Comparison of the Effect of Invalid Music and Quranic Voices on Sleep Quality and Anxiety in Patients Admitted to Coronary Care Units (CCU)
Design
Clinical trial with control group, two intervention groups, parallel, one blind, randomized
Settings and conduct
The present study is a clinical trial that will be conducted in patients with acute coronary syndrome admitted to CCU department of Hajar hospital in Shahrekord.
After ensuring the inclusion criteria, Informed consent form, demographic information questionnaire, Spielberger Anxiety Inventory and Sleep Quality Questionnaire in St. Mary's Hospital will be completed after 24 hours after hospitalization.
Afterwards, the patients will be randomly assigned to three groups of Quran (32 students), speechless music (32) and control (32 people).
After at least 2 successive sessions by headphones, a questionnaire related to the quality of sleep and anxiety will be filled out by the Voice of the Ocean group, the Quran voice group and the control group at the student's level.
Participants/Inclusion and exclusion criteria
log in:
Completion of informed consent form
Being aged 18 to 65 years old
Not having a history of mental illness
Deaf hearing loss
Having a sleep disorder
Stability of vital signs
Non arrival:
Unwillingness to participate in the plan
Deafness
Disorders of consciousness
Having mental illnesses that lead to taking medication
Not having sleep disorder during the first 24 hours
Intervention groups
In the Qur'an, the patients will listen to the sound of the Qur'an using headphones. In the non-verbal musical group, patients will listen to the ocean by using headphones. In the control group, headphones will be used without sound.
Main outcome variables
Sleep quality, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190222042798N1
Registration date:2019-04-19, 1398/01/30
Registration timing:registered_while_recruiting
Last update:2019-04-19, 1398/01/30
Update count:0
Registration date
2019-04-19, 1398/01/30
Registrant information
Name
Masomeh Mohammadpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1497
Email address
st-mohammadpoor.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-14, 1397/12/23
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Instrumental Music and Quranic Voices on Sleep Quality and Anxiety in Patients Admitted to Coronary Care Units (CCU)
Public title
The Effect of Instrumental Music and Quranic Voices on Sleep Quality and Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Completion and signing the informed consent form
Aged between 18 and 65 and full vigilance
Not having a history of psychiatric illness leading to admission or taking neurological drugs and screening for psychiatric disorders
Loss of hearing
Sleep disturbance with the St. Mary's Sleep Quality Questionnaire is fully confirmed after 24 hours of admission and is greater than 11.
Stability of vital signs (blood pressure, pulse, respiration and temperature).
Exclusion criteria:
Unwillingness to participate in the study
Disorders of consciousness
Deafness
Having mental illnesses that lead to taking medication
Not having sleep disorder during the first 24 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, individuals are selected based on simple random sampling. The researcher then selects the research environment and selects all patients who have the criteria for entering the study. After selecting the samples, their random allocation In three groups, using the card method inside the envelope, there are 32 plain memorization cards and 32 cards of the Qur'an and 32 control cards inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
All of the participants in each of the three groups use headphones and are not aware that each of the headphones plays a different sound.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Shahr kurd University of Medical Sciences
Street address
Street of Shohadaye Sufeh
City
Esfahan
Province
Isfehan
Postal code
8174785754
Approval date
2019-03-14, 1397/12/23
Ethics committee reference number
IR.SKUMS.REC.1397.297
Health conditions studied
1
Description of health condition studied
Acute cronery syndrom
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality
Timepoint
24 hours after admission and the 4th day after admission
Method of measurement
Sleep quality questionnaire in St. Mary's Hospital
2
Description
Anxiety
Timepoint
24 hours after admission and day 4 after admission
Method of measurement
Spillberger's Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the Qur'anic voice group, the patients stayed for 20 minutes when the CCU lights were turned off in order to rest and sleep at night by using headphones to sound the Qur'an (verses 78 to the end of the Sura al-Asra) with the voice of Master Saadal-Ghamedi in the form of a trilate And in Nahavand style) will listen.
Category
Rehabilitation
2
Description
Intervention group: In the non-verbal musical group, patients will listen to the ocean sound using headphones for at least 20 minutes when they turn off the CCU lights for rest and night sleep.
Category
Rehabilitation
3
Description
Control group: In the control group, patients will use a non-sounding headset for at least 20 minutes when CCU lights are turned off for rest and night sleep.