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Comparsion of pressure in the bladder-Gv20 and Gall bladder-GV20 on Intensity Labour Pain and Coping among Primiparturient Women

Protocol summary

Study aim
Comparison of pressure in the bladder points -GV20 and gallbladder-GV20 on the severity of labor pain in primiparous women. 2. Comparison of pressure in the bladder spots -GV20 and gallbladder-GV20 on the coping ability of labor pain in primiparous women.
Design
In this study, 165 nulliparous women refering to Umm Al Binhayn Hospital for delivery were chosen purposefully and randomly divided into three groups: 1 (gallbladder), intervention 2 (bladder) And common care (control).
Settings and conduct
The research units were randomly assigned into intervention1, intervention2 and control groups. The intervention group 1 received pressure on the GV20 and the bladder points (BL5-BL8-BL9), and in the intervention group 2 pressure on the GV20 and the points Gall bladder (GB8-GB16-GB17-GB18). Thus, in the active phase of the labor (5-4 cm dilatation) every point for 60 seconds; and in the intervention group one 4 minutes of pressure and in the intervention group two, 5 minutes of pressure; applied every 30 minutes by the researcher;so that the sum pressure in each of the two intervention groups were 20 minutes (5 cycles in the intervention group 1 and 4 in the intervention group 2). In the latent phase of the second stage of labor, 60 second pressure is applied to each of the points (a pressure cycle). For assessing the progress of labor vaginal examination is performed every 2 hours. The severity of pain and the ability to coping with pain before intervention ;immediately after intervention and half an hour after the intervention, and then every half hour until the end of the second stage of labor, is examined and recorded. To assess the progress of labor, the modified form of the Organization of Health World used.
Participants/Inclusion and exclusion criteria
Entry requirements; Nulliparous, Single pregnancy, Cephalic presentation fetus,The appropriateness of the fetus with the mother's pelvis, Gestational age 37 weeks and more, Estimated fetal weight 4000-2500 grams, Spontaneous onset of labor, Pain intensity at the beginning of the study is a score of 50 and more, Healthy skin is a pressure area. Conditions of failure to enter;Speech-audio problems, Drug Addiction and Drinking, History of referral to psychiatrist or psychologist, Medical disease; obstetric complications, History of operation on the uterus or cervix, Taking the medication within 24 hours prior to onset of labor, Severe anxiety at the start of the study.
Intervention groups
Intervention group 1: Pressure on GV20 and bladder points (BL5-BL8-BL9) Intervention group 2: Pressure on the GV20 and gallbladder points (GB8-GB16-GB17-GB18) Control group: Get regular care
Main outcome variables
The severity of pain; The ability to deal with pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170503033796N2
Registration date: 2018-02-21, 1396/12/02
Registration timing: registered_while_recruiting

Last update: 2018-02-21, 1396/12/02
Update count: 0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
Elahe Mansouri Ghzelhesari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
mansourie941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Midwifery, Mashhad
Expected recruitment start date
2017-06-06, 1396/03/16
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of pressure in the bladder-Gv20 and Gall bladder-GV20 on Intensity Labour Pain and Coping among Primiparturient Women
Public title
Comparative study of the scalp acupressure on the pain and the ability to cope with pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Muslims and Iran Age from 18 to 35 years old Written Consent Form nulliparous singleton pregnancy cephalic fetal presentation gestational age 37 weeks and more Fit the head of the fetus with the mother's hip fetal weight between 4000-2500 grams Spontaneous onset of labor (5-4 cm dilated with contractions 20 seconds and at least two more within 10 min) healthy skin pressure areas Pain intensity is 50 or more at the start of the study
Exclusion criteria:
Speech-auditory or dialectal problems Drug Addiction, Drinking and Tobacco History of referral to a psychiatrist or psychologist, drug use or hospitalization due to mental illness in the past year Major stress in the last year Cure for medical conditions Decided to cesarean section The presence of midwifery problems History of operation on the uterus or cervix Use of a prescription by a doctor or midwife or herbal medicine within the last 24 hours for the onset of labor pain Oral temperature equal to or greater than 38 ° C Severe anxiety at the start of the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 165
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, each of the units was selected as available and then random allocation (assignment for the three primary patients in 3 groups was randomized and the same order was observed for other patients until the end of the study) in 3 groups of intervention and control they got.
Blinding (investigator's opinion)
Single blinded
Blinding description
With regard to the LDR's rooms, none of the research units were in contact with each other, and thereforethey were not aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Unit 1, Ghoreshi building, Daneshgah Street, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MUMS.REC.1396.40

Health conditions studied

1

Description of health condition studied
Labor pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Coping with Labor Pain
Timepoint
Before the intervention and a half hours until delivery
Method of measurement
Observational questionnaire of coping with labor pain

2

Description
Labor pain
Timepoint
Before the intervention and a half hours until delivery
Method of measurement
Visual analog scale pain

Secondary outcomes

1

Description
Labor progress
Timepoint
From the time of admission (5-4Santy dilation of the cervix) until delivery
Method of measurement
Partogragh modified World Health Organization

Intervention groups

1

Description
Intervention group:With each contraction points of GV20-BL5-BL8-BL9 is pressed for 60 seconds (a total of 4 minutes). The compressor was housed half an hour at the beginning of the contraction and in a 4-minute cycle (60 seconds each) for 5 consecutive cycles. In the latent phase of the second stage of labor, with the onset of uterine contraction, a pressure cycle is applied to each of the points.
Category
Treatment - Other

2

Description
Intervention group: With each contraction points of GV20- GB8-GB16-GB17-GB18 is pressed for 60 seconds (a total of 4 minutes). The compressor was housed half an hour at the beginning of the contraction and in a 4-minute cycle (60 seconds each) for4 consecutive cycles. In the latent phase of the second stage of labor, with the onset of uterine contraction, a pressure cycle is applied to each of the points.
Category
Treatment - Other

3

Description
Control group: Caring for the usual maternity ward at U-Al-Banin Hospital includes taking a vegan, helping in changing clothes, bedding, pads, hearing a fetal heart's sound every half hour
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Um Al-Benin Specialized Women's hospital
Full name of responsible person
Masoumeh Mirtaimouri
Street address
Behjat 16, Ayatollah Behjat street, Zarrineh Crossroad, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734767
Phone
+98 51 3223 1061
Email
Mirteimourim@mums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
M. Tafaqodi
Street address
Unit 1, Ghoreshi bilding, Daneshgah street,Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 7313
Email
tafaghodim@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Elaheh Mansouri Ghezel Hesari
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doktora Crossroads, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3589 1511
Fax
Email
mansourie941@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Kordi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
KordiM@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elaheh Mansouri Ghezel hesari
Position
Midwifery Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
mansourie941@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We do not plan to publish information about the participants
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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