Comparing the effects of red and near-infrared light diode radiation with acupressure on pain intensity and length of the first stage of labor in primiparous women
Comparison of the effect of red and near-infrared LED radiation with acupressure on pain intensity and length of the first stage of labor in primiparous women.
Design
It is a two-group randomized clinical trial that will be conducted on 90 primiparous pregnant women in Umm al-Binin Hospital (S) in Mashhad.
Settings and conduct
This research will be carried out at Umm al-Banin Hospital in Mashhad. People are randomly divided into LED light and acupressure groups. Interventions in Hugo and Sanyingiao acupressure points will be performed in dilations 4-5, 7-6, and 9-8. Interventions will be in the form of light radiation with wavelengths of 660 and 850 in the amount of 3 joules of energy per LED for 10 minutes in the light radiation group and pressing the above points for 10 minutes for each point in the acupressure group.
Participants/Inclusion and exclusion criteria
Primiparous pregnant women with the following criteria: active labor, cephalic presentation, term fetus, singleton and weighing 2.5 to 4 kg, absence of medical disease, and obstetric complications will be included in the study. In case of any obstetric complications such as bleeding and fetal heart rate disorders, the pregnant mother will not be included in the study.
Intervention groups
The main intervention group: pregnant mothers who will receive LED light radiation in the Hugo and Saninjiao points in addition to the routine care of childbirth in the three stages of dilatation.
Control group: The control group includes pregnant mothers who, in addition to receiving routine care during childbirth, such as maternal vital signs, fetal heart rate check, and acupressure at Hugo and Sanyingiao points.
Main outcome variables
Intensity of labor pain, duration of first stage of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230725058918N1
Registration date:2023-08-30, 1402/06/08
Registration timing:registered_while_recruiting
Last update:2023-08-30, 1402/06/08
Update count:1
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Fahime Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3287 3748
Email address
yas.raha1373@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of red and near-infrared light diode radiation with acupressure on pain intensity and length of the first stage of labor in primiparous women
Public title
The effect of red and infrared LED light on labor pain and length
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A pregnant mother aged 18-35 must be primiparous, single, and Iranian.
Have a fetus with cephalic presentation with a gestational age of 37-41 (based on LMP or ultrasound of the first trimester of pregnancy).
Having literacy in reading and writing and the absence of speech and hearing problems that prevent communication with the interventionist.
Signed the written consent form.
The estimated weight of the fetus (based on Johnson criteria or third trimester ultrasound) should be between 2.5-4 kilos.
Cerebral-pelvic disproportion and fetal anomaly have not been diagnosed.
The onset of labor should be spontaneous based on 4 cm dilation and regular uterine contractions.
Absence of drug and alcohol addiction, as well as not having used narcotics for 8 hours before the intervention.
Do not have medical diseases.
Do not have obstetric complications.
Do not have a history of surgery on the uterus or cervix.
Do not have lesions such as wounds, scratches, burns, eczema, or other lesions on the skin that prevent light therapy.
Exclusion criteria:
In case of any obstetric complications such as bleeding and fetal heart rate disorders, the pregnant mother will not be included in the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research will be easy based on entry and exit criteria. Allocation of people to two groups will be random and based on the sequence generated by the site https://www.sealedenvelope.com, blocks of four without replacement. Allocation of code A or B to each of the groups will be based on lottery.
To hide the allocation, the closed envelope method is used in such a way that a number of envelopes, preparation, and each of the randomly created sequences are recorded on a card and the cards are placed inside the envelopes in order. At the time of selecting the research units, based on the order of entry into the study, the envelopes are opened and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad, Mashhad Faculty of Nursing and Midwifery, Doctor's intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-07-26, 1402/05/04
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.064
Health conditions studied
1
Description of health condition studied
Labor pain intensity and length of the first stage of labor
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery, Prolonged first stage (of labor)
Primary outcomes
1
Description
Pain intensity of labor
Timepoint
Measurement of pain score and pain intensity upon entering the study, then after intervention in cervical dilatations of 4-5, 7-6 and 8-9 cm
Method of measurement
Pain score and intensity will be measured through the visual analog pain scale tool and McGill short pain questionnaire.
2
Description
Length of first stage of labor
Timepoint
The length of the first stage of labor will be measured by the universal partograph form.
Method of measurement
The length of the first stage of labor will be calculated from the time the pregnant mother enters the active phase (at the time of entering the study) until the dilatation of 10 cm of the cervix.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Irradiation of LED light in each of Hugo and Suningyao acupressure points for 10 minutes in dilations 4-5, 7-6 and 9-8
Category
Treatment - Devices
2
Description
Intervention group: Squeezing Hugo and Suningyao points for 10 minutes for each point in 4-5, 6-7, and 8-9 dilatations.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Umm al-Binin Hospital, Mashhad
Full name of responsible person
Dr. Masoume Mirtimori
Street address
Mashhad, Ayatollah Behjat St., 16 Behjat
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734767
Phone
+98 51 3223 1061
Email
oah@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Kayani
Street address
University Street, Doctor's Crossroad, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Nouri
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
nourif4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samira Ebrahimzadeh Zagami
Position
Assistant Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Mashhad Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
EbrahimzadehZS@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Nouri
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing and Midwifery Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
nourif4001@mums.ac.ir
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