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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Dilara Özen Oruk, PhD
- Telefonnummer: +902522112072
- E-post: dilaraozen@mu.edu.tr
Studiesteder
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-
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Muğla, Tyrkia (Türkiye), 48000
- Rekruttering
- Menteşe State Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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. |
|
Eksperimentell: 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.
Andre navn:
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Placebo komparator: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Pain Intensity at Rest
Tidsramme: Baseline, immediately after the 30-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Postpartum Comfort
Tidsramme: Baseline and 2 hours after the intervention
|
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
Tidsramme: Immediately after the intervention, 1 hour after the intervention, and 2 hours after the intervention
|
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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Association Between Psychological Symptoms and Change in Pain Intensity
Tidsramme: From baseline to 2 hours after the intervention
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Dilara Özen Oruk, PhD, Muğla Sıtkı Koçman University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MSKU-CS-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
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