determinating the effect of auriculotherapy and music therapy on the pain after orthopedic surgery
Design
The clinical trial had a control group, one-way blind, randomized and 30 people participated in each group
Settings and conduct
The place of study is the surgery,s ward of Ali ibn Abitaleb Hospital in Rafsanjan city.
Individuals are randomly divided into groups and receive the desired care
Participants/Inclusion and exclusion criteria
Inclusion criteria: Orthopedic surgery, ear's health for auriculotherapy and music therapy
Exclusion criteria:Foreigners
Intervention groups
Samples in all of the three groups are studied from 6 hours after the orthopedic surgery to 24 hours later.
In the music therapy group, intervention takes place for 20 minutes twice 6 and 30 hours after the orthopedic surgery. In auriclotherapy group, the ear seeds are attached for 24 hours. In control group, the researcher is present at the patient's bedside for 20 minutes twice 6 and 30 hours after the surgery without any intervention.
The pain is measured by VAS just before and 20 minutes after each intervention for all three groups.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N21
Registration date:2021-10-18, 1400/07/26
Registration timing:retrospective
Last update:2021-10-18, 1400/07/26
Update count:0
Registration date
2021-10-18, 1400/07/26
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effects of music therapy and auriculotherapy on the pain of postoperative Orthopedic surgery
Public title
Comparing the effects of music therapy and auriculotherapy on the pain of postoperative orthopedic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elective surgery - orthopedic surgery (foot surgery, hand surgery, etc.)
Ear,s health for music therapy and auriculotherapy
Exclusion criteria:
Foreigners
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
By Simple randomization method and through lottery , it is determined which intervention should be used in each session
Blinding (investigator's opinion)
Single blinded
Blinding description
the person evaluating the pain is blind to the intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Imam َAli Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.RUMS.REC.1397.235
Health conditions studied
1
Description of health condition studied
Pain in patients undergoing orthopedic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Before intervention - Immediately after intervention - 24 hours after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:music therapy is done for 20 minutes twice ; six hours and thirty hours after orthopedic surgery.
Category
Rehabilitation
2
Description
Intervention group 2: Earrings will be installed in the ears for 24 hours 6 hours and 30 hours after orthopedic surgery.
Category
Rehabilitation
3
Description
En Intervention group3:In conrol group, researcher is present at the patient,s bed doing nothing for 20 minutes, twice: 6 hours and 30 hours after orthopedic surgery
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan Ali-ibn Abi-Talib Hospital
Full name of responsible person
Dr. Majid Kazemi
Street address
Parastar street
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
dr.kazemi.n@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3422 8324
Email
dr.kazemi.n@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 5900
Fax
Email
dr.kazemi.n@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 5900
Fax
Email
dr.kazemi.n@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3425 5900
Fax
Email
dr.kazemi.n@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available