Comparison of the Effects of Interferential Current and Transcutaneous Electrical Nerve Stimulation on Pain Following Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity at Rest
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Conventional TENS
Participants will receive one 30-minute session of conventional transcutaneous electrical nerve stimulation following cesarean section.
干预措施: Conventional Transcutaneous Electrical Nerve Stimulation (Device)
Interferential Current Therapy
Participants will receive one 30-minute session of interferential current therapy following cesarean section.
干预措施: Interferential Current Therapy (Device)
Placebo Stimulation
Participants will receive one 30-minute session of placebo electrical stimulation following cesarean section.
干预措施: Placebo Electrical Stimulation (Device)
结局指标
主要结局
Change in Pain Intensity at Rest
时间窗: 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.
次要结局
- 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)
研究者
Dilara Özen Oruk
Research Assistant, PhD
Muğla Sıtkı Koçman University