Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835701
Status:
TERMINATED
Last Update Posted:
2022-07-15
First Post:
2021-04-05
Brief Title:
Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limited staffing support to continue screening and enrollment process
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The intervention of this study is the addition of patient-selected music during IUD insertion procedure Subjects randomized to the music group will choose 10 songs which will be played during the procedure from the time of positioning through completion of IUD insertion and speculum removal Music may be played through a portable speaker in close proximity to the patient or through the patients own headphones if preferred Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure Both control and music groups will otherwise undergo the same standard protocol for IUD insertion in an outpatient clinic setting Total participation is predicted to last approximately 30 minutes
Subjects in both control and intervention groups will undergo the same assessment of pain during IUD insertion using the 100-mm visual analog scale VAS This will be administered at 8 points during the procedure All subjects will also answer the same 5-question satisfaction survey following IUD insertion Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study
Subjects in both control and intervention groups will undergo the same assessment of pain during IUD insertion using the 100-mm visual analog scale VAS This will be administered at 8 points during the procedure All subjects will also answer the same 5-question satisfaction survey following IUD insertion Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study
Detailed Description:
This is a prospective two-center randomized controlled trial evaluating whether music reduces pain and improves satisfaction during IUD insertion Computer-generated randomization assignments will allocate subjects to either music or standard protocol groups 40 music and 40 control designations will be allocated to both sites and all designations will be block-stratified into 10 blocks each containing 4 controls and 4 intervention music subjects This will ensure there are close to equal numbers of subjects in both groups if recruitment is halted before the minimum of 80 patients are enrolled Assignments are available in a read-only document accessible by all co-investigators at the time of enrollment and randomization
Subjects randomized to the music group will choose 10 songs which will be played during the procedure from the time of positioning through completion of IUD insertion and speculum removal Music may be played through a portable speaker in close proximity to the patient or through the patients own headphones if preferred Both control and music groups will otherwise undergo the same standard anticipatory guidance and protocol for IUD insertion in an outpatient clinic setting Total participation is predicted to last approximately 30 minutes as is standard for an appointment for IUD insertion Study subjects will not interact with other participants
Patients in both control and intervention groups will undergo intrauterine device IUD insertion Pain will be assessed using a 100-mm visual analog scale VAS at 8 points during the procedure including 1 anticipated pain 2 baseline pain prior to IUD insertion 3 after speculum placement 4 on tenaculum application 5 on uterine sounding 6 at IUD insertion 7 after speculum removal and 8 5 minutes following the procedure Patients will also answer a brief 5-question satisfaction survey following IUD insertion Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study
VAS scores will be recorded by the attending physician or co-investigator as they will reliably note when each step of the procedure occurs and pain should be assessed They will present the 100mm visual analog scale VAS to the patient at each of the 8 points of the procedure and the patient will mark their pain score Scores will be measured and documented by a single co-investigator to eliminate bias or differences in measurement
VAS scores will be analyzed separately for each of the 8 distinct points described during the IUD insertion procedure Differences between the intervention music and control groups will be assessed using a 005 level Wilcoxon ranksum test A significant difference in pain will be noted if at least a 20 mm difference in VAS pain score exists between the two groups at any point of the procedure when VAS score is collected
The aim of this study is to determine if music chosen by the patient and played during IUD insertion leads to lower pain scores and improved patient satisfaction with the procedure
Subjects randomized to the music group will choose 10 songs which will be played during the procedure from the time of positioning through completion of IUD insertion and speculum removal Music may be played through a portable speaker in close proximity to the patient or through the patients own headphones if preferred Both control and music groups will otherwise undergo the same standard anticipatory guidance and protocol for IUD insertion in an outpatient clinic setting Total participation is predicted to last approximately 30 minutes as is standard for an appointment for IUD insertion Study subjects will not interact with other participants
Patients in both control and intervention groups will undergo intrauterine device IUD insertion Pain will be assessed using a 100-mm visual analog scale VAS at 8 points during the procedure including 1 anticipated pain 2 baseline pain prior to IUD insertion 3 after speculum placement 4 on tenaculum application 5 on uterine sounding 6 at IUD insertion 7 after speculum removal and 8 5 minutes following the procedure Patients will also answer a brief 5-question satisfaction survey following IUD insertion Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study
VAS scores will be recorded by the attending physician or co-investigator as they will reliably note when each step of the procedure occurs and pain should be assessed They will present the 100mm visual analog scale VAS to the patient at each of the 8 points of the procedure and the patient will mark their pain score Scores will be measured and documented by a single co-investigator to eliminate bias or differences in measurement
VAS scores will be analyzed separately for each of the 8 distinct points described during the IUD insertion procedure Differences between the intervention music and control groups will be assessed using a 005 level Wilcoxon ranksum test A significant difference in pain will be noted if at least a 20 mm difference in VAS pain score exists between the two groups at any point of the procedure when VAS score is collected
The aim of this study is to determine if music chosen by the patient and played during IUD insertion leads to lower pain scores and improved patient satisfaction with the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None