Clinical trials of checking the effect of music therapy during cesarean section on serum β endorphin, Vital Sign and postoperative pain on pregnant women
The aim of this study is to find a nonpharmacological or behavioral method for pain relief which leads to a progress in recovery specially after a cesarean section that needs rapid contact of mother and baby. In this intervention clinical trial research which doesnt contain a placebo, patients undergoing a cesarean section at Al Zahra Hospital who meet the inclusion criteria, are randomly studied. Sampling in this research is systematic and the number of subjects, based on previous similar studies and sample size formula, is 41 patients in each group. Sample assignment to music therapy group and non music therapy control is based on the table of random numbers; which is classified in phase 2 of researches. Before beginning of the study in maternity ward, the intervention procedure is defined for patients, informed consent form of the research is filled by them. Inclusion criteria includes: cesarean section on primipara women with obstetrics and gynecology indication. In the event of any complications, if the patient is not interested in music or withdraws, the sample is eliminated from the study. For music therapy, an MP3 player and a headphone set is used which plays light instrumental or religious music. The music is is played from the first moment of beginning of operations and takes 30 minutes. Then its effect on serum β endorphin, Vital Signs and postoperative pain will be studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041216325N5
Registration date:2017-07-28, 1396/05/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-28, 1396/05/06
Registrant information
Name
Katayoun Haryalchi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
haryalchi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of checking the effect of music therapy during cesarean section on serum β endorphin, Vital Sign and postoperative pain on pregnant women
Public title
The effect of music therapy on pain of cesarean section
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1. Cesarean section on primipara women
2. Obstetrics and gynecology indications for cesarean section
3. Spinal anesthesia
Exclusion criteria:
1. History of laparotomy
2. Physical and mental illnesses
3. Chronic pains
4. Occurrence of any complications during operations and anesthesia
5. In the event that patients are not interested in the music
6. If the patients ask for stopping music therapy during the operation
7. Patients' withdraw
Age
From 20 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling in this research is systematic and the number of subjects, based on previous similar studies and sample size formula, is 41 patients in each group. Sample assignment to music therapy group and non music therapy control is based on the table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Gaz squre
City
Rasht
Postal code
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
IR.GUMS.REC.1395.362
Health conditions studied
1
Description of health condition studied
Single spontaneous delivery
ICD-10 code
O82
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
β endorphin
Timepoint
Before and after operation
Method of measurement
ELISA kit
Secondary outcomes
1
Description
The pain
Timepoint
Immediately after the operation; 1 hour after the operation; 6 hours after the operation; 12 hours after the operation; 24 hours after the operation
Method of measurement
NRS scale
2
Description
Vital signs
Timepoint
Before the operation; immediately after the operation; 1 hour after the operation; 6 hours after the operation; 12 hours after the operation; 24 hours after the operation
Method of measurement
Heart rate per minute, blood pressure per millimeter Hg, respiratory rate in one minute, via manometer and pulse oximeter
3
Description
Used opioid
Timepoint
During the operation; immediately after the operation; 1 hour after the operation; 6 hours after the operation; 12 hours after the operation; 24 hours after the operation
Method of measurement
The amount of opoid drugs used for relieving pain in cc
Intervention groups
1
Description
In order to do music therapy we use a pair of headphones and an MP3 player which plays which plays light instrumental music from standard tracks, accepted by Psychiatric Association, or religious music. Playing music start at the beginning of operation and lasts for 30 minutes.
Category
Treatment - Other
2
Description
Non music therapy control group do not get any music therapy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Reproductive health research center, Al Zahra hospital
Full name of responsible person
Dr. Katayoon Haryalchi
Street address
Namju street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Guilan University of Medical sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Gaz Squre
City
Rasht
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 of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Samere Rasuli
Position
Bachelor student of surgical technology
Other areas of specialty/work
Street address
Misagh 4 alley, Sardare Jangal street
City
Rostam Abad
Postal code
4464155343
Phone
+98 13 3467 1009
Fax
Email
Samereh.rasoli928@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Katayoon Haryalchi
Position
Anesthesia specialist
Other areas of specialty/work
Street address
Al Zahra hospital, Namjoo streat
City
Rasht
Postal code
4144654839
Phone
+98 13 3336 9124
Fax
Email
K-haryalchi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Arezoo Arya
Position
Anesthesia student
Other areas of specialty/work
Street address
Number 7, Flihi 1 alley, Takhti street
City
Rasht
Postal code
4173753165
Phone
+98 13 3323 4137
Fax
Email
ArezooArya0@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)