Distraction using sound and performance of a simple mental task compared to local anesthetic jelly application during intrauterine device insertion to reduce pain

Sound combined with mental task versus cervical application of lignocaine jelly for pain relief during intrauterine device insertion: a randomized controlled trial

Registry ID
ISRCTN16954929
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University of Malaya
Enrollment
100
Start date
2026-08-01
Completion date
2027-08-01
Last update
2026-08-17

Conditions

Summary

Intrauterine device placement as medically indicated

Detailed description

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 explained that after the cervix is exposed with the Cusco speculum, a recording of rain sounds will be played and every 5 seconds a number will be mentioned. The participants will be instructed to listen and focus on the rain sounds and to retain in their memory the largest number mentioned in the series until the end of the procedure. Three minutes into the recording to allow the recording’s effect to take place, the usual standard IUD insertion process will then start. For participants assigned to intervention of Lignocaine 2% jelly applied to the cervix, the process will be explained to them after the opening of the opaque envelope allocated to them. It will be explained that after the cervix is exposed with the Cusco speculum, Lignocaine 2% jelly will be applied under direct vision to the surface of the external opening of the cervical canal. Three minutes after the start of application of lignocaine jelly to allow jelly’s effect to take place, the usual standard IUD insertion process will then start. All participants will be prepared for IUD insertion according to local protocol. The bivalve vaginal speculum (Cusco) will be used to expose the cervix. Standard protocol for IUD insertion(1, 2): 1. After obtaining inform consent, patient will be positioned in lithotomy position. 2. A bimanual examination performed to determine whether the uterus is anteverted or retroverted. 3. Cusco speculum inserted vaginally to identify the cervix. Cervix and vaginal fornices are cleaned. 4. Depending on cervical findings through the Cusco speculum, the cervical lip maybe grasped using tenaculum and gentle traction applied to straighten the cervical canal and uterine cavity. However, if cervical and bimanual examination findings are favourable, tenaculum use may not be necessary.

Interventions

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

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)

Locations

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