Pain control using novel TENS device in patients post transverse suprapubic gynaecology surgeries Urological and Genital Diseases
Conditions
Interventions
Current interventions as of 13/04/2026:
Eligible participants will be equally divided into 2 groups through a computer-generated randomisation sequence prepared before the start of the study. The gr
Sponsors
Obstetrics & Gynaecology Department University Malaya
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old 2. Patients undergoing elective or emergency gynaecology surgery (eg, myomectomy, hysterectomy, ovarian/ tubal surgeries) via transverse suprapubic incision under general anaesthesia 3. Able to communicate in English or Malay 4. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindications to TENS (pacemaker, skin lesions) 2. Chronic pain on regular opioids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score on movement measured using a 0-10 Numerical Rating Scale (11-point NRS) immediately, 1-, 2- and 4- hours after application of active-TENS vs sham-TENS sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 13/04/2026: 1. Repeated measures of the variance analysis for the serial pain scores across active-TENS vs sham-TENS sessions 2. Comparison of pain score on movement- immediately, 1-, 2- and 4- hours after application of intervention or sham control sessions of 15 minutes after the first session only (across randomised arms) 3. Repeated measures of the variance analysis of the serial pain scores on movement (across randomised arms) 4. Identical analyses for similarly recorded blood pressure and pulse- immediately, 1-, 2- and 4- hours after active-TENS vs sham-TENS sessions 5. Satisfaction score with the intervention immediately after the sessions, using 11 points NRS (higher score greater satisfaction) 6. Opioid consumption after trial intervention _____ Previous key secondary outcome(s): 1. Variance in serial pain scores between active TENS and sham TENS sessions, measured using data from the repeated measurement of pain scores at one timepoint 2. Pain score on movement will be measured at specified time points following a single 15-minute session of active-TENS or sham-TENS. Comparisons will be made across randomised arms at one timepoint. 3. Pain score on movement, measured using repeated measures ANOVA across all treatment sessions at one timepoint 4. Blood pressure and pulse, measured using standard clinical methods and analysed using repeated measures at 0, 1, 2, and 4 hours after active-TENS or sham-TENS sessions 5. Satisfaction with intervention, measured using an 11-point NRS immediately after each session 6. Opioid consumption, measured using medication usage records after application of active-TENS or sham-TENS device | — |
Countries
Malaysia
Contacts
Public ContactLavina Belayutham
Outcome results
None listed