Postoperative Pain After Cesarean Section
Conditions
Keywords
Transcutaneous Electrical Nerve Stimulation, TENS, Interferential Current Therapy, Cesarean Delivery, Postpartum Comfort, Acute Postoperative Pain, Nonpharmacological Pain Management
Brief summary
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.
Detailed description
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.
Interventions
DEVICEConventional TENS
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 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.
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.
Sponsors
Dilara Özen Oruk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to the conventional TENS, interferential current therapy, or placebo stimulation group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity at Rest | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postpartum Comfort | 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. |
| Treatment Satisfaction | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTDilara Özen Oruk, PhD
PRINCIPAL_INVESTIGATORDilara Özen Oruk, PhD
Muğla Sıtkı Koçman University
Outcome results
None listed