The purpose of this study is to determine the effect of self-selected calming music on pain intensity due to needle insertion into a fistula in hemodialysis patients. The research community in this study is patient treated with hemodialys by arteriovenous fistula in Fatemeh Zahra and Imam Khomeini hospital in sari, Iran. This study is a randomized clinical trial in which 114 patients of hemodialysis randomly allocated to 3 groups of music, headphone and control group.
Inclusion criteria: willing to listen to music; being 18 years or older; lack of neuropathic disorders; havingno known history of depression; being treated with hemodialysis for at least 3 months; not being administered analgesics and sedatives within 3 hours before needle insertion into a fistula; having no history of taking antipsychotic drugs; not being mentally impaired; having no visual and hearing dysfunction and not being habited to listen to music during hemodialysis.
Exclusion criteria: existence the acute pain in other area of body; need to try for needle insertion in to a fistula more than once; change in physical condition; refusing to continue study and death.
First the pain intensity due to venopuncture is measured in 3 group without any intervention after needle insertion in arteriovenous into a fistula. Then during the next session of hemodialysis in the music group; favorite song will be played 6 minutes before needle insertion into a fistula by headphone and mp4 player and In the headphone group, it will be used headphone without play music 6 minutes before needle insertion into a fistula and also in the control group, it will be done based on the ward’s routine. Then, in 3 group, pain degree due to needle insertion in to a fistula will be measured with visual analogue scale, one minute after the completion fixing needle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607297494N20
Registration date:2016-08-08, 1395/05/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-08, 1395/05/18
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-19, 1395/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-selected calming music on pain intensity due to needle insertion in to a fistula in hemodialysis patients.
Public title
The effect of self-selected calming music on pain intensity due to needle insertion in to a fistula in hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willing to listen to music; being 18 years or older; lack of neuropathic disorders; havingno known history of depression; being treated with hemodialysis for at least 3 months; not being administered analgesics and sedatives within 3 hours before needle insertion into a fistula; having no history of taking antipsychotic drugs; not being mentally impaired; having no visual and hearing dysfunction and not being habited to listen to music during hemodialysis.
Exclusion criteria: existence the acute pain in other area of body; need to try for needle insertion in to a fistula more than once; change in physical condition; refusing to continue study and death.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Science
Street address
Sart of valiye asr highway, Imam Square, Sari, Mazandaran
City
Sari
Postal code
4736131167
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.MAZUMS.REC.95.2435
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.9
ICD-10 code description
pain, unspecified
Primary outcomes
1
Description
pain
Timepoint
before and after intervention
Method of measurement
visual analoug scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention of group 1: First in intervention group with music, pain degree due to needle insertion into an arteriovenous fistula will be recorded with visual measure immediately after needle insertion without any intervention. In the next session of hemodialysis, favorite song of every patient will be played by using headphone and mp4 player 6 minutes before needle insertion in to a fistula until the end of venopuncture and participants will be asked to entirely focus on music. Then one minute after the completion of venopuncture and fixing a needle, pain intensity due to neddle insertion in to a fistula will be recorded by visual analogue scale.
Category
Other
2
Description
Other interventions
Intervention of group 2( headphone group): First in the intervention group with headphone during a session of hemodialysis, without any intervention, the pain degree due to needle insertion into a arteriovenous fistula will be recorded with visual measure immediately after needle insertion. In the next session of hemodialysis in this group, it will be used headphone without playing music 6 minutes before needle insertion into a fistula. Then, one minute after the completion venopuncture and fixing needle insertion, pain intensity due to needle insertion into a fistula will be measured with visual analogue scale.
Category
Other
3
Description
Control group: For control group based on ward’s routine, needle insertion in to a fistula will be done without any intervention. Then a minute after end of venopuncture and fixing needle, the pain degree due to needle insertion in to a fistula during 2 sessions of hemodialysis will be measured with visual analogue scale.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari, Emam Khomeini hospital and FatemehZahra hospital.
Full name of responsible person
DR Masoumeh Bagheri- Nesami
Street address
Sari, Emam Khomeini hospital and FatemehZahra hospital.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran.
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Science
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Position
Phd- faculty
Other areas of specialty/work
Street address
of Nursing & Midwifery Mazandaran University of Medical Sciences, Sari, Iran.
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
Ph.D- Faculty member
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical, Sciences, Sari, Iran
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
Email
anna3043@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)