Protocol summary

Study aim
To evaluate the comparative effect of eye mask and music on anxiety level and primary hemodynamic parameters of patients undergoing coronary angiography (CAG).
Design
Single blind an experimental comparative design, 157 participants undergoing coronary angiography in single center, randomly assigned in to four groups (three experimental groups and one control)
Settings and conduct
Cardiac Catheterization and Surgery Center, Al-Diwaniyah, Iraq. The single blind method was assured as patients were not aware that listening to music, wearing eye mask, or both.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients were eligible if they were aged above 18 years (male and female), scheduled and admitted for elective CAG, not having visual and hearing impairments, not administered narcotics, sedatives, and antipsychotics before CAG. Exclusion Criteria: If participant having a history of previous CAG, admitted for urgent CAG, and those who are refused to engage in the study. Furthermore, the withdrawal exclusion criteria were refused to continue participating in the study, headphone or eye mask removed during procedure, and total CAG period more than 20 min or less than 10 min.
Intervention groups
1. Music group, participants listening to music during CAG procedure. 2. eye mask group, participants wearing eye mask during CAG procedure. 3. eye mask- music group, participants listening to music and wearing eye mask in same time during CAG.
Main outcome variables
1.Anxiety level pre-test and post-test. 2. primary hemodynamic parameters at three measures.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240411061467N1
Registration date: 2024-05-09, 1403/02/20
Registration timing: registered_while_recruiting

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Hussam Al-Zourphi
Name of organization / entity
Baghdad University/ Collage of Nursing
Country
Iraq
Phone
+964 781 199 4351
Email address
hossam.nahu2202m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-05, 1403/02/16
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eye Mask and Music on The Level of Anxiety and Primary Hemodynamic Parameters in Patients Undergoing Cardiac Angiography: A Randomized Controlled Trail
Public title
The Effect of Eye Mask and Music on The Level of Anxiety and Primary Hemodynamic Parameters in Patients Undergoing Cardiac Angiography
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients were eligible if they were aged above 18 years (male and female), scheduled and admitted for elective coronary angiography (CAG). Not having visual and hearing impairments. Not administered narcotics, sedatives, and antipsychotics before CAG.
Exclusion criteria:
Patients who cannot read or write, suffering from acute pain, having a history of previous CAG. Admitted for urgent CAG. Refuse to engage in the study. Refused to continue participating in the study, headphone or eye mask removed during procedure, total CAG period more than 20 min or less than 10 min.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
Sample size
Target sample size: 157
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used in assigning participants (individuals: people undergoing elective CAG) to music, eye mask, eye mask-music and control groups. The randomization procedure involved choosing a number from a sealed envelope that contained two numbers: One and two (1 was in the control group and 2 was in the intervention group). Then, in order to allocate the patients in music, eye mask, and eye mask-music groups, another sealed envelope that contains three numbers (1 was in music, 2 was in eye mask, and 3 was in eye mask-music) was given to the patients who were allocated in the intervention group in the previous step.
Blinding (investigator's opinion)
Single blinded
Blinding description
The single blind method was assured as patients were not aware that listening to music, wearing eye mask, or both in the same time, in order to prevent possible biases.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of College of Nursing / University of Baghdad
Street address
No. 3, Bab Al-Moadham Bridge Street, Bab Al- Moadham hay, Baghdad city, Iraq.
City
Baghdad
Postal code
992M+CV4
Approval date
2024-02-25, 1402/12/06
Ethics committee reference number
4401

Health conditions studied

1

Description of health condition studied
Coronary angiography- induce anxiety.
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Decrease level of anxiety and control of primary hemodynamic parameters within normal range.
Timepoint
Anxiety level and measured immediately before intervention and 20 min after. primary hemodynamic measured immediately before, 10min during, and 20min after intervention.
Method of measurement
State- trait anxiety inventory score to measure anxiety level and sphygmomonometer and pulse oximeter to measure primary hemodynamic parameters.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Music group (Listening to music).
Category
Treatment - Devices

2

Description
Intervention group 2: Eye mask group (wear an eye mask).
Category
Treatment - Devices

3

Description
Intervention group 3: Eye mask-music group (wear an eye mask and listening to music at the same time)
Category
Treatment - Devices

4

Description
Control group: Received daily care only.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiac catheterization and surgery center
Full name of responsible person
Hamead Hassan
Street address
NO. 12, Ignorant Soldier Street, Saray hay, Al-Diwaniya city, Iraq
City
Al-Diwaniya cite
Postal code
XWHH+685
Phone
+964 775 330 0870
Email
www.diwa_health@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Collage of Nursing/ University of Baghdad
Full name of responsible person
Prof. Dr. Wissam Jabbar Qassem
Street address
NO. 6, alsaadoun Street, Al-saadoun hay, Baghdad city, Iraq
City
Baghdad city
Postal code
8c89+GVP
Phone
+964 770 889 5643
Email
dr.wissamjk@conursing.uobaghdad.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Collage of Nursing/ University of Baghdad
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
Collage of Nursing/ University of Baghdad
Full name of responsible person
Hussam Alwan Jaber
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Academic nurse in cardiac care unite.
Street address
No. 6, Al-Sabtain School Street, Al-Sadder town, Al-Diwaniya, Iraq.
City
AL-Diwaniya
Province
Al- Sadder town
Postal code
RXG3+3C7
Phone
+964 781 199 4351
Email
hossam.nahu2202m@conursing.uobaghdad.edu.iq

Person responsible for scientific inquiries

Contact
Name of organization / entity
Collage of Nursing/ University of Baghdad
Full name of responsible person
Sabah Abbas Ahmed
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Adult Nurse Department
Street address
No. 59, Mashatal street, AL-Wazeria, Baghdad, Iraq.
City
Baghdad
Province
Al- Rusafa side
Postal code
99CG+8JM
Phone
+964 771 234 0519
Email
dr.sabah@conursing.uobaghdad.edu.iq

Person responsible for updating data

Contact
Name of organization / entity
Diwaniyah Health Department/ Diwaniya Teaching Hospital
Full name of responsible person
Hussam Alwan Jaber
Position
academic nurse
Latest degree
Bachelor
Other areas of specialty/work
Academic nurse in cardiac care unite.
Street address
No. 6, Al Sabtain School Street, Al-Sadeer, Al- Diwaniya city, Iraq.
City
Al-Diwania
Province
Al-Sadeer town
Postal code
RXG3+485
Phone
+964 781 199 4351
Email
hossam.nahu2202m@conursing.uobaghdad.edu.iq

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All sociodemographic data of participants
When the data will become available and for how long
The data will be available after the article is published in a scientific journal early next year (2025)
To whom data/document is available
The data will be available to students, academic professors, as well as health institutions.
Under which criteria data/document could be used
SPSS will be used to analyze data descriptively and inferentially. Thus, the results are used after completing the statistical analysis.
From where data/document is obtainable
Data will be collected at the Specialized Cardiac Catheterization and Surgery Center in Al-Diwaniyah Governorate, Iraq. Director of the Center, Dr. Hamid Hassan Al-Moussawi. phone number: 009647753300870
What processes are involved for a request to access data/document
Data will be collected from patients undergoing elective coronary angiography via a questionnaire, which includes demographic data and an anxiety scale, which will be filled out by the participant, while primary hemodynamic parameters will be measured and recorded by the researcher.
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