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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dilara Özen Oruk, PhD
- 전화번호: +902522112072
- 이메일: dilaraozen@mu.edu.tr
연구 장소
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Muğla, 터키 (Türkiye), 48000
- 모병
- Menteşe State Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Pain Intensity at Rest
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Postpartum Comfort
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Association Between Psychological Symptoms and Change in Pain Intensity
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Dilara Özen Oruk, PhD, Muğla Sıtkı Koçman University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MSKU-CS-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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