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Comparison of the effect of acupressure on SP6 point and Rebozo technique on labor pain and experience

Protocol summary

Study aim
Comparison of the average pain score after the intervention during the active phase in the study groups with the control score before the intervention
Design
A single-blind randomized clinical trial, sample size of 90 people including intervention group, acupressure technique, second intervention group, Rebozo technique and third group, control group routine labor care
Settings and conduct
The place of the research is Al-Zahra Educational and Therapeutic Hospital, Taleghani and 29 Bahman, Tabriz and the time of the research is 1402-1403. The necessary information in this research will be completed by the pregnant women and the researcher through questionnaires and checklists.
Participants/Inclusion and exclusion criteria
Inclusion criteria Healthy and singleton pregnant mothers, full-term gestational age, at the beginning of the active phase (4 cm dilatation), cephalic presentation of the fetus, healthy sac of amniotic, existence of a low-risk pregnancy and no medical problems in pregnancy, fetus with an estimated normal weight, no Willingness to receive a painless delivery other than Rebezo and acupressure, not addicted to drugs and smoking Exclusion criteria Mothers with childbirth problems, a history of rapid delivery, a history of chronic systemic, heart, and pulmonary diseases according to the patient's statement and medical record, meconium in the amniotic fluid before the intervention, the presence of any skin disorders and diseases, and bone fractures at the place of acupressure and the Rebozo technique
Intervention groups
One group will be the intervention group, the acupressure technique, the second intervention group will be the Rebozo technique at the beginning of the active phase of labor and the third group will be the control group that will receive routine labor care.
Main outcome variables
labor pain score, labor experience score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110524006582N39
Registration date: 2024-02-12, 1402/11/23
Registration timing: prospective

Last update: 2024-02-12, 1402/11/23
Update count: 0
Registration date
2024-02-12, 1402/11/23
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acupressure on SP6 point and Rebozo technique on labor pain and experience
Public title
Comparing the effect of acupressure and Rebozo technique on labor pain and experience
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy nullipar pregnant mothers Gestational age of term At the beginning of the active phase (4 cm dilatation) Cephalic presentation of the fetus Have a healthy amniotic sac The presence of low-risk pregnancy without medical problems in pregnancy, including blood pressure, gestational diabetes, twin and multiple pregnancy, placenta and amniotic fluid disorders, etc. A fetus with an estimated normal weight Reluctance to receive a painless delivery except for Rebezo and acupressure (remifentanil, other pain relief methods such as massage, breathing, etc.) No addiction to drugs and smoking
Exclusion criteria:
Mothers with birth problems including pre-eclampsia, gestational diabetes, cholestasis, discharge and rupture of the amniotic sac, twin and multiple pregnancies, placenta and amniotic fluid disorders, etc. A history of rapid delivery History of chronic systemic, cardiac, pulmonary diseases according to the patient's self-report and medical records Amniotic fluid meconium before intervention The presence of any disorders and skin diseases and bone fractures in the place of acupressure and Rebozo technique
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were classified by the random block method based on receiving induction or not receiving induction, being nulliparous or multiparous, and the center of the sampling location with block sizes of 3 and 6 and with an allocation ratio of 1:1:1 to three. The group (first group: recipient of acupressure, second group: recipient of Rebozo technique and third group: control group) will be assigned. For Allocation Concealment, the type of intervention will be written on a sheet of paper by a person not involved in the study and placed inside opaque envelopes numbered from 1 to 90. The envelopes will be opened in the order in which the participants entered the study and the type of intervention received will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
This research is a single-blind randomized clinical trial. Only the data analyzer,outcom assessor and data safety monitoring border are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committeeof Tabriz University of Medical Sciences
Street address
No2 central building,3rd floor,University street,Tabriz Univerrsity of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.TBZMED.REC.1402.762

Health conditions studied

1

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

Primary outcomes

1

Description
labor pain score
Timepoint
After the contraction at the beginning of the active phase and before the intervention, then it will be measured every one hour until reaching the second phase and one hour after the end of labor.
Method of measurement
VAS listed line

2

Description
birth experience score
Timepoint
12 to 24 hours after delivery
Method of measurement
Labor Agentry Scale

Secondary outcomes

1

Description
Duration of labor stages
Timepoint
When the dilatation of the cervix reaches 4 cm, it will be recorded in the partograph form.
Method of measurement
Partograph form

2

Description
score of satisfaction with childbirth
Timepoint
12 to 24 hours after delivery
Method of measurement
(Mackey Satisfaction Rating Scale=MCSRS)

3

Description
Apgar score of the baby in the first and fifth minutes
Timepoint
The first and fifth minutes after the birth of the baby
Method of measurement
Baby's Apgar chart

Intervention groups

1

Description
Intervention group: Rebozo recipient group during the active phase (after cervical dilatation reaches 4 cm), while the patient is on his hands and knees or standing, Rebozo is placed around the abdomen or hips, and its ends are in the hands of the midwife (student researcher). - will be seen. Then the researcher will shake the shawl from one side to the other for 20 minutes using small movements. This work will be done with three repetitions in 4-5, 7-8 and 9-10 cm dilatations of the cervix.
Category
Prevention

2

Description
Intervention group: The group receiving acupressure: During the active phase (after cervical dilatation reaches 4 cm), the researcher will apply direct and continuous pressure to the SP6 point with his index finger or thumb, so that when the participant is sitting or lying on the left side, the researcher will press the SP6 point or He will press the Sanyinjiao with his index finger or thumb directly and continuously for one minute. Then 20 to 30 minutes later, pressure will be applied on the opposite leg under the same conditions. This work will be done with three repetitions in 4-5, 7-8 and 9-10 cm dilatations of the cervix.
Category
Prevention

3

Description
Control group: will receive routine labor care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Shaghayegh Aslani
Street address
Army Street, Al-Zahra Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
alzahrahospital@tbzmed.ac.ir

2

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Shaghayegh Aslani
Street address
Railway Square
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3442 8990
Email
taleghani.hos@tbzmed.ac.ir.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parviz Shahabi
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, Deputy Research Area
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shaghayegh Aslani
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Marand City, 3 Timuri Alley Station St
City
Tabriz
Province
East Azarbaijan
Postal code
000000000
Phone
+98 41 4225 9791
Email
Shagayegaslani75@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamali Fard
Position
Assestant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery school, Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3524 5181
Email
Kamalifardm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamali Frad
Position
Assestant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery school, Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
9876598765
Phone
+98 41 3478 5229
Email
Kamalifardm@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
Not applicable
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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