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Clinical trial on the influence of sound therapy on signs variations of hemodynamic orthopedic patients.

Protocol summary

Summary
The goal of this study is examining the Influence of sound therapy on variations of hemodynamic in orthopedic patients during general anesthesia. In the operation day, during and after the beginning of general anesthesia, the patients' hemodynamic signs(blood pressure, heart beat) in both groups are recorded. Population under study, all people refering to Jahrom Peymanie Hospital will undergo orthopedic surgery by general anesthesia if they lack in criteria excluding them from study. Sample of 72 is estimated prior to operation, patients are put into two groups by tossing a coin:1. Observer2.sound therapy intervention. In the first group, after entering the operation room, the patients' hemodynamic signs will be recorded right away. however, in the second one, patients's hemodynamic signs are recorded by using headphones and playing sound. The night before operation day, the patients are visited and their information is completed. After operation and entrance to recovery, their hemodynamic signs are recorded every 5 minutes and this procedure lasts for 20 minutes. All patients must have cautious written consent to be allowed to participate in the study. The patients suffering the chronic and cancer-related pains, hearing and speech impairment and the lack of mental emotional health will be excluded from the study. It is expected that the intervention results in a reduction in the hemodynamic signs variations and an increase in the satisfaction of using the non drug method of pain control.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051414049N5
Registration date: 2017-10-05, 1396/07/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Ali Abbasi Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1501
Email address
abbasija@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on the influence of sound therapy on signs variations of hemodynamic orthopedic patients.
Public title
the Influence of sound therapy on signs variations of hemodynamic in upper-body orthopedic patients during general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : All the patients who are to undergo anesthesia for upper body orthopedic operations in peymanie hospital connected with Jahrom medicine university.Cautious consent for participating in the study, is one of the main entrancecriteria.Exclusion criteria:Not interested in nature sounds, Those who are addict or has been using drugs and painkillers over a long time Those patients undergoing operation who need action or medications besides to routine care to get rid of side effects and pain relief.Unstable hemodynamic status, state results in chronic and cancer-related pains , Hearing or speech impairment, lack of mental emotional health and expressing disagreement for continuing the research.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study sampling process is carried out through tossing coin in order to divide them into two groups: Control group and Intervention group Double blind method has been used in this study so that the 1- The volunteer and 2- The person who records hemodynamic sign are not aware of measurement methods in intervention and control group. about the way people are put in intervention,control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Approval date
2018-07-05, 1397/04/14
Ethics committee reference number
IR.JUMS.REC.1396.027

Health conditions studied

1

Description of health condition studied
hemodynamic changes after sound therapy
ICD-10 code
Z01.8
ICD-10 code description
Other specified special examinations

Primary outcomes

1

Description
Hemodynamic variations
Timepoint
Every 5 minutes over 20 minutes during anesthesia
Method of measurement
Every 5 minutes over 20 minutes during anesthesia

Secondary outcomes

1

Description
Agitation
Timepoint
when exiting the anesthesia
Method of measurement
Richmond scale

Intervention groups

1

Description
Intervention group: intervention includes using headphone and playing sound. by using headphone, comforting sound of nature such as birds, river, waterfall sounds will be played for each patients and then their hemodynamic signs will be recorded.
Category
Treatment - Other

2

Description
In the Control group after entering the operation, Hemodynamic signs would be recorded without any further action..
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahrom Peymanie Hospital
Full name of responsible person
Hojati Hamed Seyed
Street address
Jahrom، Jahad Square، Peymanie Hospital
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Solh Ju Kavos
Street address
Vice chancellor for research, Jahrom University of Medical Sciences, Motahhari Blvd, Jahrom
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Hojati Hamed Seyed
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71 3834 3915
Fax
Email
hamedhojati94@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Abbasi Jahromi Ali
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71 5647 4254
Fax
Email
AbbasiJa@jums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Hojati Hamed Seyed
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
00
Fax
Email
hamedhojati94@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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