Protocol summary
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Study aim
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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.
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Design
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A phase 2, randomized, two-group, unblinded clinical trial using convenient sampling will be conducted in Umm al-Banin (S) and Hasheminejad hospitals in Mashhad on 90 primiparous pregnant women. Randomization was performed using the website sealedenvelope.com.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Intensity of labor pain, duration of first stage of labor
General information
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Reason for update
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The estimated date for sampling differed from the exact sampling time and needed to be corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230725058918N1
Registration date:
2023-08-30, 1402/06/08
Registration timing:
prospective
Last update:
2025-06-22, 1404/04/01
Update count:
1
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Registration date
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2023-08-30, 1402/06/08
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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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2023-07-23, 1402/05/01
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Expected recruitment end date
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2024-02-19, 1402/11/30
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Actual recruitment start date
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2023-11-22, 1402/09/01
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Actual recruitment end date
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2024-03-05, 1402/12/15
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Trial completion date
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2024-03-05, 1402/12/15
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Scientific title
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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
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Public title
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The effect of red and infrared LED light on labor pain and length
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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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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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
Actual sample size reached:
81
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2023-07-26, 1402/05/04
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Ethics committee reference number
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IR.MUMS.NURSE.REC.1402.064
Health conditions studied
1
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Description of health condition studied
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Labor pain intensity and length of the first stage of labor
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ICD-10 code
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O80.0
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ICD-10 code description
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Spontaneous vertex delivery, Prolonged first stage (of labor)
Primary outcomes
1
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Description
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Pain intensity of labor
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Timepoint
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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
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Method of measurement
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Pain score and intensity will be measured through the visual analog pain scale tool and McGill short pain questionnaire.
2
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Description
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Length of first stage of labor
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Timepoint
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The length of the first stage of labor will be measured by the universal partograph form.
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Method of measurement
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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.
Intervention groups
1
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Description
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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
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Category
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Treatment - Devices
2
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Description
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Intervention group: Squeezing Hugo and Suningyao points for 10 minutes for each point in 4-5, 6-7, and 8-9 dilatations.
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Category
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Treatment - Other
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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Mashhad 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