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NCT07933263
The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Mobilization, and Insomnia Severity After Cesarean Section: A Randomized Controlled Trial
Conditions: Postoperative Pain After Cesarean Section, Early Postpartum Mobilization, Postpartum Sleep
Sex: Female
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Inonu University
Location: Battalgazi Devlet Hastanesi, Malatya, Türkiye Malatya
Summary
This study is designed using an experimental research model with a pre-test-post-test control group.
The study population consists of women receiving postpartum care following a cesarean section. The sample size was determined through a power analysis using the G\*Power software; based on an effect size of d=0.80, an alpha (α) level of 0.05, and a power of 0.95, a minimum of 33 women per group was calculated. Accounting for a potential 10% attrition rate, a total of 72 women-36 in the experimental group and 36 in the control group-will be included in the study. Participants will be assigned to the groups using a simple randomization method.
The experimental group will receive Transcutaneous Electrical Nerve Stimulation (TENS) three times, beginning prior to mobilization. TENS will be applied for 20 minutes at a frequency of 20-40 Hz, a pulse duration of 90-100 µs, and an intensity level tolerable for the participant. The control group will receive no interventions other than routine care.
Data will be collected using a Personal Information Form, the Visual Analog Scale (VAS), the Patient Mobility Scale (PMS), the Observer Mobility Scale (OMS), and the Insomnia Severity Index (ISI). Pre-test measurements will be taken before the first intervention, and post-test measurements will be taken prior to hospital discharge.
Data will be analyzed using the SPSS 29.0 software; descriptive statistics, the chi-square test, and independent and dependent samples t-tests will be employed. A significance level of p\
Eligibility Criteria
Inclusion Criteria:
Women who are able to communicate verbally and are literate, who have no diagnosed psychiatric conditions, and who experienced no complications related to themselves or their infants during the postpartum period will be included in the study.
Exclusion Criteria:
Women who experienced serious complications (such as hemorrhage, infection, etc.) during or after a cesarean section, or who have contraindications for TENS application (e.g., use of a cardiac pacemaker), will be excluded from the study.
Source: ClinicalTrials.gov (NCT07933263). StuddyBuddy aggregates publicly available trial information.