MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.
ConditionIntrauterine Device
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCairo University
About this trial
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.
Disqualifiers
a prior pregnancy greater than 20 weeks of duration
currently pregnant or were pregnant within 6 weeks of study entry
had a prior attempted or successful IUD insertion
had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD active vaginitis or cervicitis
Trial design
Design model
Parallel
Treatments tested in this trial
music
Procedure/Surgerymusic will be played during the copper IUD insertion
no music
Procedure/SurgeryIUD insertion will be done as usual without music
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: music groupExperimental treatment 1 intervention
Group B: no-music groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
pain during IUD insertion
pain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt
Time frame
5 minutesSecondary outcomes
1
anxiety during IUD insertion
anxiety will be measured by the 10 cm like visual analog scale where 0 denotes no anxiety, and 10 denotes maximal anxiety
Time frame
5 minutesLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: