Protocol summary

Summary
In this quasi-experimental study of 165 nulliparous women were randomly assigned to three groups. First group: Acupressure, Group II: ice massage and group III: control. Each group included 55 women from the first and had a singleton.Elective cesarean section did not turn on and display the fetus was vertex. Other methods of analgesia and anesthesia during labor were not used.When entering the study and 37 weeks of pregnancy and dilation 4-3 cm or more had had.Oxytocin was not used for all units of study.If there is one - bleeding 2 - fetal distress 3 - the patient's unwillingness to cooperate were excluded from the intervention.Intervention at 4-3 cm dilatation and at the point LI-4 was applied. Intervention period was 30 minutes.A group of acupressure and massage in the group of ice were used.Labor pain, length of labor and anxiety levels in the three groups represented by the graph of pain (VAS) and the Spielberger Inventory position in two stages (before and after intervention) were evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102222515N2
Registration date: 2012-07-25, 1391/05/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Maasumeh Kaviani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4251
Email address
kavianm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-05-05, 1390/02/15
Expected recruitment end date
2011-09-16, 1390/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of, acupressure and ice massage in Hoku area on the severity of labor pain, Anxiety Status and time of labor in primiparous Women Referred to labor Room of Shoshtary Hospital, Shiraz, 1389.
Public title
Effect acupressure and ice massage on pain intensity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: physically healthy singleton nulliparous women who had no limit to the intervention (Preeclampsia, premature rupture of membranes and seizures, and ....); not planed for elective caesarean section and display the Vertex fetus; no use of other methods of analgesia and anesthesia during labor; when entering the study had Dilation 4-3 cm and 37 weeks of pregnancy or more and Oxytocin was not used. Exclusion criteria: bleeding; fetal distress and the patient's unwillingness to intervene
Age
From 18 years old to 31 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 165
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
Shiraz University of Medical Sciences Ethics Committee
Street address
Zand st.
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CT-89-5191

Health conditions studied

1

Description of health condition studied
no disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Severity of labour pain
Timepoint
Half an hour and during uterine contractions
Method of measurement
Visual Analoug Scale

2

Description
Anxiety status
Timepoint
While dilatation is 4-3 cm, one hour before and after intervention
Method of measurement
Spielberger state Questionnaire

Secondary outcomes

1

Description
Apgar score
Timepoint
After birth
Method of measurement
Apgar score table

Intervention groups

1

Description
Acupressure group at 4-3 cm cervical Tasyvn Dyla half an hour and start uterine contractions by the researcher on the right hand thumb, LI-4 on the left hand and left hand with thumb pressure by the researcher on the LI-4 The decrease was in the right hand.With 1277 MMHG (Kg3) was measured under the thumb of the left hand end of the uterine contractions push came to an end. In order to ensure there is no pressure difference between right and left by thumb pressure using the formula P = F / A (P pressure in millimeters of mercury, F and A-level finger forces in kilos per square meter ) has been calculated.help the researcher. In the ice massage for half an hour during each contraction of the thumb and index finger point between the two meta-carpal area called Hugo (LI-4) decrease in right and left hands with a small bag of ice (frozen Ykhmkhay) about the massage and the end of each contraction was stopped. Ice bags were replaced every 10 minutes due to reduced effectiveness.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Maasoumeh Kaviani
Street address
Shiraz, Namazi
City
Shiraz

2

Recruitment center
Name of recruitment center
Shooshtari Hospital, Shiraz
Full name of responsible person
Asefi
Street address
Bascule Nader- Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz - Zand Street - Next to the Red Crescent - Sakhtmtn Central University - Class 7 - Research
City
shiraz
Grant name
Grant code / Reference number
4712
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maasoumeh Kaviani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
Kavianm@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maasoumeh Kaviani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Shiraz, Namazi square
City
Shiraz
Postal code
Phone
Fax
Email
kavianm@sums.ac.ir
Web page address
www.sums.ac.ir

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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