Protocol summary

Study aim
Comparison of the effect of acupressure in compression points LI4 and SP6 on severity of post-cesarean pain in women referred to Rafsanjan niche nursing home in 1396
Design
In this study, 90 women who are referred to the Rafsanjan Nifr-e Nafs Hospital for elective cesarean section and who have criteria for entering the study will be selected. Participants will be randomly divided into three groups of SP6 intervention or LI4 interventions based on pre-test and pre-test scores. Or control group will be divided so that the classes will be based on the grade of pain 4-6 in one class and the pain of 7-10 in the other category.
Settings and conduct
At the first time, complete recovery of the sensitivity and sensation of the lower limbs and before receiving the first dose of pain, the severity of pain will be measured by the Visual Analog Scale (VAS) scale. Samples will be divided into three groups based on pre-test pain severity. Then, in an intervention group at the SP6 point and in the intervention group at the point of LI4, the two-way pressures for 10 seconds and 2 seconds of rest for 20 minutes will be applied sequentially. The amount of pressure applied should be such that the samples feel warm and have mild pain and pressure . Acupressure will be carried out by one of the researchers who has sufficient training in this regard. And in the control group, the touch will be applied without applying pressure with the same pattern when used in the intervention groups used at the same points. The control group will be divided into two groups, and in a touch group at the SP6 point and in the other group, the touch will be at the LI4 point. It should be noted that for all three groups of treatments and routine care will be performed. Then, the severity of pain is measured using the VAS scale immediately (within 5 minutes after the intervention) and 60 minutes after touch and pressure, in order to minimize the effect of the bias curve bias, which means that nine samples No one who measures the severity of pain will not know how to allocate samples to the research (intervention or control) groups.
Participants/Inclusion and exclusion criteria
1. Term pregnancy 2. No previous experience of acupressure 3. Having ages 45-18 years 4. Lack of a lesion at the site of the practice of pressure or touch 5. No addiction 6. Failure to have speech and hearing ability 7. Not having known psychiatric disorders 8. Not having crises such as divorce, loss of loved ones, immigration or .... over the past 6 months 9. Elective cesarean section as a criterion for entry Unwillingness to cooperate with each research unit during the study 2. Those with acute complications after cesarean section (severe bleeding, embolism, etc.) 3. Those who will need to receive housing during the intervention until the second assessment of the severity of pain will be included in the exit criteria.
Intervention groups
In this study, the effect of acupressure is measured at SP6 and LI4 points in an acupressure group at the SP6 point and in the second group at the LI4 point and in the third group, a touch without pressure in one of these points is performed, so that the touch group, half touch LI4 and the other will receive the touch of the Sp6
Main outcome variables
reducing post-cesarean pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171113037426N1
Registration date: 2018-01-13, 1396/10/23
Registration timing: retrospective

Last update: 2018-01-13, 1396/10/23
Update count: 0
Registration date
2018-01-13, 1396/10/23
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34351079
Email address
afh1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Acupressure in LI4 and SP6 Points on Post-Cesarean Section Pain Severity in women
Public title
The Effect of Acuprresure on Cesaerian Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Term pregnancy 2. No previous experience of acupressure 3. Having ages 45-18 years 4. Lack of a lesion at the site of the practice of pressure or touch 5. No addiction 6. Failure to have speech and hearing ability 7. Not having known psychiatric disorders 8. Not having crises such as divorce, loss of loved ones, immigration or .... over the past 6 months 9. Elective cesarean section Exit criteria: 1-Unwillingness to cooperate with each of the research units during the study 2. Those with acute complications after cesarean section (severe bleeding, embolism, etc.) 3- Those who during the intervention until the second assessment of the severity of pain will necessarily need to receive the housing
Exclusion criteria:
Exit criteria:2. Those with acute complications after cesarean section (severe bleeding, embolism, etc.)3- Those who during the intervention until the second assessment of the severity of pain will necessarily need to receive the housing
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 90 women among all women who give birth to cesarean births in Rafsanjan nurseries will be selected in a targeted manner and based on the criteria for entering and leaving the study. Then, they are randomly classified into three groups (two groups of intervention and one control group). So that both groups are consistent with the severity of pain after cesarean section. The first entry in the groups will be random and the rest will be based on the total number of samples in each class. Sampling will continue until the sample size reaches the target. Considering the fact that several factors can affect the pain such as the number of delivery, type of BMSI, age, etc., but ultimately the effect of these factors is measured on the pre-test pain intensity. Therefore, the matching of the three groups based on pre-test pain intensity Is considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Nine specimens, not individuals who measure pain intensity, will not know how to allocate samples to research groups (intervention or control). And to all the sample, even those in the control group will be told that intervention or touch will reduce pain
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Rafsanjan Imam Ali Boulevard, Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
ir.rums.rec.1395.53

Health conditions studied

1

Description of health condition studied
Women undergoing cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by emergency caesarean section

Primary outcomes

1

Description
post ceaerian section
Timepoint
Immediately and hour after study
Method of measurement
for vas scale

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group 1- Acupuncture at Hugo Point (LI4): These subjects, after being fully conscious while lying back, The researcher will use the thumb of both her hands at the Hugo Point on either side of the mother, for 20 consecutive periods of 10 seconds pressure and 2 seconds of resting. The Hugo point is one of the most important points in the intestinal meridian that located behind the hand between the first and second metacarpal bones and at the base of second metacarpal. The pressure will be deeply and applied the researcher nails are made to change color and the mother feels warm and has mild pain and pressure
Category
Treatment - Other

2

Description
Intervention group: 2- Acupressure at the Saninjao Point (SP6): These subjects, after being fully conscious and returning the sensation of lower limbs while lying back, The researcher will be placed at the bottom of the mother foot and face-to-face using the thumb of both hands at the Saninjao Point on either side of the mother will made intervention for 20 consecutive periods of 10 seconds pressure and 2 seconds of resting. SP6 point is located in the meridian of the spleen, and is located at 4 fingers above the inner ankle behind the posterior margin of the tibia. The pressure will be applied deeply until the researcher nails are made to change color and the mother feels warm and mild pain and pressure.
Category
Treatment - Other

3

Description
Control group: After the consciousness and the return of sensation in the lower limbs of these subjects, while lying behind, the researcher will be placed face- to face to them, and in half of them at the Hugo point, and in the other half at the Saninjao point, will touch on either side of the mother without pressure for 20 seconds .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nafe Rafsanjan Maternity Hospital
Full name of responsible person
طیبه نگاهبان بنابی
Street address
Rafeshjan Shohada Street, Nafe Rafsanjan Maternity Hospital Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
negahbant@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
alishmsyzade
Street address
Central Office of Rafsanjan University of Medical Sciences Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3428 0038
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeloripoor
Position
Associate Professor of Rafsanjan Nursing and Midwifery Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Rafsanjan Motahari St. Nursing School, Faculty of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Fax
Email
marzeyehloripoor@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
teyebeh negahban bonabi
Position
Ph.D. Nursing Education Community Health
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan Motahari St. Nursing Nursing Faculty, Faculty of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34255900
Fax
Email
negahban_t@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Afsaneh hasanshahy raviz
Position
Master's degree in Internal and Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Motahari Ave nursing avenue
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3435 1079
Fax
Email
afh1372@gmail.com
Web page address

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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