Intrauterine device placement as medically indicated Urological and Genital Diseases
Conditions
Interventions
For participants assigned to intervention of sound combined with mental task, the process required will be explained to them after the opening of the opaque envelope allocated to them. It will be expl
Sponsors
University of Malaya
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Scheduled for IUD insertion as medically indicated 2. Premenopausal adults (18 years old and above) 3. Not pregnant (no unprotected sexual intercourse since last normal menstrual period)
Exclusion criteria
Exclusion criteria: 1. Suspicion of pregnancy 2. Current diagnosis of vaginal or pelvic infection 3. Neuropathic disabled patients from below waist 4. Known structural abnormality of the uterus 5. Lignocaine allergy 6. Usage of analgesics within 24 hours of the procedure 7. History of ectopic pregnancy 8. Unexplained abnormal vaginal bleeding 9. Contraindication to intrauterine device or system 10. Lack of capacity to provide consent for any reason (e.g., language difficulties, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum (peak) pain score experienced during IUD insertion measured using Numerical Rating Scale (0 no pain to 10 worst pain imaginable) at within 5 minutes of the end of the procedure;Average pain during IUD insertion measured using Numerical Rating Scale (0 no pain to 10 worst pain imaginable) at within 5 minutes after completion of the procedure;Patient satisfaction with allocated intervention measured using Numerical Rating Scale (0 completely dissatisfied to 10 completely satisfied) at 15 minutes after completion of the procedure;Current lower abdomen-perineum pain measured using Numerical Rating Scale (0 no pain to 10 worst pain imaginable) at 15 minutes after completion of the procedure;IUD insertion success measured using clinical assessment and procedure record (successful placement of IUD versus unsuccessful or abandoned insertion) at completion of the procedure;IUD insertion time measured using procedure timing recorded using clinical procedure records or stopwatch (time from start of allocated intervention to removal of Cusco speculum) at during the procedure, recorded at completion or abandonment;Post-procedure symptoms including dizziness, headache, vaginal irritation, nausea, palpitations, shortness of breath, and tremor measured using symptom questionnaire with Numerical Rating Scale and yes or no responses at 15 minutes after completion of the procedure and at end of data collection | — |
Countries
Malaysia
Contacts
Public ContactPunitha Subramaniam
Outcome results
None listed