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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Dilara Özen Oruk, PhD
- Telefoonnummer: +902522112072
- E-mail: dilaraozen@mu.edu.tr
Studie Locaties
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Muğla, Turkije (Türkiye), 48000
- Werving
- Menteşe State Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Conventional TENS
Participants will receive one 30-minute session of conventional transcutaneous electrical nerve stimulation following cesarean section. |
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. |
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Experimenteel: Interferential Current Therapy
Participants will receive one 30-minute session of interferential current therapy following cesarean section. |
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.
Andere namen:
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Placebo-vergelijker: Placebo Stimulation
Participants will receive one 30-minute session of placebo electrical stimulation following cesarean section. |
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Pain Intensity at Rest
Tijdsspanne: Baseline, immediately after the 30-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Postpartum Comfort
Tijdsspanne: Baseline and 2 hours after the intervention
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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
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Treatment Satisfaction
Tijdsspanne: Immediately after the intervention, 1 hour after the intervention, and 2 hours after the intervention
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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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Association Between Psychological Symptoms and Change in Pain Intensity
Tijdsspanne: From baseline to 2 hours after the intervention
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dilara Özen Oruk, PhD, Muğla Sıtkı Koçman University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MSKU-CS-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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