Interferential Current and Transcutaneous Electrical Nerve Stimulation for Pain After Cesarean Section

NCT07847502 | Recruiting

• 1 other identifier: MSKU-CS-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain After Cesarean Section

Keywords

Transcutaneous Electrical Nerve Stimulation; TENS; Interferential Current Therapy; Cesarean Delivery; Postpartum Comfort; Acute Postoperative Pain; Nonpharmacological Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Postpartum Comfort

  Baseline and 2 hours after the intervention

• Treatment Satisfaction

  Immediately after the intervention, 1 hour after the intervention, and 2 hours after the intervention

Other Outcomes (1)

• Association Between Psychological Symptoms and Change in Pain Intensity

  From baseline to 2 hours after the intervention

Study Arms (3)

Conventional TENS

ACTIVE COMPARATOR

Participants will receive one 30-minute session of conventional transcutaneous electrical nerve stimulation following cesarean section.

Device: Conventional TENS

Interferential Current Therapy

EXPERIMENTAL

Participants will receive one 30-minute session of interferential current therapy following cesarean section.

Device: Interferential Current Therapy

Placebo Stimulation

PLACEBO COMPARATOR

Participants will receive one 30-minute session of placebo electrical stimulation following cesarean section.

Device: Placebo Electrical Stimulation

Interventions

Interferential Current Therapy DEVICE

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.

Also known as: IFC

Interferential Current Therapy

Placebo Electrical Stimulation DEVICE

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.

Also known as: Sham Stimulation

Placebo Stimulation

Conventional TENS DEVICE

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.

Conventional TENS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only women who have undergone cesarean section are eligible because the study evaluates pain and postpartum comfort following cesarean delivery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dilara Özen Oruk: lead

Study Sites (1)

Menteşe State Hospital

Muğla, 48000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Dilara Özen Oruk, PhD

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilara Özen Oruk, PhD

CONTACT

+902522112072; dilaraozen@mu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed of their treatment allocation. Outcome assessments will be performed by a physiotherapist who is blinded to group allocation. The physiotherapist administering the interventions will not be blinded because the stimulation parameters must be adjusted during treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant, PhD

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to the conventional TENS, interferential current therapy, or placebo stimulation group.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)