the effect of music on pain and agitation after septorhinoplasty
Design
a clinical trial with a control group, that patients have been classified as study or control by block randomization
Settings and conduct
this study will be conducted in Amir-almomenin hospital, Rasht. Patients, surgeon(before intervention), data collector and analyzer are unaware of groupings, codes are in an enclosed envelope in operation room and intervention-er has access just initiating the intervention.
Participants/Inclusion and exclusion criteria
patients 18-65 years old candidate for septorhinoplasty in amir-almomenin hospital are entered. known cases of mood disorder,known cases of hearing or cognitive problems, history of drug or alcohol abuse, history of antidepressant or tranquilizers usage, complex septorhinoplasty which requires specific techniques like harvesting conchal or costal cartilage and prolonged operation time are excluded
Intervention groups
music will be played in study group in earphones, control group will hear silence
Main outcome variables
pain , agitation after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210307050609N2
Registration date:2022-04-11, 1401/01/22
Registration timing:registered_while_recruiting
Last update:2022-04-11, 1401/01/22
Update count:0
Registration date
2022-04-11, 1401/01/22
Registrant information
Name
Sevil Nasirmohtaram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 8307
Email address
sevil198@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of playing music during surgery on postoperative pain and agitation in patients undergoing septorhinoplasty: a clinical trial
Public title
The effect of music on pain and agitation after septorhinoplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
candidates of septorhinoplasty
Exclusion criteria:
known cases of mood disorder
known cases of hearing or cognitive problems
history of drug or alcohol abuse
history of antidepressant or tranquilizers usage
complex septorhinoplasty which requires specific techniques like harvesting conchal or costal cartilage and prolonged operation time
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be performed in 25 blocks of four, via sealed envelope software in www.sealedenvelope.com. A unique randomization code will be devoted to each randomization number group, the codes are recorded in questionnaires. the interventioner will play file 1 or 2 of playlist based on the matched code list in operating room, while unaware of playlist.
Blinding (investigator's opinion)
Double blinded
Blinding description
At the time of history taking , a coded checklist will be put in patients records. Decoding is inaccessible for everyone except for intervention-er. the intervention-er who is in operation room is not in touch with patient and wont see the code before entrance of patient to operation theater. All the checklists are gathered by residents who are unaware of codes and grouping. List of codes are kept in an envelope in a locked case in operation room, lock is kept by secretory. The surgeon, surgical technician, and patients are unaware of groups before beginning of intervention. Surgical technician, anesthesiologist and anesthesiology technician are unaware of music played in earphones. During induction the resident will play playlist 1 (music) or 2(silence), based on the code. surgical aid circular will record operation time, pulse rate and mean arterial pressure. Anesthesiologist colleague will record agitation-sedation score. Patient satisfaction will be recorded in ward by a resident.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gilan University of medical sciences
Street address
Amir-almomenin hospital, 17 shahrivar Ave.
City
Rasht
Province
Guilan
Postal code
4165755199
Approval date
2022-02-04, 1400/11/15
Ethics committee reference number
IR.GUMS.REC.1400.538
Health conditions studied
1
Description of health condition studied
pain and agitation after surgery
ICD-10 code
F-41
ICD-10 code description
other anxiety disorders
Primary outcomes
1
Description
agitation after surgery
Timepoint
evaluation of agitation during extubation and in recovery ward
Method of measurement
with sedation-agitation score
2
Description
pain after surgery
Timepoint
in recovery ward
Method of measurement
with visual analogue scale
Secondary outcomes
1
Description
patient satisfaction of operation process
Timepoint
once in ward
Method of measurement
checklist based on patient's declaire
Intervention groups
1
Description
Intervention group: music played via earphone during surgery. In study group instrumental music (piano played by master Javad Maroofi, with a mean rhythm of 80 bytes per minute and with a intensity of 50-65 dB) will be played from induction phase till the end of the operation.
Category
Treatment - Other
2
Description
Control group: silence played via earphones during surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-almomenin hospital
Full name of responsible person
Sevil Nasirmohtaram
Street address
No.17 , 108 Ave.,Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 912 386 5953
Email
sevil198@ yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirmohtaram
Street address
No.17 , 108 Ave.,Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 912 386 5953
Email
sevil198@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirmohtaram
Position
assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.17 , 108 Ave.,Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3211 9653
Email
sevil198@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirohtaram
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 17, 108 Ave., Golsar Blvd.
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3211 9653
Email
sevil198@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirmohtaram
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 17, 108 Ave., Golsar Blvd.
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3211 9653
Email
sevil198@ 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
all data can be shared after omitting personal information
When the data will become available and for how long
after submitting the article
To whom data/document is available
researchers in academic fields
Under which criteria data/document could be used
just as a reference for their own studies
From where data/document is obtainable
email to cor-responder
What processes are involved for a request to access data/document
sending an email, receiving the data after evaluating the request