Comparison of the effect of acupressure at LI4 point and gum chewing on reactivation of gastrointestinal system after cesarean section: A Parallel Randomized Clinical Trial
Determining the effect of acupressure at LI4 point and gum chewing on the reactivation of the gastrointestinal system after cesarean section
Design
Clinical trial on 105 patients candidates for caesarean section with a control group, double-blind and randomized in a block of 6
Settings and conduct
This study is conducted on patients who are candidates for elective cesarean surgery in Bahar Shahroud Hospital. Acupressure techniques or gum chewing will be done 3 times a day for 20 minutes each time, until the gas is expelled for the first time after cesarean section. Then first-time gas passing after cesarean and the time of defecation for the first time after cesarean will be recorded by an evaluation that is blinded to the type of interventions and groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elective caesarean section with spinal anesthesia,
Healthy condition of the teeth for chewing gum,
Not having any lesions in the acupressure area.
Exclusion criteria: Lack of consciousness of the patient after the operation,
Any type of postoperative complication (patients with more than 1000 ml of postpartum bleeding),
Having diarrhea, chronic constipation, gastric reflux and irritable bowel syndrome according to the patient's statement
Intervention groups
In the gum chewing group, after the operation, a pack of gum is provided to the patients and they are asked to chew a piece of gum 3 times a day for at least 20 minutes. In the acupressure group, after the operation, acupressure will be applied 3 times a day for 20 minutes. In the control group, routine measures such as advice on fluid and fiber intake will be performed.
Main outcome variables
First time gas passing after cesarean,
The time of defecation for the first time after cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200206046395N3
Registration date:2024-01-21, 1402/11/01
Registration timing:prospective
Last update:2024-01-21, 1402/11/01
Update count:0
Registration date
2024-01-21, 1402/11/01
Registrant information
Name
Mobin Mottahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 8090
Email address
mobinmottahedi1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acupressure at LI4 point and gum chewing on reactivation of gastrointestinal system after cesarean section: A Parallel Randomized Clinical Trial
Public title
Comparison of the effect of acupressure at LI4 point and gum chewing on reactivation of gastrointestinal system after cesarean section:
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elective caesarean section with spinal anesthesia
Healthy condition of the teeth for chewing gum
Not having any lesions in the acupressure area
Ability to read and write in Persian
Being in the 38th to 42nd week of pregnancy
Age 18 to 35 years
Exclusion criteria:
Lack of consciousness of the patient after the operation
Change in anesthesia method (conversion to general anesthesia)
Injury to the intestine and bladder during surgery
Any type of postoperative complication (patients with more than 1000 ml of postpartum bleeding)
Drug and alcohol addiction according to the patient's statements
Having diarrhea, chronic constipation, gastric reflux and irritable bowel syndrome according to the patient's statement
Having language, hearing or vision disorders
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
In the beginning, all the modes in which 3 letters A, B and C can be put together in a block of 6 are produced and a block is selected randomly and by placing among the blocks.The layout pattern in that block is used to allocate patients
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the study, it is not possible to blind the study participants. However, measures were taken in collecting information. After the intervention, the person collecting the information will not know the type of the participants' group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrood University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.SHMU.REC.1402.169
Health conditions studied
1
Description of health condition studied
Postoperative Gastrointestinal Tract Dysfunction
ICD-10 code
K55-K64
ICD-10 code description
Other diseases of intestines
Primary outcomes
1
Description
First time gas passing after cesarean
Timepoint
3 times a day, every 8 hours
Method of measurement
Ask the patient
2
Description
The time of defecation for the first time after cesarean section
Timepoint
3 times a day, every 8 hours
Method of measurement
Ask the patient
Secondary outcomes
1
Description
The level of pain at the surgical site
Timepoint
3 times a day, every 8 hours
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Severe nausea and vomiting
Timepoint
3 times a day, every 8 hours
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Number of times vomiting
Timepoint
3 times a day, every 8 hours
Method of measurement
Ask the patient
4
Description
Duration of hospitalization
Timepoint
Until the end of discharge from the hospital
Method of measurement
Documents recorded in the patient's file
5
Description
Time to start moving the patient for the first time after cesarean section
Timepoint
3 times a day, every 8 hours
Method of measurement
Ask the patient
Intervention groups
1
Description
Intervention group: In the chewing gum group, a pack of Van brand gum (manufactured by Kurdistan Turpentine Company) containing xylitol is provided to the patients. They are asked to chew a piece of gum for at least 20 minutes 3 times a day before eating breakfast, lunch and dinner.
Category
Treatment - Other
2
Description
Intervention group: After the operation and after transferring the patients to the ward, acupressure will be performed 3 times a day for 20 minutes.In the acupressure group, the researcher will first wash his hands and warm the hands by touching them, he will ask the patient to be in the desired position, then by finding the LI4 point, he will massage the acupressure slowly and gently. It will be applied for 30 seconds. Gradually this pressure will increase until the patient feels tingling, numbness, heaviness and stretching around the area for 30 seconds. Then it is kept in the same position for 1 minute and gradually after that the pressure will be reduced for 30 seconds. Finally, 30 seconds will be held in the same position and 2 minutes of rest will be applied. Each cycle of this process will last 5 minutes, a total of four alternating 5-minute cycles for both hands will last about 20 minutes.
Category
Treatment - Other
3
Description
Control group: In the control group, routine measures such as recommendations for: 1- liquid consumption, 2- fiber consumption, 3- performing active and passive movements in bed will be performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
Hossein Bagheri
Street address
Bahar Hospital, in front of the Children's Park, 22 Bahman St, Shahroud
City
Shahroud
Province
Semnan
Postal code
3615739111
Phone
+98 910 038 8406
Email
mobinmottahedi1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamiyan
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 911 458 2145
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3233 8457
Email
mobinmottahedi1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahrood
Province
Semnan
Postal code
3614773955
Phone
+98 23 6548 7520
Email
mobinmottahedi1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahrood
Province
Semnan
Postal code
3614773955
Phone
+98 23 3233 5648
Email
mobinmottahedi1372@gmail.com
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
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
Yes - There is 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
Only part of the data, such as information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
If necessary, by contacting Mobin Mottahedi and if there is a logical justification for using it for scientific purposes
From where data/document is obtainable
Mobin Mottahedi, Shahrood, Haft Tir Square, Shahrood University of Medical Sciences; Faculty of paramedicine
What processes are involved for a request to access data/document
During a phone call or via e-mail and registering the request and stating the reason and purpose, which is logical and approved, up to two weeks