Interferential Current and Transcutaneous Electrical Nerve Stimulation for Pain After Cesarean Section (IC-TENS-CS)

Comparison of the Effects of Interferential Current and Transcutaneous Electrical Nerve Stimulation on Pain Following Cesarean Section

This study aims to compare the immediate and short-term effects of interferential current therapy and conventional transcutaneous electrical nerve stimulation (TENS) with placebo stimulation on pain and postpartum comfort following cesarean section. A total of 54 primiparous women aged 18-40 years will be randomly assigned to an interferential current, TENS, or placebo group. Each intervention will be administered for 30 minutes. Pain intensity at rest and during in-bed activities will be assessed before the intervention, immediately after the intervention, and at 1 and 2 hours after the intervention. Postpartum comfort, treatment satisfaction, anxiety, and depression will also be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain After Cesarean Section
• Intervention / Treatment: Device: Conventional TENS; Device: Interferential Current Therapy; Device: Placebo Electrical Stimulation

Detailed Description

This is a prospective, randomized, placebo-controlled, three-arm clinical trial conducted in the Obstetrics and Gynecology Department of Menteşe State Hospital. The study will include 54 primiparous women following cesarean section. Eligible participants who provide written informed consent will be randomly allocated to the conventional TENS group, interferential current therapy group, or placebo stimulation group.

All interventions will be administered in the supine position with a pillow placed under the knees. Four self-adhesive electrodes will be positioned around the cesarean incision. Conventional TENS will be applied at a frequency of 125 Hz and a pulse duration of 60 microseconds. Interferential current therapy will be applied using a fixed frequency of 100 Hz. In both active intervention groups, current intensity will be increased to a strong but comfortable sensory level and adjusted throughout the session to maintain the same sensation. In the placebo group, the electrodes and device will be applied in the same manner, but no electrical current will be delivered. Each intervention will last 30 minutes.

An assessor blinded to group allocation will perform all evaluations. Pain intensity at rest and during in-bed activities will be assessed using separate 0-10 cm visual analog scales before the intervention, immediately after the intervention, and at 1 and 2 hours after the intervention. Postpartum comfort will be evaluated before the intervention and 2 hours after the intervention using the Postpartum Comfort Questionnaire. Treatment satisfaction will be assessed immediately, 1 hour, and 2 hours after the intervention. Baseline anxiety and depression levels will be evaluated using the Hospital Anxiety and Depression Scale.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dilara Özen Oruk, PhD; Phone Number: +902522112072; Email: dilaraozen@mu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Muğla, Turkey (Türkiye), 48000
    • Recruiting
    • Menteşe State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women aged 18 to 40 years
• Ability to read, write, and communicate in Turkish
• Primiparous women
• Having delivered a healthy singleton infant by cesarean section
• No additional surgical procedure or complication during or after the cesarean section

Exclusion Criteria:

• Impaired orientation or cooperation
• History of systemic disorders, including hyperglycemia or hypertension, gastrointestinal disorders, or urogynecological disorders
• Previous abdominal surgery
• Neurological, orthopedic, cardiopulmonary, or other health conditions that may prevent mobilization or ambulation
• Previous experience with transcutaneous electrical nerve stimulation or interferential current therapy
• Contraindications to electrical stimulation, including sensory loss at the application site, dermatological problems or allergic reactions at the application site, or a cardiac pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional TENS; Participants will receive one 30-minute session of conventional transcutaneous electrical nerve stimulation following cesarean section.	Device: Conventional TENS; Conventional TENS will be applied for 30 minutes at a frequency of 125 Hz and a pulse duration of 60 microseconds. Four self-adhesive electrodes will be positioned around the cesarean incision. Current intensity will be increased to a strong but comfortable sensory level and adjusted during the session to maintain the same sensation.
Experimental: Interferential Current Therapy; Participants will receive one 30-minute session of interferential current therapy following cesarean section.	Device: Interferential Current Therapy; Interferential current therapy will be applied for 30 minutes using a fixed frequency of 100 Hz. Four self-adhesive electrodes will be positioned around the cesarean incision in a crossed arrangement. Current intensity will be increased to a strong but comfortable sensory level and adjusted during the session to maintain the same sensation.; Other Names: IFC
Placebo Comparator: Placebo Stimulation; Participants will receive one 30-minute session of placebo electrical stimulation following cesarean section.	Device: Placebo Electrical Stimulation; The electrodes and stimulation device will be applied in the same position and for the same 30-minute duration as in the active intervention groups; however, no electrical current will be delivered.; Other Names: Sham Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity at Rest	Pain intensity at rest will be assessed using a 10-cm Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes from baseline will be compared among the three groups.	Baseline, immediately after the 30-minute intervention, 1 hour after the intervention, and 2 hours after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Postpartum Comfort	Postpartum comfort will be assessed using the Postpartum Comfort Questionnaire. The questionnaire contains 34 items covering physical, psychospiritual, and sociocultural comfort. Total scores range from 34 to 170, with higher scores indicating greater postpartum comfort.	Baseline and 2 hours after the intervention
Treatment Satisfaction	Treatment satisfaction will be assessed using a 10-cm Visual Analog Scale ranging from 0 (not satisfied at all) to 10 (very satisfied). Higher scores indicate greater treatment satisfaction.	Immediately after the intervention, 1 hour after the intervention, and 2 hours after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association Between Psychological Symptoms and Change in Pain Intensity	Anxiety and depression symptoms will be assessed at baseline using the Hospital Anxiety and Depression Scale. The scale consists of 14 items divided into anxiety and depression subscales, each ranging from 0 to 21. Higher scores indicate greater symptom severity. The associations between baseline anxiety and depression scores and changes in pain intensity following the interventions will be examined.	From baseline to 2 hours after the intervention

Collaborators and Investigators

• Sponsor: Dilara Özen Oruk
• Investigators: Principal Investigator: Dilara Özen Oruk, PhD, Muğla Sıtkı Koçman University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 22, 2026
• First Submitted That Met QC Criteria: September 22, 2026
• First Posted (Actual): September 29, 2026

Study Record Updates

• Last Update Posted (Actual): October 2, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: TENS; Cesarean Delivery; Transcutaneous Electrical Nerve Stimulation; Postpartum Comfort; Acute Postoperative Pain; Nonpharmacological Pain Management; Interferential Current Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy
• Other Study ID Numbers: MSKU-CS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be made publicly available because the dataset contains sensitive obstetric and health information, and public data sharing was not included in the informed consent process.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No