The comparison of effectiveness of acupressure six spleen and Hugo point on the severity of postpartum pain
Design
A clinical trial with two intervention groups and no control group, randomized in parallel and one-sided, phase 3 on 68 primiparous pregnant women. For randomization, the block randomization method will be used using blocks of 6.
Settings and conduct
This clinical trial study will be conducted on 68 eligible primiparous pregnant women referred to Farabi Hospital in Malekan city after obtaining the necessary permits. Mothers will be examined in the post-partum department at least two hours and at most three hours after delivery. The pain intensity of mothers who have given birth naturally will be recorded with a pain ruler. People in one of the two categories of moderate (score -4-6) or severe (score 7-10) using the visual pain scale are selected by the available method and then randomly divided into two groups.
intervention group (acupressure point 6 spleen)
Intervention group (acupressure point of Hugo
Participants/Inclusion and exclusion criteria
Inclusion Criteria: being primiparous, being in the first trimester of pregnancy, not having previous experience with acupressure, not having a lesion at the place where acupressure is applied, not having problems in the ability to speak, hear and see, not being addicted, not having known mental disorders, not having Crises such as divorce, loss of loved ones, immigration or... during the last 6 months.
Exclusion criteria: Unwillingness to cooperate with any of the research units during the study, occurrence of complications after normal delivery (heavy bleeding, embolism, etc.) The usual pain reliever in case of severe back pain is diclofenac suppository 100 mg).
Intervention groups
Intervention group (acupressure point 6 spleen)
Intervention group (Hugo point acupressure)
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220910055926N1
Registration date:2022-09-13, 1401/06/22
Registration timing:prospective
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Saba Mohammadghasemnezhadmaleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
sabamgm1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of acupressure six spleen and Hugo point on the severity of postpartum pain
Public title
The comparison of effectiveness of acupressure six spleen and Hugo point on the severity of postpartum pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous
Term of pregnancy
No previous experience of acupressure
Not having a lesion at the place of applying acupressure
Having no problems in speech, hearing and vision
No addiction
Not having known mental disorders
Not having crises such as divorce, loss of loved ones, immigration or... during the last 6 months.
Exclusion criteria:
Reluctance to cooperate
Complications after natural delivery (heavy bleeding, embolism, etc.)
There is a need to receive additional painkillers outside of the usual department during the study (the usual painkillers of the department in case of severe back pain, diclofenac 100mg suppositories).
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method using 6 blocks will be used. A third person who is not involved in the process of diagnosing and evaluating patients will create a random sequence using the site: https://www.sealedenvelope.com and based on the sample size, 12 blocks of 6 will be created. Each patient will be given a unique code that can be created on this site.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, in order to prevent bias of the interventionist, data collection is done by another person who does not perform the intervention, who does not know about the allocation of the participants in the research groups. In the current study, there is no possibility of blinding the researcher because he is aware of the acupressure points and the stimulation of the points is done by him, but since the participants do not have previous experience of acupressure and do not know where the two desired points are located, the study is a Sue is blind. Also, the information analyst does not know about the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah Province, Kermanshah, Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
۵۵۶۱۶۴۹۸۳۱
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.KUMS.REC.1401.251
Health conditions studied
1
Description of health condition studied
Severity of labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of labor pain
Timepoint
Before, immediately after and one hour after the intervention
Method of measurement
Visual Analouge Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Spleen point 6 acupressure: Acupressure intervention at spleen point 6 and intervention at Hugo point are applied bilaterally, in periods of 10 seconds of pressure and 2 seconds of rest for 20 minutes consecutively. The amount of applied pressure is such that the samples feel warm and have slight pain and pressure. Spleen pressure point 6 is in the Spleen meridian and is located 5 cm above the inner angle of the tibia, and the location of the Hugo point is anatomically in the back of the hand between the first and second metacarpal bones and almost along the radial bone.
Category
Treatment - Other
2
Description
Hugo point acupressure: Acupressure intervention at spleen point 6 and intervention at Hugo point are applied bilaterally, in periods of 10 seconds of pressure and 2 seconds of rest for 20 minutes consecutively. The amount of applied pressure is such that the samples feel warm and have slight pain and pressure. Spleen pressure point 6 is in the Spleen meridian and is located 5 cm above the inner angle of the tibia, and the location of the Hugo point is anatomically in the back of the hand between the first and second metacarpal bones and almost along the radial bone.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital, Malekan City
Full name of responsible person
Saba Mohamad Ghasem Nezhad Maleki
Street address
Farabi Malekan hospital; Shahriar Blvd, Malekan, East Azerbaijan
City
Malekan
Province
East Azarbaijan
Postal code
۵۵۶۱۶۴۹۸۳۱
Phone
+98 41 3784 1979
Email
sabamgm1992@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sosan Heidarpour
Street address
Kermanshah, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
۵۵۶۱۶۴۹۸۳۱
Phone
+98 83 3828 2101
Email
s.heydarpour1394@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Saba Mohamad Ghasem Nezhad Maleki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kermanshah, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
۵۵۶۱۶۴۹۸۳۱
Phone
+98 83 3828 2101
Email
sabamgm1992@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saba Mohamad Ghasem Nezhad Maleki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kermanshah, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
۵۵۶۱۶۴۹۸۳۱
Phone
+98 83 3828 2101
Email
sabamgm1992@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saba Mohamad Ghasem Nezhad Maleki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kermanshah, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
۵۵۶۱۶۴۹۸۳۱
Phone
+98 83 3828 2101
Email
sabamgm1992@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available