An interventional study of Tens in Postoperative Pain After Cesarean Section, Early Postpartum Mobilization and Postpartum Sleep, sponsored by Inonu University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Inonu University · Not applicable, Interventional, and Treatment
Among 391 studies in Sleep Initiation and Maintenance Disorders with a site in Turkey — 97 open to participants now, 110 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · Turkey.
Among the 391 studies in Sleep Initiation and Maintenance Disorders with a site in Turkey, this one is the 104th largest by planned enrollment of the 310 interventional ones that give a count, is one of 67 that started in 2026, is one of 308 with no phase, reaches primary completion later than 77 of the 109 other live ones, and was the 310th registered.
2,726 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →97 of the 391 studies in Sleep Initiation and Maintenance Disorders with a site in Turkey are open now. Recruiting first, the newest first:
Mersin University · Sites in Turkey
Ages 18+
Dokuz Eylul University · Sites in Turkey
Ages 18+
Gazi University · Sites in Turkey
Ages 50–60 · Women only
Medipol University · Sites in Turkey
Ages 18–65 · Healthy volunteers
Konya Beyhekim Training and Research Hospital · Sites in Turkey
Ages 40–55 · Women only
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
391 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 67 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is close to the median of 68 across 2,353 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 60 across the 310 interventional studies, 120 across the 81 observational. Of the 262 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 391 have an industry lead sponsor. The 10 most frequent:
Inonu University is the lead sponsor of 396 studies on the registry; 96 are open to participants now.
Inonu University has 9 studies filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
34 of the studies in Sleep Initiation and Maintenance Disorders with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07503080Filiz KeskinVirtual Reality (VR) Based Relaxation for Nausea and Comfort in Pregnancy | 2026-11 |
| NCT07768020Munzur UniversityEffect of Eye Mask Use on Sleep Quality and Delirium After CABG Surgery | 2026-11-15 |
| NCT07933263Inonu UniversityThe Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain, Mobilization, and Insomnia Severity After Cesarean Section: A Randomized Controlled Trial | 2026-12 |
| NCT07499245Kafkas UniversityThe Effect of Virtual Reality in Older Adults | 2026-12 |
| NCT07832721Volkan GokmenSleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses | 2026-12 |
Add all 34 to your calendar (.ics) → With an account.
Among the 391 studies in Sleep Initiation and Maintenance Disorders with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is designed using an experimental research model with a pre-test-post-test control group.
The study population consists of women receiving postpartum care following a cesarean section. The sample size was determined through a power analysis using the G*Power software; based on an effect size of d=0.80, an alpha (α) level of 0.05, and a power of 0.95, a minimum of 33 women per group was calculated. Accounting for a potential 10% attrition rate, a total of 72 women-36 in the experimental group and 36 in the control group-will be included in the study. Participants will be assigned to the groups using a simple randomization method.
The experimental group will receive Transcutaneous Electrical Nerve Stimulation (TENS) three times, beginning prior to mobilization. TENS will be applied for 20 minutes at a frequency of 20-40 Hz, a pulse duration of 90-100 µs, and an intensity level tolerable for the participant. The control group will receive no interventions other than routine care.
Data will be collected using a Personal Information Form, the Visual Analog Scale (VAS), the Patient Mobility Scale (PMS), the Observer Mobility Scale (OMS), and the Insomnia Severity Index (ISI). Pre-test measurements will be taken before the first intervention, and post-test measurements will be taken prior to hospital discharge.
Data will be analyzed using the SPSS 29.0 software; descriptive statistics, the chi-square test, and independent and dependent samples t-tests will be employed. A significance level of p\<0.05 will be adopted. Informed written consent will be obtained from the participants, and the principles of the Declaration of Helsinki will be adhered to throughout the study process.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women who are able to communicate verbally and are literate, who have no diagnosed psychiatric conditions, and who experienced no complications related to themselves or their infants during the postpartum period will be included in the study.
Exclusion Criteria:
Women who experienced serious complications (such as hemorrhage, infection, etc.) during or after a cesarean section, or who have for TENS application (e.g., use of a cardiac pacemaker), will be excluded from the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
As part of the study, pre-test data will first be collected from the participants, followed by the initiation of the TENS application protocol. Once the pre-test measurements are completed, the first TENS session will be administered prior to mobilization. Since routine mobilization at the hospital in question is performed at the 6th postoperative hour, the TENS application will begin between the 5th and 6th postoperative hours. In total, three sessions will be conducted; specifically, the TENS sessions will take place between the 5th-6th, 23rd-24th, and 47th-48th postoperative hours.
Device: Tens
No intervention will be applied to the women in the control group.
Experimental Group (TENS Application): Women in the early postoperative period following a cesarean section will receive Transcutaneous Electrical Nerve Stimulation (TENS). Frequency: 20-40 Hz Pulse duration: 90-100 µs Intensity: At a level tolerable for the participant Number of electrodes: 8, placed 2 cm above and below the incision line, as well as over the T10-L1 and S2-S4 dermatomal regions Duration: 20 minutes Number of sessions: 4 (at 5-6, 23-24, and 47-48 hours postoperatively) Control Group: The control group will receive routine postoperative care; no TENS or other interventions will be applied. Characteristics and Distinguishing Features: TENS is employed as a non-pharmacological method for pain management. This intervention is distinguished from other TENS studies by its specific parameters and timing, tailored to the postoperative period following a cesarean section. Objective: To reduce postoperative pain, enhance mobilization, and decrease the severity of inso
Postoperative Pain Severity
Pain intensity will be assessed using the Visual Analog Scale (VAS). The objective is to determine the effectiveness of TENS in reducing postoperative pain following a cesarean section.
Time frame: Before TENS application and before discharge (0-48 hours)
Level of Mobilization (Patient Mobility Scale - PMS)
The levels of pain and exertion experienced by participants while turning in bed, sitting at the edge of the bed, standing up, and walking around the room will be assessed using a five-point Likert-type scale.
Time frame: Before TENS application and before discharge (0-48 hours)
Level of Independence (Observer Mobility Scale - OMS)
The independence levels of the participants will be scored on a scale from 1 (completely independent) to 5 (completely dependent).
Time frame: Before TENS application and before discharge (0-48 hours)
Insomnia Severity (Insomnia Severity Index - ISI)
The severity of insomnia will be assessed using the seven-item Insomnia Severity Index (ISI). The scale measures sleep onset, sleep maintenance, early awakening, sleep satisfaction, impairment in daily functioning, and stress levels.
Time frame: Before TENS application and before discharge (0-48 hours)
Plan to share: No — The individual patient data collected in this study will be used solely for research purposes. The data have been anonymized, and the privacy of the participants will be protected. In accordance with the ethical approval, there are no plans to share these data with other researchers or institutions.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 1,211 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 9 months is below that.
Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →