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The effect of head up position on severity of shoulder pain during and after cesarean section under spinal anesthesia

Protocol summary

Study aim
Determining the effect of head-up position on shoulder pain during and after elective caesarean section surgery under spinal anesthesia Comparison of the intensity of shoulder pain in supine and head-up positions during elective caesarean section surgery under spinal anesthesia in: 1. During operation 2. During recovery 3. 12 hours after the operation 4. 24 hours after the operation 5. 48 hours after the operation
Design
Clinical trial with two control and intervention groups, with parallel groups, one blind strain, with gradual random sampling, without drug intervention on 116 patients. The rand function of Excel software was used for randomization.
Settings and conduct
the effect of the head-up position on the severity of shoulder pain during and after surgery in elective caesarean section patients at Shahidan Mobini Hospital in Sabzevar. After the birth of the baby until the end of the recovery period, the patient is placed in one of two control or intervention groups and without blinding
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elective Cesarean section with: Gestational age more than 36 weeks 18-45 years old Weight between 60-90 kg Exclusion criteria: History of seizures, Drug abuse, fracture or dislocation of shoulder joints and chronic pain in this area, chronic shoulder or upper limb pain, mental illness suffering from cardiovascular disease,blood pressure and Preeclampsia Contraindications for spinal anesthesia
Intervention groups
Head up position group (intervention): Placement in a 30 degree head up position, after the birth of the baby until the end of the recovery time. Supine group (control): Placement in supine position ,after the birth of the baby until the end of the recovery time
Main outcome variables
Shoulder pain, pain onset time, side of shoulder pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230816059160N1
Registration date: 2023-09-25, 1402/07/03
Registration timing: prospective

Last update: 2023-09-25, 1402/07/03
Update count: 0
Registration date
2023-09-25, 1402/07/03
Registrant information
Name
Zahra Izi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 7613
Email address
izizahraizi56@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of head up position on severity of shoulder pain during and after cesarean section under spinal anesthesia
Public title
Investigating the effect of position on the intensity of shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All elective caesarean section patients with a gestational age greater than 36 weeks All elective caesarean section patients aged 18-45 years All elective caesarean section patients weighing between 60-90 kg
Exclusion criteria:
History of seizures Drug abuse A history of fracture or dislocation of shoulder joints and chronic pain in this area History of chronic shoulder or upper limb pain Having a history of mental illness Suffering from cardiovascular disease Suffering from hypertension and preeclampsia Prohibition of spinal anesthesia
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 116
Randomization (investigator's opinion)
Randomized
Randomization description
This research is a probability sampling method. The samples are selected by gradual random sampling method after confirming that they meet the entry criteria and do not have the non-entry criteria. The samples are placed one by one in one of the test and control groups.
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 Sabzevar University of Medical Sciences
Street address
Tawheed Shahr Blvd., above the Tomb of Anonymous Martyrs, University Campus Building, Ethics Committee
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.MEDSAB.REC.1402.046

Health conditions studied

1

Description of health condition studied
Shoulder pain during and after cesarean section
ICD-10 code
O60-O75
ICD-10 code description
Complications of labour and delivery

Primary outcomes

1

Description
measuring of shoulder pain intensity with the Numeric Pain Rating Scale (NPRS)
Timepoint
During cesarean section, during recovery, 12, 24 and 48 hours after the operation
Method of measurement
The Numeric Pain Rating Scale (NPRS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In this group, the effect of position on shoulder pain in elective caesarean section patients under spinal anesthesia is investigated.After the birth of the baby until the end of the recovery, patients is placed in a 30 degree head-up position, and then the shoulder pain is measured from during the operation untill 48 hours after the operation in these times: during operation, during recovery, 12, 24 and 48 hours after operation.and then compared with the control group
Category
Treatment - Other

2

Description
Control group: In this group of patients, they do not receive any treatment intervention.The patients are placed in a supine position after the birth of the baby until the end of recovery, and then the shoulder pain is measured from during the operation untill 48 hours after the operation, in these times: during operation, during recovery, 12, 24 and 48 hours after operation, and then compared with the intervention group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahidan Mbini hospital
Full name of responsible person
Zahra Izi
Street address
North Kashfi Street, Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613856776
Phone
+98 51 4401 8473
Fax
+98 51 4422 1002
Email
Mobini.H@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Miri
Street address
Tawheed Shahr Blvd., above the tomb of anonymous martyrs, university campus building
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
M.S@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Izi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, unit 1, corner of Golestan St., Enghelab St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618683545
Phone
009844667613
Email
zahra.izi7063@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Izi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Unit 1,Golestan St., Enghelab St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618683545
Phone
+98 51 4466 7613
Email
zahra.izi7063@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Izi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, unit 1, corner of Golestan St., Enghelabl St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618683545
Phone
+98 51 4466 7613
Fax
Email
izizahraizi56@gmail.com

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
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