Postoperative Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERmusic 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.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18-85 years of age * English speaking * Undergoing surgery for pelvic organ prolapse to include an apical vaginal vault suspension by a physician at Cincinnati Urogynecology Associates, TriHealth * Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy will be included * Ability to complete the questionnaires and provide consent * Willingness to listen to music at the minimum recommended time intervals
Exclusion criteria
* Unwillingness to participate in the study * Physical or mental impairment that would affect the subject's ability to utilize the modified environment such as deafness, blindness or dementia * Patients who take daily narcotics or NSAIDS * Patients with history of Drug or Alcohol Abuse * Patients with chronic pain syndromes * Non English speaking * Patients that do not undergo a vaginal apical suspension procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Score for Pain | following breakfast on Post-operative day one | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Control Group Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment. | 46 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No primary outcome | 12 | 22 |
| Overall Study | not having correct procedure | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 9.4 | 63.6 years STANDARD_DEVIATION 9.6 | 63.8 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black/African American | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 44 participants | 43 participants | 87 participants |
| Region of Enrollment United States | 46 participants | 46 participants | 92 participants |
| Sex: Female, Male Female | 46 Participants | 46 Participants | 92 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
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.
Time frame: following breakfast on Post-operative day one
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Visual Analog Scale (VAS) Score for Pain | 28.0 millimeter (mm) |
| Control Group | Visual Analog Scale (VAS) Score for Pain | 24.5 millimeter (mm) |
p-value: 0.57Wilcoxon (Mann-Whitney)