A study evaluating a focused electrical nerve stimulation device for pain relief in women after vaginal childbirth

Study of a novel focused transcutaneous nerve stimulation device for perineal pain in women undergoing vaginal delivery: a blinded randomised sham controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15715807

Enrollment

100

Registered

2026-05-20

Start date

2026-05-25

Completion date

Unknown

Last updated

2026-06-08

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

Conditions

Perineal pain in women undergoing vaginal delivery Pregnancy and Childbirth

Interventions

At the beginning of each trial intervention session: 1. Participants will receive a briefing that some electrotherapies do not generate sensations. 2. Participants will receive TENS at a starting in

Eligibility

Sex/Gender

Female

Age

18 Years to 47 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Singleton pregnancy 3. Term gestation =37 weeks 4. Viable pregnancy 5. Cephalic presentation 6. Vaginal delivery 7. Perineal injury requiring repair 8. Initial intervention within 2 hours of completion of repair

Exclusion criteria

Exclusion criteria: 1. Epidural analgesia 2. Chronic pain conditions requiring ongoing analgesic therapy 3. Obstetric anal sphincter injury 4. Contraindications to TENS (e.g., cardiac pacemaker, skin lesions at electrode sites)

Countries

Malaysia

Contacts

Public ContactJun Yan Tay

yantay@ummc.edu.my+44 (0)165235158

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026