Determination and Compare the Effect Of Hot And Cold Massages On Point Six Spleen Reducing Labor Pain
Design
Double-blind clinical trial, purpose-based and accessible, with parallel groups and a sample size of 40 people per group
Settings and conduct
This research will be carried out at the Maternity Hospital of Amiralmomenin Hospital in Zabol city. In order to determine the severity of pain before intervention in dilatation of 5-3 cm, after 2 times of uterine contraction and pain expression, the mother is asked to determine the pain score on the pain reliever. . To determine the SP6 point, people are asked to place their 4 fingers next to the ankle and the researcher points to the correct SP6 point. Couples' days with hot massage and the days of intervention with Massagh.
Participants/Inclusion and exclusion criteria
Physical and mental health; dilatation of 4-5cm; literacy in terms of number comprehension; single pregnancy; cephalic presentation and gestational age 38-40 week. Exit conditions include preeclampsia, induction of childbirth; opioid use in the last 8 hours ; Lack of progress; maternal hip disorder ; maternal underlying disease; any lesions in the area under the massage.
Intervention groups
Hot and cold massage group. In the ice group, ice molds will be used in diameter of 2 cm. For hot massage from hot water bag with temperature of 38 to 40 ° C.
Main outcome variables
Labor pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039632N2
Registration date:2018-06-15, 1397/03/25
Registration timing:retrospective
Last update:2018-06-15, 1397/03/25
Update count:0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Sanaz Nehbandani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 8046
Email address
snehbandani2013@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hot and cold massage on sph6 spot (SP6) on pain reduction in active phase of labor
Public title
The effect of SP6 SPOT massage on labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Physical and mental health
Cervical dilation 4-5 cm
Literacy in the comprehension of numbers
Single and Precursor Pregnancy
Cephalic presentation
Gestational age 38-40 week
Exclusion criteria:
Preeclampsia
Induction of childbirth
Drug use within the last 8 hours
Lack of delivery
Pelvic disproportion of the fetus mother
Mother's underlying illness
There is any lesion in the massage site
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Intervention is done by the researcher in two groups, and an assessment of the severity of pain will be done by a person who is unaware of how to do the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zabol University of Medical Sciences
Street address
No8. Taleghani street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861784678
Approval date
2017-07-11, 1396/04/20
Ethics committee reference number
Zbmu.1.REC.1396.117
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Labor pain
Timepoint
The pain test will be measured 5 minutes after the intervention, 30 minutes after massage and 30 minutes after the intervention.
Method of measurement
McGill Pulse Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the ice massage group, 2 cm diameter ice molds will be used. The ice mold will be placed in a nylon bag. The dosage will be rotated in 30 minutes, so that, starting with the intervention, no restraint is given for 1 minute massage and 1 minute, so that the total amount of massage time to 30 minutes.
Category
Other
2
Description
The second intervention group will be used for hot massage from the hot water bottle at a temperature of 38 to 40 ° C. The dosage will be rotated in 30 minutes so that massage begins at the beginning of the intervention, regardless of contractions. Rest 1 minute, so that the total duration of the massage reaches 30 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zabol Amiralmomenin Hospital
Full name of responsible person
SanazNehbandani
Street address
Street Taleghani,Taleghani 47,Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861784678
Phone
+98 54 3222 8046
Email
snehbandani2013@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Kadije Rezaie keikhaie
Street address
Ferdowsi 3,Ferdowsi Street, Zabol Nursing and Midwifery Faculty,
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3223 0765
Email
snehbandani2013@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Sanaz Nehbandani
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 8,Taleghani 47
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861784678
Phone
+98 54 3222 8046
Fax
Email
snehbandani2013@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Sanaz Nehbandani
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 8,Taleghani 47
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861784678
Phone
+98 54 3222 8046
Fax
Email
snehbandani2013@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Sanaz Nehbandani
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 8,Taleghani 47
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861784678
Phone
+98 54 3222 8046
Fax
Email
snehbandani2013@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data of this research will be published in the form of the article.
When the data will become available and for how long
2018
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For scientific studies
From where data/document is obtainable
Sanaz Nehbandani2013@zbmu.ac.ir
What processes are involved for a request to access data/document
After discussion in the Council is able to send data.