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The Study of Effect of Acupressure in SP6 on Labor Pain and Labor Outcome in Women During Labor

Protocol summary

Summary
This experimental study is a single-blind clinical trial with random allocation. The population under study consisted of 18-35 year-old women who had singleton pregnancy; parity of 1 or 2; 38-42 gestational age and cervical dilatation of 3-5cm. Exclusion criteria: lack of consent; oxytocin dose in excess of routine requirements and any sign of fetal distress such as a heart rate of over 160 or less than 110beats/min, late decelerations, thick meconium staining and prolonged or precipitate labor, newborn weighing less than 2500 or more than 4000 grams. Initially, 172 individuals were randomly selected and 21 people from the experimental group (pressure), 5 people from the first control group (touch), and 15 people from the second control group (conventional care) were excluded from the study. Ultimately, 131 individuals, consisting of 41 subjects in the pressure group, 41 in the touch control group and 49 in the conventional care group were studied.During 30 minutes intervention, the experimental group received pressure on SP6 and first control group received touch on SP6 with deep breathing and relaxation. The second control group (common care) was only encouraged to breathe deeply and stay relax.In this study, we evaluated the efect of this intervention on delivery duration, anxiety level in mother and using popular medicine in labor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812193527N1
Registration date: 2012-05-13, 1391/02/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-13, 1391/02/24
Registrant information
Name
Parisa Samadi
Name of organization / entity
Abadan branch, Eslamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3809
Email address
sabaghzadeh@iaud.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University.
Expected recruitment start date
2008-04-03, 1387/01/15
Expected recruitment end date
2008-11-21, 1387/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of Effect of Acupressure in SP6 on Labor Pain and Labor Outcome in Women During Labor
Public title
The Effect of Acupressure on Labor Pain and Labor Outcome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 35 years-old pregnant women; 38-42 weeks gestational age; parity of 1 or 2; no use of psycho-therapeutics nor labor induction medications prescribed by physician or midwife; no use of chemical or natural pain killers prior to the study; cervical dilatation of 3-5cm; BMI less than 29; devoid of any medical or obstetrical problems such as uterine myomas, pre-cancerous lesions, cephalopelvic disproportion, infertility or surgical operation on uterus or cervix, placenta previa, placental abruption, poly- or oligohydramnios, erythroblastosis fetalis, preeclampsia, gestational diabetes, decreased fetal movements; no use of tobacco (e.g., smoking, hubble bubble, drugs) or alcohol and no verbal, auditory, or mental problems. Exclusion criteria: lack of consent; oxytocin dose in excess of routine requirements and any sign of fetal distress such as a heart rate of over 160 or less than 110beats/min, late decelerations, thick meconium staining and prolonged or precipitate labor, newborn weighing less than 2500 or more than 4000 grams
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 131
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
Tarbiat Modares University
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway,Tehran, Iran
City
Tehran
Postal code
P.O.Box: 14115-111
Approval date
2008-02-17, 1386/11/28
Ethics committee reference number
150/75148

Health conditions studied

1

Description of health condition studied
Labor Pain and Delivery out come
ICD-10 code
O80-O84
ICD-10 code description
Delivery

Primary outcomes

1

Description
Labor Pain intensity
Timepoint
Before intervention, immediately following 2 minutes' intervention, after 30 minutes' intervention and 30 minutes post-intervention
Method of measurement
Visual Analog Scale

2

Description
Labor duration
Timepoint
Labor duration was documented in two time periods ,first time period, dilatation of 3cm to complete cervical dilatation; and second time period, from complete cervical dilatation to delivery time.
Method of measurement
Cervical dilatation by vaginal exam and at cm

Secondary outcomes

1

Description
Anxiety
Timepoint
Before intervention , after 30 minutes' intervention and 30 minutes post-intervention
Method of measurement
FAS

2

Description
Analgesic taking
Timepoint
Before and through intervention they did not take any analgesic
Method of measurement
Amount of analgesic taking

3

Description
Delivery type
Timepoint
After labour
Method of measurement
Registration in questionnaire

Intervention groups

1

Description
pressure at SP6:30-minute pressureas follows: At first, a 2-minute pressure was applied in a way that a pleasant feeling of pain would be experienced by the subject. Care was taken to keep the degree of paleness of the nail at a constant level and the subject pleased with the pressure. Subsequently, regardless of contractions, one minute of pressure followed by a minute's rest was applied intermittently until the pressure time equaled an overall 30 minutes. It took one hour to perform this technique every time.
Category
Treatment - Other

2

Description
Touch at SP-6:in the same schedule touch at SP-6 was applied in the first control group
Category
Treatment - Devices

3

Description
The second control group (common care) was only encouraged to breathe deeply and stay relax.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Maryam Taamin Ejtemai hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mansooreh Movahedin PhD
Street address
Tarbiat Modares University, nasr bridj, jalal al ahmad high way, tehran, iran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Minoor Lamyian
Position
Assistant professor
Other areas of specialty/work
Street address
Tarbiat Modares University, nasr bridj, jalal al ahmad high way, tarbiat modares university
City
tehran
Postal code
Phone
+98 21 8288 3809
Fax
Email
lamyianm@modares.ac.ir pmfsamadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Abadan branch, Eslamic Azad University
Full name of responsible person
parisa samadi
Position
academic saff and MSc of midwifery
Other areas of specialty/work
Street address
Abadan branch, Eslamic Azad University, infront of taleghani hospital, abadan, khoozestan, iran
City
abadan
Postal code
Phone
+98 63 1222 8017
Fax
Email
pmfsamadi@yahoo.com lamyianm@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Abadan branch, Eslamic Azad University
Full name of responsible person
parisa samadi
Position
academic staff and MSc of midwifery
Other areas of specialty/work
Street address
Abadan branch, Eslamic Azad University, infront of taleghani hospital, abadan, khoozestan, iran
City
abadan
Postal code
Phone
+98 63 1222 8017
Fax
Email
pmfsamadi@yahoo.com
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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