Music Therapy in Patients Undergoing Pancreatic Surgery (MUSIC PUPS): A Mixed Methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Patient reported outcome (PRO) data collection
研究概览
简要总结
Pilot single arm non-randomized trial to determine the feasibility and acceptability of: 1) a tailored music-assisted relaxation and imagery intervention; 2) biological sample collection; and 3) mobile device patient-reported outcome (MDPRO) collection in adults hospitalized for pancreatic surgery experiencing acute pain.
详细描述
After the participant's pancreatic surgery and during their post-surgery hospitalization, the RA will confirm participant eligibility and continued willingness to participate. About an hour later, the RA will return to the participant's room. Before collecting any data, the RA will ask the participant if their pain will permit them to continue and if they would like to proceed. If the participant responds affirmatively, the RA will document this in REDCap and then will proceed to collect baseline (Time 0) patient-reported outcomes (PROs) (i.e., 0-10 ratings of pain, stress, and anxiety) using a REDCap instrument administered on an iPad. The RA will not view the participant's PRO responses. If the participant is currently utilizing a patient-controlled analgesia (PCA) pump, the RA will collect measures of medication usage from the PCA pump. The RA will also collect a peripheral blood sample using a Spot On Sciences HemaSpot-HF. The research team chose the HemaSpot HF because it is an efficient and less invasive means of collecting capillary blood. Using the HemaSpot HF also poses less risk and discomfort to these patients who recently underwent major surgery. Following baseline measure collection, the RA will leave the participant's room.
Following Time 0, the MT-BC will deliver a standardized 30-minute MARI intervention, personalized to the participant's music and imagery preferences. Prior to the intervention, the MT-BC will verify the participant's music and imagery preferences discussed with the RA earlier in the day. During the MARI intervention, the MT-BC will provide live guitar accompaniment personalized to the participant's music preferences and read from a standardized script directing the participant to relax muscles of the body, practice deep breaths, and explore a relaxing place. This intervention will be recorded live and exported to either a study iOS device (e.g., iPod touch, iPhone) programmed to track MARI recording use or uploaded to a Box folder that will be shared with the participant to listen to on their own device. Following the MARI intervention, the MT-BC will briefly process the participant's experience by asking them how the experience was for them and to describe in their own words how they are feeling after the MARI intervention. (please see the attachment "MUSIC PUPS Post MARI Debriefing" for more details). The RA will export the MARI recording to a Box folder that the participant can access using the iOS device.
Immediately following the MARI intervention and post-intervention processing, the MT-BC will leave the participant's room. The RA will then enter the participant's room again. The RA will confirm that the participant is not in too much pain to continue and would like to continue with study procedures, documenting this in REDCap, before collecting post-intervention PROs and peripheral blood smear measures (Time 1). After collecting these measures, the RA will wait in the participant's room for 15 minutes. At 15-minutes post-intervention (Time 2), the RA will again collect PROs and a final peripheral blood smear measure.
Then, the RA will show the participant how to access the MARI recording and enter MDPRO measurements using either the study iOS device or their own device. The RA will instruct the participant to listen to the MARI intervention 3x/day and complete 3 MDPRO measurements each day until discharge. The iOS device will be locked to the participant's tray table to prevent it from being lost or stolen during the participant's hospitalization.
Following the collection of blood samples and PROs, the RA will conduct a review of the participant's medical record to collect data on the participant's demographics, clinical characteristics, and pain medications administered pre-intervention. The RA will enter this data into REDCap. Following sample collection, blood samples will be temporarily stored within the Connor Whole Health research office. Samples will then be shipped within 12 hours to Manoj Bhasin's lab at Emory University for storage and subsequent analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to speak and understand English
- •Patient is scheduled to undergo a Whipple procedure or Distal pancreatectomy at UH Cleveland Medical Center with a standardized pain regimen
- •Patient reports pain intensity of 4/10 or above on day 1 post-surgery
排除标准
- •Subject has a significant visual impairment that has not been corrected
- •Subject has a significant hearing impairment that has not been corrected
- •Subject has a significant cognitive impairment that would prevent subject from participating in the study
结局指标
主要结局
Patient reported outcome (PRO) data collection
时间窗: During the length of patient's hospital stay, up to two weeks
Percent of completed patient reported outcomes surveys
Delivery of a tailored music-assisted relaxation and imagery intervention (MARI)
时间窗: Day 1 of the patients post pancreatic surgery hospital stay
Percent of participants that complete the MARI intervention
Biological sample collection
时间窗: Day 1 of patient's post pancreatic surgery hospital stay
Percent of of viable biological samples collected
次要结局
- Attrition Rate(While the study is active, up to 8 months)
- Enrollment Rate(during the enrollment period of the study, up to two months)
- Rate of MARI recording use(during patient's post pancreatic surgery hospital stay, up to two weeks)
研究者
Samuel Rodgers-Melnick
Principal Investigator
University Hospitals Cleveland Medical Center
