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IRCT20260720070269N1 IRCT 2026-09-10 Ilam University of Medical Sciences Comparison of the Effectiveness of Virtual Reality and Acupressure on Labor Pain Intensity and Anxiety in Women VR vs SP6 Acupressure in Labor Comparison of the Effectiveness of Virtual Reality and Acupressure at the SP6 Point on Labor Pain Intensity and Anxiety in Primiparous Women: A Randomized Clinical Trial 2026-08-23 anticipated 120 Recruiting https://irct.ir/trial/92076 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to the study groups using block randomization with a 1:1:1 allocation ratio. The random allocation sequence will be generated by a computer using randomly permuted blocks, and participants will be assigned according to the predetermined randomization list, Blinding description: This study will be conducted as a single-blind trial. The statistician responsible for data analysis will be blinded to group allocation. The data will be coded before analysis, and the intervention groups will not be identifiable to the data analyst. N/A Nulliparous women with singleton cephalic term pregnancy (37–42 weeks of gestation) in the active phase of labor.. Intervention 1: Control group: Participants receive routine prenatal care according to the health center protocol and do not receive the BASNEF model-based educational intervention. Intervention 2: Intervention group: Participants receive a BASNEF model-based educational program in addition to routine prenatal care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are no plans to share individual participant data (IPD) in order to protect participant confidentiality. Data sharing was not planned in the study protocol.
public Kimia Karimi
Kermanshah
Kermanshah Iran (Islamic Republic of) 1234567898 +98 992 086 2157 raha41709@gmail.com Ilam University of Medical Sciences scientific Kimia Karimi
Kermansha
کرمانشاه Iran (Islamic Republic of) 1234567898 +98 992 086 2157 raha41709@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Nulliparous pregnant women with a singleton, cephalic, term pregnancy (37–42 weeks of gestation).Singleton pregnancy.Intention to undergo vaginal delivery.Ability to understand the study procedures, pain assessment scale, and questionnaire content, and to complete the questionnaires.Voluntary participation in the study and provision of written informed consent.Enrollment during the active phase of the first stage of labor (cervical dilatation >6 cm).Moderate or greater labor pain according to the pain intensity assessment tool.No chronic medical conditions or obstetric complications that could affect labor (e.g., hypertension, gestational diabetes, etc.).No history of psychiatric disorders.Pregnancy not achieved through assisted reproductive technologies (ART).No previous experience with virtual reality technology.No history of receiving systemic analgesics or sedatives before labor that could influence pain intensity or response to non-pharmacological interventions.Absence of fetal abnormalities, including major chromosomal or structural anomalies, fetal growth restriction, amniotic fluid disorders, and significant placental abnormalities. no limit no limit Female Conversion of vaginal delivery to cesarean section at any stage of labor due to obstetric or emergency indications.Occurrence of any acute and unforeseen maternal or fetal complication (e.g., fetal distress, severe hemorrhage, or sudden fetal heart rate abnormalities) that makes continuation of the intervention or data collection impossible, even if cesarean section is not performed. Lifestyle Lifestyle Control group: Participants receive routine prenatal care according to the health center protocol and do not receive the BASNEF model-based educational intervention. Intervention group: Participants receive a BASNEF model-based educational program in addition to routine prenatal care. Labor pain intensity and maternal anxiety during the active phase of labor. Timepoint: Measurements will be taken at baseline, during the active phase of labor, and immediately post-delivery. Method of measurement: Labor pain intensity will be measured using the Visual Analog Scale (VAS), and labor anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). Ilam University of Medical Sciences Approved 2026-07-07 Ethics Committee of Ilam University of Medical Sciences Shahrak Shahrdari, Block 51, Row 3 Kermanshah Kermanshah Iran (Islamic Republic of)