Comparing the impact of fentanyl- music therapy, fentanyl- midazolam and ketorolac-midazolam on pain and anxiety of patient undergoing Extracorporeal Shock Wave Lithotripsy
Objectives: determine the effect of fentanyl - midazolam on pain and anxiety of patients treated with ESWL; determine the effect of keterolac- midazolam on pain and anxiety of patients treated with ESWL; determine the effect of Fentanyl - music therapy on pain and anxiety of patients treated with ESWL; compare the effects of Fentanyl - music therapy, keterolac- midazolam and fentanyl - midazolam on pain and anxiety in patients treated with ESWL
Design: All patients with urinary stones between 18 and 60 years old referred for ESWL were enrolled to study. Randomization based on ABC blocks and sample size determine with pilot study (10 patients in each group) and patients were placed in groups A: Fentanyl music therapy, B: Keterolac- midazolam, C: Fentanyl- Midazolam.
In all three groups, prior to ESWL, anxiety measured by visual analog scale and hemodynamic parameters will be recorded. In Group A: 1μg / kg intravenous fentanyl will be injected and starts the music player with headphones. Group B: ketorolac 30 mg and midazolam 1mg; in Group C: Fentanyl μg / kg and Midazolam 1 mg will be injected and headphones off placed on the patient's head. In all cases, the pain will be measured by numerical rating scale every 10 minutes and after the lithotripsy procedure. Hemodynamic parameters will be recorded initially and then every 10 minutes and at the end of the procedure and anxiety will be recorded at the end of lithotripsy. If the patient was restless during lithotripsy any time or pain score was above 7, with the approval of anesthesiologist dose will be repeated and patient is excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511026776N2
Registration date:2015-12-24, 1394/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Tooba Hoseini Azizi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 58 3225 0358
Email address
hoseiniat881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
North Khorasan University of Medical Sciences
Expected recruitment start date
2015-12-20, 1394/09/29
Expected recruitment end date
2016-06-18, 1395/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the impact of fentanyl- music therapy, fentanyl- midazolam and ketorolac-midazolam on pain and anxiety of patient undergoing Extracorporeal Shock Wave Lithotripsy
Public title
impact of music therapy on anxiety and ketorolac on pain of patient undergoing Extracorporeal Shock Wave Lithotripsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: aged between 18 and 60 years ; literacy; undergoing lithotripsy; no history of lithotripsy
Exclusion criteria: Cancel to continue participating in the study; severe pain during lithotripsy is in need of medical intervention; Disrupted during lithotripsy for any reason
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
North Khorasan University of Medical Sciences
Street address
North Khorasan
City
Bojnourd
Postal code
Approval date
2015-10-05, 1394/07/13
Ethics committee reference number
ir.nkums.rec.1394.34
Health conditions studied
1
Description of health condition studied
urinary stones
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
pain
Timepoint
each 10 min during and after Procedure
Method of measurement
numeric pain rating scale
2
Description
anxiety
Timepoint
before and after procidure
Method of measurement
Anxiety numerical visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
music therapy - fentanyl 1μg / kg
Category
Treatment - Other
2
Description
ketorolac 30 mg - midazolam 1 mg
Category
Treatment - Drugs
3
Description
fentanyl 1μg / kg - midazolam 1mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital. ESWL center
Full name of responsible person
Street address
City
Bojnourd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Dr Alireza Golshan
Street address
Shahid Sohaghar ave. no 36
City
bojnourd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
North Khorasan 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
North Khorasan University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing, Shahyar Boulevard
City
Bojnourd
Postal code
Phone
+98 58 3225 0358
Fax
Email
hoseini.tooba@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
MSc
Other areas of specialty/work
Street address
Faculty of Nursing, Shahyar Boulevard
City
Bojnourd
Postal code
Phone
+98 58 3225 0358
Fax
Email
hoseini.tooba@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)