Protocol summary
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Study aim
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Investigating the effect of pressure on GB21 on labor pain severity and length of delivery
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Design
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Clinical trial, community-based, and pragmatic control group, with parallel groups, blind, randomized,
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Settings and conduct
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Mothers who are admitted to the active phase of labor, selected according to inclosion criteria. After giving explanations to individuals, they are randomly divided into separate rooms. Intervention teams are unaware of how to intervene. How to handle the pain assessment The pain intensity before the intervention, immediately after the intervention, is 30 minutes and 60 minutes after the intervention using a pain reliever. The results are recorded in the checklist and the examination is recorded. although during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages will measured
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: primiparous; age18-35 years; cephalic presentation; Gestational age 37-41 weeks; Singleton; ability to read and write; tendency to use analgesia; be in active phase;
Exclusion criteria: not having willingness to work with researcher; Conditions lead to cesarean section
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Intervention groups
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Pressure group on GB 21; Pressure group on shame point; Control group
In the pressure group on GB 21, the researcher pushes his right hand over the point. Using pressure during uterine contractions.
In the pressure group on the shame point with the conditions, the pressure is applied to theshame point.
In the control group, the researcher only performs the necessary measures in labor.
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Main outcome variables
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Severity of labor pain؛ Satisfaction of the treatment course, length of delivery
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100503003860N34
Registration date:
2018-04-17, 1397/01/28
Registration timing:
registered_while_recruiting
Last update:
2019-12-04, 1398/09/13
Update count:
1
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Registration date
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2018-04-17, 1397/01/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-20, 1396/12/01
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Expected recruitment end date
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2018-09-21, 1397/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of pressure on bile duct 21 on labor pain severity and length of delivery in primiparous women
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Public title
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The effect of pressure on bile duct 21 on labor pain severity and length of delivery in primiparous women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Be primiparous
cephalic presentation
ability to read and write
18-35years
Gestational age 37-41 weeks and Singletonage
tendency to use analgesia
be in active phase
Exclusion criteria:
Do not have to work with a researcher
Conditions lead to cesarean section
high risk pregnancies
skin disorders
chronic diseases
mental and anatomical disorders
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
174
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The appointment of individuals in groups was randomized using the RANDOM ALLOCATION SOFTWARE FOR CLINICAL TRIAL software. Using this software, information about the sample number, the number of groups, the groups names will be taken into the data and output software, which includes the list of random groups of the groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, a full description of the research is given to the research units at first, and the patient is given written consent for participation in the study. Then Pregnant mothers are placed in separate rooms to avoid being aware of the intervention. In the control group only routine care is applied
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-05-22, 1396/03/01
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Ethics committee reference number
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IR.SBMU.PHNM.1395.705
Health conditions studied
1
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Description of health condition studied
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labor pain
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Severity of labor pain
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Timepoint
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Before the intervention,Immediately after intervention, 30 minutes and 60 minutes after intervention
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Method of measurement
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Numerical rating scale
2
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Description
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Length of Delivery
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Timepoint
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during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage
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Method of measurement
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minutes
Secondary outcomes
1
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Description
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Mode of delivery
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Timepoint
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once-after delivery
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Method of measurement
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Questioner
2
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Description
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Neonatal Apgar Score
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Timepoint
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1 and 5 minute after birth
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Method of measurement
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check list
Intervention groups
1
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Description
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first Intervention group: In the intervention group with acupressure on the bile duct 21, the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured.
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Category
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Other
2
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Description
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Intervention group 2: The second group is pressure on shame point. This point is located between 1 and 2 thumbs from the point of the Gallbladder21 at the outside of the body.the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured
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Category
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Other
3
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Description
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Control group: The third group is the control group. This group receives all routine care except for intervention.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The results of the study will be divided into two parts: the length of delivery and the severity of pain
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When the data will become available and for how long
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After publishing the results as an article
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To whom data/document is available
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Researchers working in academic places
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Under which criteria data/document could be used
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Respecting copyright and solely in order to help the researcher to conduct his more accurate study
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From where data/document is obtainable
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correspond email
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What processes are involved for a request to access data/document
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By sending an email and after reviewing the request, it will be answered in case of discretion
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Comments
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