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This study is to determine if patients following prolapse repair including vaginal vault suspension have decreased pain measured via a visual analog scale (VAS) on postoperative day one and just prior to discharge when exposed to the diad of music and positive images compared to patients receiving standard care.
Over the past decade, interest has grown in improving the patient experience. As part of this movement, studies have sought to evaluate the mechanisms by which the postoperative environment affects a patient's outcome and perception of healing.
Literature review reveals efforts by both medical and design teams towards improving the experience of the patient and developing an environment that promotes healing. Changes to the physical environment have been shown to have an impact on satisfaction. These parameters have included music and art. Considering the effort that is now going into improving the patient experience and developing this theory of healing spaces, there has yet to be a randomized controlled trial evaluating these alternative therapies in the urogynecologic patient population. Although each of these modalities appears beneficial, we believe that a combination of these would be even more useful. Indeed, these treatments are also relatively easy to implement without undue cost or burden to the hospital. This study seeks to determine the influence of applying music and art to the post operative environment for patients recovering from major urogynecologic surgery on pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care. |
|
| Control group | No Intervention | Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| music and positive images | Other | The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Score for Pain | VAS score for pain administered following breakfast on post-operative day one. The VAS was100 millimeter (mm) scale with 'no pain' on the far left represented as 0 mm and 'most pain' on the far right equating to 100 mm. | following breakfast on Post-operative day one |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Pauls, MD | TriHealth - Cincinnati Urogynecology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care. music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room. |
| FG001 | Control Group | Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care. music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) Score for Pain | VAS score for pain administered following breakfast on post-operative day one. The VAS was100 millimeter (mm) scale with 'no pain' on the far left represented as 0 mm and 'most pain' on the far right equating to 100 mm. | Posted | Median | Full Range | millimeter (mm) | following breakfast on Post-operative day one |
|
2 week post-op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care. music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Pauls, MD | TriHealth Inc. | 513-463-4300 | Rachel_Pauls@trihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Nov 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| No primary outcome |
|
| BG001 | Control Group | Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment. |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Control Group | Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment. | 0 | 46 | 0 | 46 | 0 | 46 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |