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The effects of early mouth feeding on the amount of pain in elective cesarean patients

Protocol summary

Study aim
The effects of early feeding on the amount of pain in elective cesarean patients, admitted to Imam Khomaini hospital In Divandareh 1395
Design
This study will be performed on 126 patients under elective cesarean section having the qualification of entering this study, they will be divided into intervention and control groups. The pain will be measured based on the VAS instrument and recorded as the time of entering the department, 6,12,18, and 24 hours after surgery.
Settings and conduct
People studied in this research will include all Cesarean section patients admitted to the women ward in Imam Khomeini Hospital of Divandareh. After obtaining the consent of the university Ethics Committee and receiving an introduction letter from the university research assistant and getting the permission from the hospital and gynecology department of the Imam Khomeini Hospital, the researcher will attend at the morning shift of the hospital delivery department. She will study the Pregnant elective cesarean women files and will select the qualified ones. Then, the goals of the survey will be explained to the qualified patients and informed consent will be taken from them and data collection will begin. Sampling will be available and after selecting the samples randomly using closed envelopes, they will be in one of the two groups: control or start feeding early with the liquid diet.
Participants/Inclusion and exclusion criteria
Entry criteria includes singleton pregnant women, 38-42 weeks of pregnancy, elective Cesarean ( history of at least another previous cesarean). Exit criteria: Needing for blood transfusion for any cause, postoperative fever, post-partum anomalies diagnosis.
Intervention groups
Patients in the intervention group (early feeding with liquid diet) will be placed in sitting position 6 hours after surgery. Mouth feeding, Initially, 30 ml equals to half of a glass of tea and 4 cubes of dissolved sugar will be given to the mother. Then, in case of tolerance and lack of nausea and vomiting after an hour, this volume doubles and can drink 60 ml of the liquid. After this time, based on the dietary intake of the patients, patients will receive juice and yogurt in the form of a soup diet if they tolerate and do not have nausea and vomiting, so that the patient's minimum fluid intake will be 1500 ml for each person per 24 hours. After starting mouth feeding, the flow of the vein fluid will be stopped. Before starting feeding, the pain of the mothers will be measured and recorded. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire. Patients in the control group will be treated according to the routine care. Meaning they will lie down on the back position for 12 hours without eating or drinking anything. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire.
Main outcome variables
pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170110031865N3
Registration date: 2018-01-30, 1396/11/10
Registration timing: registered_while_recruiting

Last update: 2018-01-30, 1396/11/10
Update count: 0
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
Zahra Rashidei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 773 1082
Email address
zrashidei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-07-26, 1397/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of early mouth feeding on the amount of pain in elective cesarean patients
Public title
The Effect of early mouth feeding on the post-cesarean pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
women with singleton pregnancies gestational age 38 to 42 weeks elective cesarean (History: at least another previous Cesarean) surgery with a cross-section of the abdomen and spinal anesthesia vital signs within normal non-smoker and no addiction to drugs lack of any history of abdominal surgery other than caesarean Child alive Willing to participate in the study
Exclusion criteria:
patients giving up for any reason medical disorders and Midwifery (diabetes , anemia, high blood pressure, heart disease, cardiovascular, renal, pulmonary, gastrointestinal, thyroid, immune disorders, infectious, psychiatric, metabolic disorders, electrolyte and irritable bowel syndrome)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
When entering the department, research units will be placed in one of the control or intervention groups (early liquids) using a simple random method using closed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The sample patients will be chosen by using closed envelopes randomly, and they will be placed in either groups ( control or intervention with early liquid diet).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Pasdaran street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IR.MUK.REC.1395/354

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle

Primary outcomes

1

Description
Pain
Timepoint
Arrival, 6,12,18 and 24 hours after surgery.
Method of measurement
Visual Analoge Scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Patients in the intervention group (early feeding with liquid diet) will be placed in sitting position 6 hours after surgery. Mouth feeding, Initially, 30 ml equals to half of a glass of tea and 4 cubes of dissolved sugar will be given to the mother. Then, in case of tolerance and lack of nausea and vomiting after an hour, this volume doubles and can drink 60 ml of the liquid. After this time, based on the dietary intake of the patients, patients will receive juice and yogurt in the form of a soup diet if they tolerate and do not have nausea and vomiting, so that the patient's minimum fluid intake will be 1500 ml for each person per 24 hours.(If the nausea and vomiting of the patient are in an extent that they are not eager to eat and the fluids are less than 200 ml in 4 hours, the infusion of fluids continues and the person leaves the study). After starting mouth feeding, the flow of the vein fluid will be stopped. Before starting feeding, the pain of the mothers will be measured and recorded. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire.
Category
Other

2

Description
Control group: Patients in the control group will be treated according to the routine care. Meaning they will lie down on the back position for 12 hours without eating or drinking anything. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Zahra Rashidei
Street address
Imam Khomeini street
City
Divvandareh
Province
Kurdistan
Postal code
6641967397
Email
zrashidei@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences
Full name of responsible person
Farzin Rezaee
Street address
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
sanandaj
Province
Kurdistan
Postal code
6641967397
Phone
+98 87 3872 0241
Email
zrashidei@yahoo.com
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 and technology of Kurdistan 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

2

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ronak Shahoei
Street address
Imam khomaini street.Imam khomaini hospital
City
Divvandareh
Province
Kurdistan
Postal code
6641967397
Phone
+98 87 3872 0241
Fax
+98 87 3872 0241
Email
zrashidei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Kurdistan University of medical sciences
Full name of responsible person
zahra rashidei
Position
Nurse/MS.C
Latest degree
Bachelor
Other areas of specialty/work
Street address
Imam khomaini street
City
Divvandareh
Province
Kurdistan
Postal code
6641967397
Phone
+98 87 3872 2930
Fax
Email
zrashidei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of medical sciences
Full name of responsible person
Ronak Shahoei
Position
Assistant professor.Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87317464
Fax
Email
zrashidei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Ronak Shahoei
Position
ph.D/Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177 -13446
Phone
+98 87
Fax
Email
zrashidei@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main consequence of the study is shared.
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
Use results in related studies
From where data/document is obtainable
E-mail address, contact number
What processes are involved for a request to access data/document
A maximum of one month from the first e-mail
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