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The effect of acupressure and touch point (SP6) on pain intensity after delivery 88 qualified mothers give birth on 22 Bahman hospital in Gonabad city

Protocol summary

Summary
This study is a clinical trial which aims to determine the effectiveness of acupressure at the SP6 on pain after delivery will be done .The samples were randomly placed in two groups. This study is a blinded, So that a researcher on clinical samples currently. units reviewed the method used (touch or pressure) do not know. According to statistics consulting with the sample size including 10% attrition, 44 subjects in each group is determined. Inclusion criteria included: Mother's consent, vaginal birth, the second birth, age 37 to 42 weeks of pregnancy, Mother of labor complaints after moderate or severe (a score of 4 or more), having at least Literacy Study, 2500 to 4000 grams birth weight, BMI is between 19.8 to 29 kg per square meter., Delivery without cutting. Child birth physiological. Exclusion criteria included: Maternal use of methods of pain relief, a long and difficult birth, mother's addiction to drugs, cesarean and intra- abdominal surgery،Postpartum hemorrhage and disease. Oxytocin and Augment, not satisfied with the research unit, the uncertainty of the effect of acupressure and fear of the unknown effects. Traumatic child birth. In the intervention group, mothers of hospitalized after giving birth to 2 hours after delivery, constantly checked by the researcher. With the onset of labor after acupressure on severity of pain each time point was recorded.SP6 intervention in the control group in the same way, but without pressure and just touch this point, are found. Interventions for all samples by a single researcher will be done to prevent the emergence of any bias as much as possible.. Measuring pain Visual Analogue Scale (VAS) is.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016070428240N2
Registration date: 2016-08-22, 1395/06/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-22, 1395/06/01
Registrant information
Name
Fatemeh Yaghoobi Moghadam Bilondi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4499
Email address
yaghoobi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrood University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure and touch point (SP6) on pain intensity after delivery 88 qualified mothers give birth on 22 Bahman hospital in Gonabad city
Public title
The effect of acupressure on severity of pain after childbirth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Mother's consent, vaginal birth, the second birth, age 37 to 42 weeks of pregnancy, Mother of labor complaints after moderate or severe (a score of 4 or more), having at least Literacy Study, 2500 to 4000 grams birth weight, BMI is between 19.8 to 29 kg per square meter., physiological Delivery without cutting .and non-traumatic childbirth. Exclusion criteria included: Maternal use of methods of pain relief, a long and difficult birth, mother's addiction to drugs, cesarean and intra- abdominal surgery،Postpartum hemorrhage and disease .No need for Oxytocin and augmented., not satisfied with the research unit, the uncertainty of the effect of acupressure and fear of the unknown effects. Traumatic delivery.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrood University of Medical Sciences
Street address
Shahroud University of Medical Sciences, "Tir" Square, Shahroud, Semnan.
City
Shahroud
Postal code
3614773955
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SHMU.REC.1395.16

Health conditions studied

1

Description of health condition studied
Pain after childbirth
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain

Primary outcomes

1

Description
Pain after childbirth
Timepoint
Baseline to two hours after the intervention.
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
In this group, women in the postpartum hospital stay of up to 2 hours after delivery, constantly checked by the researcher.Whenever the mother of the labor complained, first ruler of her pain with pain that is numbered from 0 to 10 is measured and recorded.The pain and agony average 4 to 7 8 to 10, based on visual rating scale is determined,Sanyinjiao point in both feet first person determined by your fingers and is automatically checked.Then people in the Supine fall, so head above the shoulders is 30 degrees.Thumb bilaterally on the spot and in the clockwise rotational movement of the clock - scattering technique - to apply pressure for 6 seconds.So that people feel tingling, heaviness and heat in their area.Then 2 seconds without pressure, so that the entire 30 minute period;At the end of the technique, using a visual analog scale of pain intensity measured immediately after 30-60-120 minutes. Finally, the pain is compared in the two groups.
Category
Other

2

Description
Sp6 point of intervention in the control group in the same way, but without pressure and just touch this point, are found.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Fateme Yaghoobi
Street address
22 Bahman Hospital, Street Naser Khosro, Gonabad
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Shahrood Univercity of Medical Sciences
City
Shahroud
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh Yaghoobi Moghadam Bilondi
Position
Master Science of Student Counseling Midwiferys
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, "Tir" Square, Shahroud, Semnan
City
Shahroud
Postal code
3614773955
Phone
+98 51 5733 2689
Fax
Email
f.yaghoobi.m@gmail.com;yaghoobi@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Nahid Bolbol Haghighi
Position
MA
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, "Tir" Square, Shahroud, Semnan.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
Email
nbhaghighi349@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh Yaghoobi Moghadam Bilondi
Position
Master Science of Student Counseling Midwiferys
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, "Tir" Square, Shahroud, Semnan.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
Email
f.yaghoobi.m@gmail.com;yaghoobi@shmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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