Comparison of the effect of thought distraction by music therapy and the presence of patient accompaniment on anxiety level of patients undergoing endoscopy
Music Therapy and the presence of patient accompaniment on level of anxiety
Design
A double-blind clinical trial consist of 105 samples with the range of age 15 to 55 years old, including control group and two groups, random allocation.
Settings and conduct
The endoscopy study site is Shahid Mohammadi and Khalige Fars hospitals in Bandar Abbas. The patients will be randomly assigned according to the random number table to three group. Each patient will receive one special code, so the patients will be blinded for the intervention they will receive. On the other hand the statistical specialist who will analyze the data, won't be aware about patients allocation and intervention (double blind).
Participants/Inclusion and exclusion criteria
inclusion criteria:Age of 55-15 years; Ability to understand Persian language;consciousness;Hearing Health;No history of endoscopy
Non-inclusion criteria: Recognized and treated psychological problems; Pre-endoscopic drug use; Pre-endoscopic sedative and anxiolytic drugs; Emergency endoscopy
Intervention groups
intervention group 1 (music therapy): these patients will receive the nature sound, through a headphone during endoscopy
intervention group 2 (Endoscopy with accompanying presence): escort the patient during the endoscopy
Control group: these patients only receive the routine care for the operation
Main outcome variables
anxiety ;music therapy;presence of patient accompaniment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190715044215N1
Registration date:2020-01-06, 1398/10/16
Registration timing:retrospective
Last update:2020-01-06, 1398/10/16
Update count:0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Afsaneh Alaei Sheikh Robat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 0755
Email address
afsaneh_alaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2019-08-16, 1398/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of thought distraction by music therapy and the presence of patient accompaniment on anxiety level of patients undergoing endoscopy
Public title
Effect of music therapy and the presence of patient accompaniment on anxiety level during endoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
15-55 years of age
Ability to speak and understand Persian language
Full conscious and healthy hearing and visual ability
No history of gastrointestinal endoscopy
Exclusion criteria:
History of known and under treatment psychological problems
taking drug before endoscopy
Taking sedation and anxiolytics drugs before endoscopy
Emergency endoscopy
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
We randomly chose participants using random numbers table through random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals according to the table will be included in the study and each group and members of each group will be assigned a specific code and assigned according to the table into three groups, because this is done so that we can blind patients and patients from The type of interventions is not known to other patients (a single blind), and the other is a statistician blind who will analyze the data without knowing the groups studied (the other side blindness).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
No 2, Sarmad Building, N0.11 Resalat alley ,Daroopakhsh street
City
Bandar Abbas
Province
Hormozgan
Postal code
7915866764
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.HUMS.REC.1397.322
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
anxiety
Timepoint
Before and after intervention
Method of measurement
Spill Burger Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (Music therapy group) ; these patients receive natural sounds (river, rain, tree leaves, birds) through a headphone during the endoscopy
Category
Prevention
2
Description
Intervention group 2: (Accompanying group); accompanying the patient (a relative or friend) or any patient who wishes to accompany the patient during the endoscopic procedure.
Category
Prevention
3
Description
Control group: (No intervention); these patients receive only routine care before endoscopy.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalij Fars hospital
Full name of responsible person
Afsaneh Alaei Sheikh Robat
Street address
No 2, Sarmad Building, N0.11 Resalat alley ,Daroopakhsh street
City
Bandar Abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3366 6226
Email
Afsaneh_alaei@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Afsane Alaei Sheikh Robat
Street address
Shahid Mohammadi Hospital, Jomhori Eslami Blvd, Bandar Abba, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Email
shmh@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teimoor Agha Molaei
Street address
No. 6 , Banafshe Ave., Islamic Republic Blvd., Bandar Abaas Town
City
Bandar Abaas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3366 6367
Email
research@hums.ac.ir
Web page address
http://mail.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afsaneh Alaei Sheikh Robat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 2, Sarmad Building, N0.11 Resalat alley ,Daroopakhsh street
City
Bandar Abbas
Province
Hormozgan
Postal code
7915866764
Phone
+98 76 3366 6226
Email
afsaneh_alaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Aref Faghih
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Nursing and Midwifery, Southern Resalat, Resalat Street, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7915866764
Phone
+98 76 3366 7904
Email
a.faghih@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Afsaneh Alaei Shiekh Robat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 2, Sarmad Building, N0.11 Resalat alley ,Daroopakhsh street
City
Bandar Abbas
Province
Hormozgan
Postal code
7915866764
Phone
+98 76 3366 6226
Email
afsaneh_alaei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main outcome
When the data will become available and for how long
10 months after publishing the article.
To whom data/document is available
Academic Institutions
Under which criteria data/document could be used
By mentioning the source and for doing research
From where data/document is obtainable
Afsaneh Alaei Shiekh Robat
What processes are involved for a request to access data/document