Protocol summary

Summary
Childbirth is arguably one of the most painful experiences women undergo during their lives. This study aimed to compare and recognize the effect of acupressure on the SP6 point and foot reflexology on the intensity of labor pain and the duration of the first stage of labor. Akbar Abadi Hospital in Tehran is chosen as the location of sampling. A total 106 pregnant women in labor will randomly divided into acupressure (35), reflexology (35) and routine care groups (36). Inclusion criteria are primigravid and second birth multigravid women; Iranian race; aged 18 to 35 years old; gestational age of 37 to 42 weeks and absence of chronic diseases. Exclusion criteria include: Caesarean section for any reasons. Acupressure on the SP6 point and reflexology on the solar plexus point (kidney 1) and uterus zone will perform. Mothers in the routine care groups receive routine care. In order to eliminate the effects of psychological support from the presence of researcher, also this group receives a placebo point touch (dorsal region of the foot along with third and fourth finger which is not any pathway meridians). Reflexology and acupressure groups receive interventions in 4 to 5 and 7 to 8 cm cervical dilatation in two 30 min (2 min pressure and 1 min break) on the mentioned points by the researcher. The main outcomes are included pain intensity and duration of the first stage of labor. The intensity of pain record by visual analogue scale (0 to 10 cm) and duration of the first stage measure with Swatch Swiss watch.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201311136807N9
Registration date: 2014-09-27, 1393/07/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-27, 1393/07/05
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Obstetrics department, Valiasr St, Tehran
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of acupressure at SP6 point and foot reflexology on severity of labor pain and duration in the first stage of labor
Public title
Comparing the effect of acupressure at SP6 point and foot reflexology on severity of labor pain and duration in the first stage of labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: primigravid and second birth multigravid women; Iranian race; 18-35 years old; at least an elementary school education; singleton pregnancy; live fetus with cephalic presentation; women in the start of active phase of labor; the presence of regular uterine contractions (three contractions in 10 minutes); the gestational age of 37 to 42 weeks (the first day of the last menstrual period (LMP) or ultrasound under 12 weeks ); no history of infertility indication Caesarean section; to having a intact amniotic sac or to not past rupture of membranes for more than 12 hours; low risk pregnancy (absence of bleeding in the third trimester; placenta previa; abruption; intrautrine growth restriction) absence of the risk of chronic diseases such as: heart disease, pulmonary, hypertension, diabetes, according to the patient file; not suffering from skin diseases such as: eczema, skin infections and wart in legs; lack of any problems that may lead to the mother's inability to communicate (deafness, blindness); no history of acupressure and reflexology in the past. Exclusion criteria: the client required a Caesarean delivery for any reason (abnormal fetal heart rate pattern; no breakthrough bleeding pregnancy; arrest of labor) mother's unwillingness to continue doing acupressure and or foot reflexology.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization performs by the permutation blocking method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the International Branch of Shahid Beheshti University of Medical Sciences and H
Street address
No19, Shahid Abbasspour Street, Valiasr Street,Tehran
City
Tehran
Postal code
14155-3693
Approval date
2014-05-03, 1393/02/13
Ethics committee reference number
116/346

2

Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Sciences and Heath Services
Street address
Hemmat freeway (beside Milad Tower), Tehran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1680/105/د/92

Health conditions studied

1

Description of health condition studied
delivery
ICD-10 code
O80-O84
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
intensity of pain
Timepoint
Befor 4-5 and 7-8 cm cervical dilatation and 30 minutes after mentioned dilatation
Method of measurement
Visual Analogue Scale

2

Description
Duration of first stage of labor.
Timepoint
From the beginning of 4 cm until 10 cm cervical dilatation.
Method of measurement
Watch ecueped seconds counter.

Secondary outcomes

1

Description
Duration of second stage of labor
Timepoint
From 10 cm dilatation cervix to full expose of fetus
Method of measurement
Swiss Swatch watch

2

Description
Duration of third stage of labor
Timepoint
From full expose of fetus to full expose of placenta
Method of measurement
Swiss Swatch watch

3

Description
First and fifth minutes of apgar.
Timepoint
One and five minutes after birth.
Method of measurement
Standard Apgar Index.

4

Description
Method of delivery
Timepoint
After delivery
Method of measurement
Observation

5

Description
Satisfactory of method of relief labor pain.
Timepoint
After delivery
Method of measurement
Questioner

6

Description
Amount of pain relief
Timepoint
After delivery
Method of measurement
Questioner

7

Description
Tendency to use of pain relief method again
Timepoint
After delivery
Method of measurement
Questioner

Intervention groups

1

Description
Acupressure group: in this group, the SP6 point (where is located in the four fingers above the medial malleouse at the posterior tibia) will be under pressure in two 30-minutes stages from 4 to 5 and 7 to 8 cm dilatation (every two minutes and then rest for one minute until the end of each thirty minutes) by the researcher.
Category
Treatment - Other

2

Description
Reflexology group: in this group uterine zone (located under the medial malleolus foot) and the solar plexus (in the superior and middle border line in the sole) will be under pressure in two 30-minutes stages from the start of 4 to 5 and 7 to 8 cm dilatation (every two minutes and then rest for one minute until the end of each thirty minutes) by the researcher.
Category
Treatment - Other

3

Description
Routine care group: in this group routine care will be done for samples. Also this group received a placebo point touch (dorsal region of foot along with third and fourth finger which is not any pathway meridians).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Sedigheh Amir Ali Akbari
Street address
Molavi Street, Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of the international branch of Shahid Beheshti University of Medical Sc
Full name of responsible person
Mrs Amir Ali Akbari
Street address
No19, Shahid Abbasspour Street, Valiasr Street, Tehran.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of the international branch of Shahid Beheshti University of Medical Sc
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
Obstetrics department of Shahid Beheshti
Full name of responsible person
Mr Amir Ali Akbari
Position
MSc of Midwifery/ lecturer
Other areas of specialty/work
Street address
Obstetrics department, Valiasr Street, Tehran.
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
asa_akbari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti Medical Sciences and Health University
Full name of responsible person
Mrs Amir Ali Akbari
Position
Msc
Other areas of specialty/work
Street address
Obstetrics department, Valiasr Street, Tehran.
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
asa_akbari@yahoo.com
Web page address

Person responsible for updating data

Contact

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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