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Protocol summary
- Study aim
The effect of sound therapy in women under cesarean section with spinal anesthesia on neonates Apgar score in Motahhari Hospital in 2019
- Design
This is a double-blind randomized study. The study group consisted of 92 women referred to Jahrom Motahhari Hospital who underwent cesarean section. Individuals are divided into intervention and control groups by throwing dice.
- Settings and conduct
This study will be carried out at Jahrom university in 2020. On the surgery day, the case will be asked to listen to the sound of nature playing through headphones for 20 minutes until her infant will be born. After the infant's birth, at the minutes 1, 5, 10, 15, 20 the Apgar score will be recorded by a researcher who will be unaware of the control and intervention groups.
- Participants/Inclusion and exclusion criteria
Patient Satisfaction to Participate in the Study;All patients undergoing cesarean section at Motahari Hospital of Jahrom University of Medical Sciences;Spinal anesthesia for the mother approved by the anesthesiologist; Term pregnancy; Non-emergency surgery;Individuals in need of any non-routine medication (like painkillers) or treatment during surgery (before birth); instability of hemodynamic state; ptient dissatisfaction to remain in research; If any sign of meconium aspiration is observed by diagnosis of the specialist, the case will be removed from the study .
- Intervention groups
On surgery day, calming nature audios including the sounds of the forest, rain, river waterfall, etc. will be played through a Marshal headphone model Major and the Sony MP3 player model NWZ-B183F with the sound ratio of 25-50 decibel. After the infant is born a trained researcher, who is unaware of the allocation of patients to control or intervention group, will record the Apgar score at the minutes 1, 5, 10, 15 and 20.
- Main outcome variables
Apgar score in infants 1،5،10،15،20 minutes after birth
General information
- Reason for update
- Acronym
- IRCT registration information
IRCT registration number:IRCT20130718014049N9
Registration date:2020-03-03, 1398/12/13
Registration timing:prospective
Last update:2020-03-03, 1398/12/13
Update count:0
- Registration date
- 2020-03-03, 1398/12/13
- Registrant information
Name
Ali Abbasi Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1501
Email address
abbasija@jums.ac.ir
- Recruitment status
- Recruitment complete
- Funding source
- Expected recruitment start date
- 2020-03-29, 1399/01/10
- Expected recruitment end date
- 2020-06-30, 1399/04/10
- Actual recruitment start date
empty
- Actual recruitment end date
empty
- Trial completion date
empty
- Scientific title
- The effect of sound therapy in women under cesarean section with spinal anesthesia on neonates Apgar score in Motahhari Hospital in 2019
- Public title
- The effect of sound therapy in women under cesarean section with spinal anesthesia on neonates apgar score
- Purpose
- Supportive
- Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction to participate in the studyAll patients undergoing cesarean section at Motahari hospital of Jahrom University of Medical Sciences.Spinal anesthesia for the mother has been permitted by the anesthesiologist.Term pregnancyNon-emergency surgery
Exclusion criteria:
Individuals in need of any non-routine medication (like painkillers) or treatment during the surgery (before birth) instability of hemodynamic stateDissatisfaction of patient to participate in the researchIf any sign of meconium aspiration is observed by diagnosis of the specialist, the case will be removed from the study
- Age
- From 18 years old to 35 years old
- Gender
- Female
- Phase
- N/A
- Groups that have been masked
- Participant
- Investigator
- Outcome assessor
- Sample size
Target sample size:92
- Randomization (investigator's opinion)
- Randomized
- Randomization description
Patients are simply randomly divided into two groups of intervention and control if they meet the inclusion criteria and consent to participate in the study. In this case, once a dice is thrown for each patient, the patient with will be in the even number will be in intervention group, and patient with odd number will be in the control group.
- Blinding (investigator's opinion)
- Double blinded
- Blinding description
The neonatal Apgar Scale measure assessor will not be aware of the intervention or control groups.
- Placebo
- Not used
- Assignment
- Parallel
- Other design features
Secondary Ids
empty
Ethics committees
1
- Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
Ethic committee, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
Jahrom
Postal code
4619974148
- Approval date
- 2020-02-25, 1398/12/06
- Ethics committee reference number
- IR.JUMS.REC.1398.095
Health conditions studied
1
- Description of health condition studied
- Apgar score scale after sound therapy
- ICD-10 code
- ICD-10 code description
Primary outcomes
1
- Description
- Apgar score
- Timepoint
- Apgar score in infants1،5،10،15،20 minutes after birth
- Method of measurement
- Based on Apgar Scale
Secondary outcomes
empty
Intervention groups
1
- Description
- Intervention group:On surgery day, calming nature audios including the sounds of the forest, rain, river waterfall, etc. will be played through a Marshal headphone model Major and the Sony MP3 player model NWZ-B183F with the sound ratio of 25-50 decibel. After the infant is born a trained researcher, who is unaware of the identity of the control and intervention groups of mothers and infants, will record the Apgar score at the minutes 1, 5, 10, 15 and 20.
- Category
- Treatment - Devices
2
- Description
- Control group:In the control group routine spinal anesthesia will be performed and no action will be taken until the infants is born, then the infant's apgar will be recorded at 1, 5, 10, 15, 20 minutes.
- Category
- N/A
Recruitment centers
1
- Recruitment center
Name of recruitment center
Martyr Motaharie hospital
Full name of responsible person
Saman Siasi
Street address
Master Motaharie Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
74157-13597
Phone
+98 71 5433 3001
Email
sobhansaman9871@gmail.com
Sponsors / Funding sources
1
- Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavoos Solh joo
Street address
Research deputy, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
sobhansaman9871@gmail.com
- Grant name
- Grant code / Reference number
- Is the source of funding the same sponsor organization/entity?
- Yes
- Title of funding source
- Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Ali Abasi Jahromi
Position
Faculty
Other areas of specialty/work
Anesthesiology
Street address
Research deputy, Jahrom University of Medical science, martyr Motaharie Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
aliabbasijahromi@yahoo.com
Person responsible for scientific inquiries
- Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Ali Abasi Jahromi
Position
Science Committee
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Research deputy, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
aliabbasijahromi@yahoo.com
Person responsible for updating data
- Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Saman Siasi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Research deputy, Jahrom University of medical science, martyr Motaharie Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0406
Email
sobhansaman9871@gmailc.om
Sharing plan
- Deidentified Individual Participant Data Set (IPD)
- No - There is not a plan to make this available
- Justification/reason for indecision/not sharing IPD
There is no further information
- Study Protocol
- Yes - There is a plan to make this available
- Statistical Analysis Plan
- Yes - There is a plan to make this available
- Informed Consent Form
- No - There is not a plan to make this available
- Clinical Study Report
- Yes - There is a plan to make this available
- Analytic Code
- No - There is not a plan to make this available
- Data Dictionary
- No - There is not a plan to make this available
- Title and more details about the data/document
IPD collected for the primary outcome measure only
- When the data will become available and for how long
Six months after printing results
- To whom data/document is available
Only available for people working in academic institutions
- Under which criteria data/document could be used
Only scientific and practical use is allowed
- From where data/document is obtainable
Jahrom university of medical sciences
- What processes are involved for a request to access data/document
Apply to university and receive information
- Comments
