use of antipsychotics, Lack of cognitive impairment,  The absence of significant visual and auditory problems
Exclusion criteria:
Pregnancy. The presence of acute pain in the part of the body,  Uneducated and very low literacy patients, Patients with angiography history,  Get an anxiety score of 73 up, Emergency Angiography , Medical personnel.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 360
Actual sample size reached: 360
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected by random method and will be randomly divided into four groups.Group A (eye mask ),Group B (self selected music) Group C (Receiver of self Selected Music and eye mask at the same time) And group D (control group).The design of this research is in the form of parallel groups, In this case, a comparison is made between the two randomly assigned groups.One group faces certain treatment and the other group is not faced.Participants in the study period remain in the examined and control groups.The necessity of the third group in this study (Receiver of self Selected Music and eye mask at the same time) is based on a clinical trial with factorial designs.So that they compare the two therapies simultaneously with the control group, and the third group will receive both treatments to examine the interference effects of the two treatments.The random allocation of patients in each of the four groups is performed using random block and all random variables are used to create the block.The random allocation of patients in each of the four groups is performed using random block and all random variables are used to create the block. Each block is assigned a number from 1 to 24 and These numbers are placed in the pieces of the cases for selection, and according to the sample size, N times randomly selected a nut, and again the vertebrae is returned to the lottery cycle to complete the number of members of the groups To make.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study is as follows: An assessment that completes the anxiety questionnaire before and after the intervention, and the statistician who studies the results is unaware of the process of doing the research (blinded) This knowledge, while the researcher is aware of the type of intervention devoted to the participants in the research, does not affect the analysis of the data.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Nasibeh Nursing College, Vesal street,Amir Mazandarani Blv
City
sari
Province
Mazandaran
Postal code
4816715793
Approval date
2018-12-11, 1397/09/20
Ethics committee reference number
IR.MAZUMS.REC.1397.3096

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The percent of people who have a Spielberger anxiety scores above 32.
Timepoint
Anxiety levels 10 minutes before intervention and 20 minutes after intervention.
Method of measurement
Spielberger State Trait Anxiety Inventory

Secondary outcomes

1

Description
Hemodynamic indices(blood pressure, hear rate, respiratory rate)
Timepoint
Immediately before, immediately after placement on the angiographic bed and 5 minutes after the intervention and immediately after the doctor completes the work, and 20 minutes after the end of the intervention
Method of measurement
Poyandegan Rah Saadat monitor digital and cuff pressure meter to it.

Intervention groups

1

Description
Intervention group: A(eye mask)
Category
Other

2

Description
Intervention group: B( self selected music)
Category
Other

3

Description
Intervention group: C( eye mask and self selected music at the same time)
Category
Other

4

Description
Control group: whit out intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra hospital
Full name of responsible person
Samad Golshani
Street address
Next to the Blood Transfusion Organization, Army Blvd,Imam Hossein Square.
City
sari
Province
Mazandaran
Postal code
4818813371
Phone
+98 11 3333 4001
Email
h.center.library@gmail.com

2

Recruitment center
Name of recruitment center
SHaheed Lavasany Hospital
Full name of responsible person
Syed Ali Jamalian
Street address
first of Abale Road,the end of the Shahid Hemmat (Zainuddin) highway,Sorkhe Hesar
City
Tehran
Province
Tehran
Postal code
1740003114
Phone
+98 21 7700 3021
Email
lavasani_tehran.hos@tamin.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
central headquarters of Mazandaran University of Medical Sciences and Health Services,the beginning of Valiasr highway,
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
nur-midnasibeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Jafary Hedayat
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Faculty of Nursing and Midwifery,Vesal Street,Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
Email
hjafari@mazums.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sanaz Esfandiary
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nassibe Faculty of Nursing and Midwifery, Vesal Street, Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8916
Fax
Email
esfandiary_sanaz69@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Bizhan Shabankhani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Central Headquarters of Mazandaran University of Medical Sciences and Health Services,Beginning of Vali-e-Asr Highway
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
shabankhani@yahoo.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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