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The Clinical Study of Transcutaneous Wrist-Ankle Nerve Electrical Stimulation in Alleviating Uterine Contraction Pain

Transcutaneous Electrical Nerve Stimulation (TENS) of the Wrist and Ankle for Alleviating Uterine Contraction Pain: A Multi-center, Prospective, Randomized, Double-blind, Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000808
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum uterine contractions pain

Interventions

Experimental Group:Adjust the current intensity to the maximum tolerable level for the patient (above the sensory threshold, strong tingling sensation without pain), and maintain effective stimulation
Control Group:The device outputs perceptible current within the first 30 seconds (to reassure the patient that treatment has begun), and subsequently automatically reduces to below the minimum effecti

Sponsors

First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Primiparous women who delivered vaginally or by cesarean section at 37-42 weeks of gestation; 2) Aged 18-45 years; 3) Singleton pregnancy and live birth; 4) Intend to breastfeed postpartum; 5) No severe abnormalities in blood tests, heart, liver, or kidney functions; 6) American Society of Anesthesiologists (ASA) physical status classification of I or II; 7) Voluntarily participate in this study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Severe pregnancy complications (e.g., eclampsia, placental abruption); 2) History of pacemaker implantation or epilepsy; 3) Long-term use of analgesics or history of chronic pain; 4) Depression scale, anxiety scale =50 points (self-rated anxiety scale/self-rated depression scale 70 points is severe anxiety); 5) Coexistence of other pain-related diseases; 6) Skin damage, dermatitis, infection, or sensory abnormalities in the electrode patch application area; 7) Known allergy to electrical stimulation or other contraindications for TENS therapy; 8) Presence of cognitive impairment or mental illness, inability to judge one's own pain and general condition, and inability to cooperate with study assessments; 9) Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Incidence rate of moderate to severe uterine contractions pain (Visual Analog Scale (VAS) =4) on Postpartum Day 1 (0-24 hours);

Secondary

MeasureTime frame
Incidence rate of moderate to severe uterine contractions pain on Postpartum day 2 (24-48 hours);Incidence rate of moderate to severe uterine contractions pain on the third postpartum day (48-72 hours);Uterine contraction pain level;Frequency of uterine contractions;Duration of uterine contractions pain;Incision pain level;First rescue analgesia time;Rescue Analgesic Drug Usage;Rescue Analgesics Utilization Rate;Depression Status (EPDS);Anxiety Condition (PRAQ-R2);Sleep Quality (LSEQ);Postpartum Recovery Quality (QoR-15);Postpartum mobility within 72 hours;Breastfeeding status;Parent-child relationship;Lochia condition;Uterine involution status;

Countries

China

Contacts

Public ContactJin Yu

First Affiliated Hospital of Naval Medical University

15821627980@163.com15821627980

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026