Investigating the effect of two methods of auriculotherapy and reflexology on the intensity of labor pain and the duration of the active stage
Design
Clinical trial with intervention and control group, with parallel groups, single-blind, randomized, phase 3 on 96 patients. For randomization, simple randomization is done using Random Allocation software..
Settings and conduct
This study will be conducted in Bahar Shahrood Hospital. Patients are randomly divided into three groups using Random Allocation software. The most important outcome evaluated in this study is the intensity of labor pain and the duration of the active phase of labor. In order to obtain data on this outcome, the intensity of labor pain will be measured first at 4 cm dilatation, then at 6 and 8 cm dilatation. The statistical analyst does not know how the groups are coded and the blinding of one strain is done..
Participants/Inclusion and exclusion criteria
Low-risk pregnancy (no placental placenta, no polyhydramnios, reduced fetal movements and IUGR)
Gestation age 37-40 weeks
3. Cephalic presentation
4. Singleton pregnancy
5. First pregnancy
6. 4 cm dilation and uterine contractions for 30 seconds and 2-3 contractions in 10 minutes
7. Age between 18-35 years
8. 19/9 < body mass index < 25/9
9. Having minimum literacy
10. Having at least one healthy ear
11. Having at least one healthy leg (absence of cuts, burns, fungal infections, warts, warts and any kind of numbness in the leg)
12. Has a safe water bag
13. No history of infertility
14. Absence of cesarean indications
15. Declaration of informed consent
Intervention groups
First intervention group: Auriculotherapy .The second intervention group: Refluxology metho and Control group: routine care method is used.In each of the methods, 20 minutes of massage will be done twice.
Main outcome variables
Pain intensity, pain duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220910055928N1
Registration date:2022-10-31, 1401/08/09
Registration timing:registered_while_recruiting
Last update:2022-10-31, 1401/08/09
Update count:0
Registration date
2022-10-31, 1401/08/09
Registrant information
Name
ZEYNAB Ameri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3251 3250
Email address
zeynabameri2014@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two methods of uriculotherapy and reflexology on the severity of labor pain and the durationof the active stage of labor
Public title
The effect of two methods of uriculotherapy and reflexology on the severity of labor pain and the durationof the active stage of labor
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
obtaining informed consent.
Low-risk pregnancy (not having a placenta, no polyhydramnios, reduced fetal movements, as well as IUGR
Gestation age 37-40 weeks
Singleton pregnancy
Cephalic presentation
4 cm dilation and uterine contractions for 30 seconds and 2-3 contractions in 10 minutes
Age between 18-35 years
Having at least reading and writing literacy
Having at least one healthy ear
Having at least one healthy foot (absence of cuts, burns, fungal infections, warts, warts, and any kind of numbness in the foot)
Has a safe water bag
Exclusion criteria:
Receiving painkillers within 3 hours before the start and during the study
Drug addiction
Using oxytocin to induce and accelerate childbirth
Emergency caesarean section for any reason before the completion of the first stage of labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using Random Allocation software and simple randomization method, and people are examined in one of three groups. Then prepare 96 numbered envelopes that contain the treatment method code and the informed consent form, and one of the envelopes will be assigned in the order of number when people enter.
Blinding (investigator's opinion)
Single blinded
Blinding description
To prevent the study analyst from knowing, each group will be assigned a code that only the researcher will know about their interpretation, and coded information will be delivered to the statistical consultant for analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrood University of Medical Sciences
Street address
Shahrood University of Medical Sciences, Heftam Tir Square, Tehran Street
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Approval date
2022-07-30, 1401/05/08
Ethics committee reference number
IR.SHMU.REC.1401.128
Health conditions studied
1
Description of health condition studied
The effect of reflexology and auriculotherapy on the severity of labor pain
ICD-10 code
061
ICD-10 code description
Failed induction of labour
Primary outcomes
1
Description
severity of labor pain
Timepoint
Time intervals of pain intensity measurement by visual pain scale will be done first at 4 cm dilatation and then at 6 and 8 cm dilatation.
Method of measurement
The way to measure the outcome variable will be a horizontal ruler (visual scale of pain).
2
Description
the duration of the active phase of labor
Timepoint
Time intervals of pain intensity measurement by visual pain scale will be done first at 4 cm dilatation and then at 6 and 8 cm dilatation.
Method of measurement
The way to measure the outcome variable will be a horizontal ruler (visual scale of pain)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: In the auriculotherapy group, after disinfecting the ear in the lobe of the ear, on the points located in the figure (1-1, 1-2, and 1-3), including the parts of the uterus, pituitary gland, pelvis, adrenal gland, endocrine gland and the point of Shan Man, spleen point and the thoracos point, pressure is applied once at 4 cm dilatation and again at 6 to 8 cm dilatation for 20 minutes each. Then the researcher will observe the mother until delivery and after that.
Category
Treatment - Other
2
Description
The second intervention group: gentle massage on the entire sole of the foot, and then pressure will be applied on the specified and relevant areas. These areas will include the pituitary gland, right in the center of the big toe of both feet, the solar plexus approximately four toes wide below the base of the toes of both feet and in the center. The genital area is located below the ankles of both legs and on both sides. Reflexology will be performed for 20 minutes on each leg for a total of 40 minutes starting with 4 cm dilation and entering the active phase of labor by the researcher, and again at 6 and 8 cm dilation, then the researcher until the time of delivery and after that. will monitor the mother.
Category
Treatment - Other
3
Description
Control group: In the control group Zao will receive only routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
Zainab Ameri
Street address
22 Bahman Street, in front of the Children's Park, Bahar Hospital
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3222 4091
Email
zeynabAmeri2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
zeynab Ameri
Street address
Seventh Tir Square, Shahrood University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3222 4091
Email
zeynabameri2014@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
zeynab Ameri
Position
midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ghafari Street, Shahid Arab Asadi Alley
City
Shahrood
Province
Semnan
Postal code
3655119402
Phone
+98 23 3251 3250
Email
zeynabameri2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
zeynab Ameri
Position
midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ghafari Street, Shahid Arab Asadi Alley
City
Shahrood
Province
Semnan
Postal code
3655119402
Phone
+98 23 3251 3250
Email
zeynabameri2014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
zeynabameri
Position
midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ghafari Street, Shahid Arab Asadi Alley
City
shahrood
Province
Semnan
Postal code
3655119402
Phone
+98 23 3251 3250
Email
zeynabameri2014@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
Yes - There is a plan to make this available
Title and more details about the data/document
Main implications of the study.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
It will be used to cite the source in the articles and any other type of analysis will be done in consultation with the first author of the article
From where data/document is obtainable
To receive the desired documents or data, please email Ms. Zainab Ameri, Master of Midwifery Counseling, working at Bahar Hospital, at ameri.z@shmu.ac.ir or call 00982332395054.
What processes are involved for a request to access data/document
To receive documents or other items after applying, they will receive a clear answer within two weeks.