Protocol summary
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Study aim
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Determining the effect of acupressure of BL25 points on the intensity of active phase pain and the outcome of childbirth in pregnant women referred to Imam Ali Hospital in Amol in 1402-1403.
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Design
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Clinical trial with control and sham groups, with parallel groups, single-blind, randomized, on 90 patients. The randomization will be done using the Random Allocation Software.
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Settings and conduct
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The research environment is the maternity ward of Imam Ali Hospital in Amol. The sampling method is purpose-based sampling, the pregnant women referred for childbirth, if they are willing to participate in the study and have the characteristics of the research units, are considered as the research sample. Before the beginning of the sampling, with the help of the software, the random order of assigning people to the groups is specified by the supervisor from 1 to 90 and is placed inside the envelope. On the envelope, the number related to the sequence of the person's entry into the research is written, but the researcher will not know the type of group of people before starting the intervention.
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Participants/Inclusion and exclusion criteria
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Entry conditions: term singleton pregnancy with vertex presentation, mother's absence of chronic disease and pregnancy complications. Conditions of non-entry: the mother's unwillingness to continue participating in the study and the occurrence of adverse side effects
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Intervention groups
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Intervention in the acupressure group is performed on BL25 and Sham points for 20 minutes during uterine contractions in three stages (dilatation of 4-5, 6-7, and 8-10 cm) and a total of 60 minutes. The control group will receive all the care of the intervention groups, except acupressure.
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Main outcome variables
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Pain intensity of the first stage and the outcome of childbirth in pregnant women.
General information
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Reason for update
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Modification of the primary variable part of the time section field: the measurement of pain intensity before the intervention and 10 minutes after the intervention and immediately after the intervention was changed to the measurement of pain intensity before the intervention and immediately after the intervention.
Secondary variable section: The field of secondary variables was added.
Due to the delay in the expected start of sampling, the start date was changed.
Modification of the section responsible for scientific accountability was changed from the name of the student to the supervisor.
Modification of the sponsoring officer section was changed from the name of the student to the official of the university.
Correction of the address of the patient care center and the place to receive the code of ethics
/Change the title from primiparous women to pregnant women
/Adding pregnant women (do not have more than one vaginal delivery) In the entry criteria section
/Changing the sampling site hospital
/Sampling has not started yet and the expected date has changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240121060761N1
Registration date:
2024-02-07, 1402/11/18
Registration timing:
prospective
Last update:
2024-06-05, 1403/03/16
Update count:
2
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Registration date
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2024-02-07, 1402/11/18
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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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2024-07-04, 1403/04/14
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Expected recruitment end date
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2024-11-19, 1403/08/29
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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 BL25 Acupressure on Pain Intensity in the First Stage of Labor, And Birth outcome in Pregnant Women
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Public title
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The Effect of Acupressure on Pain Intensity in the First Stage of Labor
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
pregnant women (do not have more than one vaginal delivery)
Do not have a history of more than one miscarriage
Gestational age between 37-42 weeks (according to ultrasound before 12 weeks or LMP)
Single ton , Vertex Presentation
Dilatation 4-5 cm (at the beginning of the active phase of labor)
The presence of at least three contractions in 10 minutes
The appropriateness of the pelvic position
Failure to use analgesic drugs (chemical or herbal) in the last 8 hours
Absence of chronic disease such as cardiovascular disease, kidney disease, joint rheumatism and epilepsy
Not suffering from a known mental illness
No history of unfortunate events, such as the death of a spouse or a close relative during pregnancy
Absence of complications during pregnancy such as pre-eclampsia, chorioamnionitis, etc.
Absence of obstetric complications (such as decollement, abnormal fetal heart rate, etc.) upon entering the study
Exclusion criteria:
Mother's unwillingness to continue participating in the study
Emergency caesarean section (after registration)
Occurrence of adverse outcomes (placental detachment, fetal distress, lack of progress in labor) (after registration)
Use of other non-pharmacological pain reduction methods (after registration)
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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:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Agreeable and eligible people will be selected to enter the study and after giving sufficient explanations about the goals and groups, written consent will be obtained from the samples. Then, randomly, people will be placed in three acupressure groups of BL25 points, Sham (placebo) acupressure points, and control. Random Allocation Software will be used to assign people to groups randomly. In this way, before the beginning of sampling with the help of the software, the order of the random sequence of assigning people to groups is determined by the supervisor from 1 to 90 and placed inside the envelope. On the envelope, the number related to the sequence of the person entering the research is written, but the researcher will not know the type of group of people before the intervention. After assigning people to groups, the envelope is opened and the type of research unit group is determined for the researcher. The research units will also be informed that they will be in the control or intervention group, but they will not be informed about whether they are in the BL25 or Sham acupressure group. Also, these numbers are recorded as codes on the observation and examination checklist and the information form of the research units so that the type of people's group is hidden during data entry into SPSS.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Agreeable and eligible people will be selected to enter the study and after giving sufficient explanations about the goals and groups, written consent will be obtained from the samples. Then, randomly, people will be placed in three acupressure groups of BL25 points, Sham (placebo) acupressure points, and control. Random Allocation Software will be used to assign people to groups randomly. In this way, before the beginning of sampling with the help of the software, the order of the random sequence of assigning people to groups is determined by the supervisor from 1 to 90 and placed inside the envelope. On the envelope, the number related to the sequence of the person entering the research is written, but the researcher will not know the type of group of people before the intervention. After assigning people to groups, the envelope is opened and the type of research unit group is determined for the researcher. The research units will also be informed that they will be in the control or intervention group, but they will not be informed about whether they are in the BL25 or Sham acupressure group. Also, these numbers are recorded as codes on the observation and examination checklist and the information form of the research units so that the type of people's group is hidden during data entry into SPSS.
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Placebo
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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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2024-01-15, 1402/10/25
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1402.194
Health conditions studied
1
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Description of health condition studied
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The effect of BL25 acupressure on pain intensity in the first stage of labor, and birth outcome in pregnant women
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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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The pain intensity of the first stage of labor in pregnant women is measured by a numerical pain rating scale. The pain intensity scale is a number between zero and 10, where zero indicates no pain and 10 indicates the most severe pain.
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Timepoint
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Pain intensity is measured before the intervention, and immediately after the end of the intervention, in cervical dilatations of 4-5 cm, 6-7 cm and 8-10 cm.
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Method of measurement
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The pain intensity of the first stage of labor is measured with a numerical pain rating scale. The pain intensity scale is a number between 0 and 10, where 0 represents no pain and 10 represents the most severe pain.
Secondary outcomes
1
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Description
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The duration of the second stage of labor
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Timepoint
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From the completion of cervical dilatation until the complete expulsion of the fetus
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Method of measurement
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Observation and examination checklist
2
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Description
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The duration of the third stage of labor
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Timepoint
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From the exit of the fetus to the complete exit of the placenta and membranes
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Method of measurement
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Observation and examination checklist
3
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Description
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Need to resuscitate the baby
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Timepoint
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Postpartum
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Method of measurement
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Observation and examination checklist
4
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Description
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Apgar score of the baby
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Timepoint
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Postpartum
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Method of measurement
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Observation and examination checklist
5
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Description
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Bishop's score
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Timepoint
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In cervical dilatations of 4-5, 6-7 and 8-10 cm
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Method of measurement
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Observation and examination checklist
6
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Description
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Frequency of uterine contractions
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Timepoint
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In cervical dilatations of 4-5, 6-7 and 8-10 cm
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Method of measurement
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Observation and examination checklist
7
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Description
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Intensity of uterine contractions
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Timepoint
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In cervical dilatations of 4-5, 6-7 and 8-10 cm
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Method of measurement
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Observation and examination checklist
8
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Description
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Duration of uterine contractions
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Timepoint
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In cervical dilatations of 4-5, 6-7 and 8-10 cm
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Method of measurement
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Observation and examination checklist
9
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Description
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Need oxytocin
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Timepoint
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Postpartum
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Method of measurement
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Observation and examination checklist
10
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Description
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The need for pharmaceutical pain relief methods
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Timepoint
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Postpartum
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Method of measurement
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Observation and examination checklist
11
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Description
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Mother's satisfaction with pain relief
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Timepoint
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Postpartum
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Method of measurement
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Likert's questionnaire
Intervention groups
1
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Description
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Intervention group:BL25 acupressure group, intervention in BL25 acupressure points in dilatations of 4-5, 7-6 and 8-10 cm for 20 minutes and a total of 60 minutes, during uterine contractions, with the help of two thumbs of the researcher's hand. In order to prevent discomfort, deep and circular pressure is applied around the BL25 points until the researcher's nail changes color. In each dilatation, after the end of the contraction, the pressure will stop and start with the start of the next contraction. This action is repeated for 20 minutes during contractions. In addition, all the routine measures that are provided to the patients hospitalized in the delivery department, including FHR control, vaginal examination, administration and control of the first, second (except for delivery) and third stage of labor, assessment of labor problems, assessment of problems at birth And.... will also be done for all the people in the groups.
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Category
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N/A
2
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Description
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Intervention group: Acupressure of Sham (placebo) points, Acupressure for the Sham group was performed on points near BL25 (2.5 Cun outside of BL25) in exactly the same way as the acupressure group. In addition, all the routine measures that are provided to the patients hospitalized in the delivery department, including FHR control, vaginal examination, administration and control of the first, second (except for delivery) and third stage of labor, assessment of labor problems, assessment of problems at birth And.... will also be done for all the people in the groups.
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Category
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N/A
3
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Description
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Control group: In the control group, the researcher is present at the bedside of the pregnant mother, and all the measures that are performed for the control groups, including encouraging the continuation of breathing during contractions, without pressure on the BL25 and Sham points, are also performed for this group. Like the control groups, the researcher is with the people from the 4 cm dilatation of the cervix until the end of delivery at certain times and for the same period of time and provides them with emotional support. The intensity of pain in the intervals mentioned for this group will be measured by the numerical pain rating scale, just like the case groups.
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Category
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N/A
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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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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Undecided - It is not yet known if there will be 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