Protocol summary

Summary
Aim : The aim of the study is Comparison the effect of BL32 and GB21 points acupressure with P6 point acupressure on labor pain in first stage of labor in parturant women. Material and Methods: In a single blind clinical trial samples will select from nuliparus, singleton, vertex pregnant women refer to Arak Taleghani Hospital for delivery and do not have any med surge disease or obstetrical complications and agree to participate in the study. Samples will randomly divide into 2 groups including 65 persons in each group. Intervention group is received BL32 and GB21 points acupressure and control group is received placebo p6 point acupressure with cupping method for one minute in the start of every contraction in the first stage of labor with 3-4 cm cervical dilatation. Samples will blind about allocating in intervention or control group. Pain severity will measure using VAS tool before and after intervention in each contraction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206079965N1
Registration date: 2012-07-01, 1391/04/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-01, 1391/04/11
Registrant information
Name
Nafiseh Seyyedzadeh Aghdam
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3500
Email address
seyedzadeh.n@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Science
Expected recruitment start date
2005-01-01, 1383/10/12
Expected recruitment end date
2005-09-03, 1384/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of BL32 and GB21 points acupressure effect with P6 point acupressure on decrease of labor pain in first stage of labor in parturant women
Public title
acupressure effect on the labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; nulliparous ; singleton ; vertex; parturant women ;first stage of labor; 3-4 cm dilatation; Exclusion criteria: medical and surgical disorders; obstetrical complications; they don,t like participant in study;
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Science
Street address
Arak University of Medical Science, Sardasht, Arak
City
Arak
Postal code
38481-76941
Approval date
2004-09-22, 1383/07/01
Ethics committee reference number
120

Health conditions studied

1

Description of health condition studied
labor pain
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery

2

Description of health condition studied
labor pain
ICD-10 code
Z37.0
ICD-10 code description
Single live birth

3

Description of health condition studied
labor pain
ICD-10 code
Z38.0
ICD-10 code description
Singleton born in hospital

Primary outcomes

1

Description
labor pain
Timepoint
before and after intervention in every contraction
Method of measurement
with use of VAS

Secondary outcomes

empty

Intervention groups

1

Description
In contol group that are parturant women with 3-4 cm dilatation in start of every contaction , pain severity by use of VAS tool is measured then P6 point acupressure is performed for one minute and then pain severity by use of VAS tool is measured again. The samples are blinded about intervention and control group.
Category
Other

2

Description
In ntrvention group samples that are parturant women with 3-4 cm dilatation ,in start of every contaction first pain severity is measured by VAS tool and then BL32 and GB21 points acupressure is performed with use of cupping method for one minute and pain severity is measured by VAS tool again. The samples are blinded about inter vention g or control group s.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Nafise Seyyedzadeh Aghdam
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Mr. Akbari
Street address
Arak University of Medical Science , Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science
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
Arak University of Medical Science
Full name of responsible person
Nafiseh Seyyedzadeh Aghdam
Position
Member of Nursing Midwifery Faculty
Other areas of specialty/work
Street address
Nursing Midwifery Faculty- Sardasht- Arak
City
Arak
Postal code
Phone
+98 86 1417 3500
Fax
Email
seyedzadeh.n@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Nafiseh Seyyedzadeh Aghdam
Position
Member of Nursing Midwifery Faculty
Other areas of specialty/work
Street address
Nursing Midwifery Faculty- Sardasht- Arak
City
Arak
Postal code
Phone
+98 86 1417 3500
Fax
Email
seyedzadeh.n@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Nafiseh Seyyedzadeh Aghdam
Position
Member of Nursing Midwifery Faculty
Other areas of specialty/work
Street address
Nursing Midwifery Faculty - Sardasht- Arak
City
Arak
Postal code
Phone
00
Fax
Email
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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