Protocol summary

Summary
This study is a blind clinical trial will be done on 72 patients (cannot able to communicate and report pain) who admitted to intensive care unit of Tehran University of Medical Sciences Hospitals. If the patients have all inclusion criteria, after obtaining consent from their families, will be enrolled in the study. The patients randomly allocated into two groups, intervention and control. Ten minutes before the intervention, the pain will be measured and recorded by using CPOT, vital signs (systolic pressure, diastolic pressure, mean arterial pressure and pulse rate) and arterial blood oxygen saturation with checking the monitoring system, in the groups. The intervention group will listen to selected music using MP3 player with headphones for 30 minutes for three days. Thirty minutes after the intervention, the vital signs and pain will be assessed. Moreover, during the intervention, arterial blood oxygen saturation and vital signs will be assessed every 10 minutes in both of groups. In the control group will not be done any intervention during the 30 minutes and they only must be rest during this periods. The primary outcomes of the study will be vital signs, oxygen saturation and behavioral pain score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105301599N11
Registration date: 2011-07-24, 1390/05/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Mitra Zolfaghari
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
zolfaghm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Nursing and Midwifery Care Research Center.
Expected recruitment start date
2011-08-01, 1390/05/10
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of favorite music on physiological and behavioral parameters of pain in unconscious patients admitted to Intensive care unit
Public title
The effect of music on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 50 years old; Hospitalized in ICU for the first time; Inability to verbally report pain; Existence of pain in patients by CPOT; Lack of hearing problems; Quadriplegia exclusion criteria: Increasing the dose of sedative and anesthetic drugs during the study; Neuromuscular blocking; Brain dead; Reluctance to cooperating the patient's family
Age
From 18 years old to 50 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
CENTER OF NURSING AND MIDWIFERY RESEARCH
Street address
CENTER OF NURSING AND MIDWIFERY RESEARCH, TEHRAN UNIVERSITY OF MEDICAL SCEINCES FACUITY OF NURSING AND MIDWIFERY, SQUARE OF THOHID, TEHRAN
City
TEHRAN
Postal code
Approval date
2011-07-15, 1390/04/24
Ethics committee reference number
*****

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52.9
ICD-10 code description
Generalized pain NOS

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Ten minutes before the intervention, each 10 minutes during the intervention (three times), 30 minutes after intervention
Method of measurement
observation of Monitoring

2

Description
behavioral parameters of pain
Timepoint
10 minutes before intervention 30 minutes after intervention
Method of measurement
Measurement by critical pain observation tool(CPOT)

3

Description
Systolic blood pressure
Timepoint
Ten minutes before the intervention, each 10 minutes during the intervention (three times), 30 minutes after intervention
Method of measurement
observation of Monitoring

4

Description
Mean arterial pressure
Timepoint
Ten minutes before the intervention, each 10 minutes during the intervention (three times), 30 minutes after intervention
Method of measurement
observation of Monitoring

5

Description
Pulse
Timepoint
Ten minutes before the intervention, each 10 minutes during the intervention (three times), 30 minutes after intervention
Method of measurement
observation of Monitoring

6

Description
Arterial oxygen saturation(sao2)
Timepoint
Ten minutes before the intervention, each 10 minutes during the intervention (three times), 30 minutes after intervention
Method of measurement
observation of Monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Resting in bed for 30 minutes without any intervention
Category
N/A

2

Description
Listening to music with headphones. Intervention time during three consecutive days for 30 minutes at PM 3-4:30
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

3

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nursing and Midwifery Care Research Center,Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Street address
Nursing and Midwifery Care Research Cente, Tehran University of Medical Sciences, FACUITY OF NURSING AND MIDWIFERY, EAST NOSRAT ST, SQUARE OF THOHID, THERAN, IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing and Midwifery Care Research Center,Tehran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Position
PhD
Other areas of specialty/work
Street address
Nursing and Midwifery Care Research Cente, FACUITY OF NURSING AND MIDWIFERY, TEHRAN UNIVERSITY OF MEDICAL SCEINCES, EAST NOSRAT ST, THOHID SQ, TEHRAN, IRAN
City
Tehran
Postal code
Phone
+98 66937120
Fax
Email
Zolfaghm@tums.ac.ir
Web page address

Person responsible for updating data

Contact

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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