The effect of acupressure on anxiety before cesarean section and pain, nausea and vomiting after cesarean section in women admitted to Vali Asr Hospital in 1396
Design
In this study, 60 patients undergoing cesarean section surgery were selected randomly. Participants were randomly assigned to two groups of control and intervention and each participant was given a code.
Settings and conduct
The present study is a randomized, single blind randomized clinical trial. This study is done at Valiasr Hospital in Fasa, Iran. The individual in the placebo group will not be aware of the ineffectiveness of the acupressure point. Acupressure points used in the pre-surgery Yintang and HE-7 points. Also, the points used after surgery are the ST-36 and the LI-4 point.
Participants/Inclusion and exclusion criteria
Inclusion criteria: have no skin problems at the point of acupressure, no use of sedative and stimulant drugs such as alcohol, no use of anti-nausea medicines after surgery. Exclusion criteria: spinal anesthesia
Intervention groups
The groups in this study are divided into two groups of 30 person. The intervention group receive acupressure at the HE-7 and Yinteng Point. The control group also receive acupressure at an ineffective point.
Main outcome variables
Anxiety is evaluated before surgery and after the surgery, the pain and nausea and vomiting of the patients are evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036784N3
Registration date:2018-01-29, 1396/11/09
Registration timing:retrospective
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 669 4977
Email address
fo.abadi@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-12-13, 1396/09/22
Actual recruitment end date
2018-01-25, 1396/11/05
Trial completion date
empty
Scientific title
The effect of acupressure on anxiety before cesarean section and nausea, vomiting and pain after cesarean section in woman admitted to hospital
Public title
Effect of acupressure on anxiety, nausea, vomiting and pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian nationality
Having no specific problem at the site of acupressure (no wounds, burns, cysts, abscess)
No use of sedatives, analgesics or anxiety drugs before surgery.
Being alert before surgery.
No an emergency condition before surgery.
No history of mental illness.
No history of using acupressure before surgery
No history of drug or alcohol addiction.
Not having physical problems (vision, hearing, mental)
No previous history of nausea and vomiting after surgery
No receive analgesic and anti-nausea medicine after surgery.
Having an age range of 18 to 45 years
Use of general anesthesia during surgery
Exclusion criteria:
The patient's unwillingness to continue cooperation in research
Cancellation of the patient's cesarean section during the study or occurrence of any problem during the study (chest pain and shortness of breath)
Using anti-nausea and vomiting drugs after surgery
Spinal anesthesia
History of liver disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method consists of 4-part blocks. In each block, two person are in the control group and two in the intervention group. Before surgery and during sampling, the samples are matched in two groups of control and intervention in terms of age before thirty years, after thirty years and history of Cesarean section.
Blinding (investigator's opinion)
Single blinded
Blinding description
Before surgery, the control group receive an acupressure at an inaccurate point. The control group do not know about the point being ineffective.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Valiasr Hospital, Ebn Sina Square
City
Fasa
Province
Fars
Postal code
8668874616
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.FUMS.REC.1396.276
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
3
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Reduce anxiety
Timepoint
One hour before transfer to the operating room, and immediately after the intervention.
Method of measurement
Spielberger's Standard Spell Checker Questionnaire (measurement of anxiety will be low to high).
2
Description
Reduce pain
Timepoint
The first turn of the acupressure is one hour after the surgery and the second intervention is also three hours after the first intervention.
Method of measurement
Visual Analogue Scale
3
Description
Reduce nausea and vomiting
Timepoint
The first turn of the acupressure is one hour after the surgery and the second intervention is also three hours after the first intervention.The intervention period will be ten minutes at two st-36, li-4 points.
Method of measurement
A questionnaire for assessing nausea and vomiting is a Rhodes index.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before surgery, they receive acupressure in two points, Yintang and HE-7, at the same time for five minutes. After surgery, st-36 and li-4 acupressure for ten minutes.
Category
Treatment - Other
2
Description
Control group: Before surgery, the control group receive acupressure for five minutes at Ineffective point. After surgery, the control group will not receive acupressure at any point.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr hospital
Full name of responsible person
Faezeh Abadi
Street address
Valiasr Hospital, Ebn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
faeze.abadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Faezeh Abadi
Street address
Ebn Sina Square, Fasa University Of Medical Science
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
faeze.abadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Faezeh Abadi
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebn Sina Square, Fasa University Of Medical Science
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
faeze.abadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Faezeh Abadi
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebn Sina Square, Fasa University Of Medical Science
City
Fasa
Province
Fars
Postal code
3345688976
Phone
+98 913 669 4977
Email
faeze.abadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Faezeh Abadi
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebn Sina Square, Fasa University Of Medical Science
City
Fasa
Province
Fars
Postal code
3345688976
Phone
+98 71 5335 0994
Email
faeze.abadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Only the original outcome information can be released.
When the data will become available and for how long
Starting the access period from 1399
To whom data/document is available
Study data will be available to academic researchers.
Under which criteria data/document could be used
Only if the source of data usage is mentioned is allowed.
From where data/document is obtainable
Email us at: faeze.abadi@yahoo.com
What processes are involved for a request to access data/document
After sending the email to the address, the author tries to provide the applicant with the required information within a maximum period of one month if requested.