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

ConditionPostoperative Pain After Cesarean Section

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-40

SponsorDilara Özen Oruk

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.

Treatment groups

54 Participants

are divided into 3 treatment groups

Group A: Conventional TENSActive comparator 1 intervention

Group B: Interferential Current TherapyExperimental treatment 1 intervention

Group C: Placebo StimulationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline, immediately after the 30-minute intervention, 1 hour after the intervention, and 2 hours after the intervention

Secondary outcomes

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.

Time frame

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.

Time frame

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

Other outcomes

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.

Time frame

From baseline to 2 hours after the intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dilara Özen Oruk

Lead sponsor

Muğla Sıtkı Koçman University

Sponsor institution

Source ClinicalTrials.gov

Apply now