Feasibility and Acceptability of the Impact of a Rocking Chair Intervention on Recovery Compared to Standard Care of Stationary Chair on Older Adults After Elective Orthopedic Hip Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Number of participants that enroll and complete study assessed by Feasibility Participant Questionnaire (developed by investigators)
研究概览
简要总结
Feasibility and acceptability randomized controlled trial exploring the use of a rocking chair after a total hip arthroplasty in adults who are aged 65 or older. Primary aims include its feasibility and acceptability; exploratory aims include the impact of rocking on pain, gastrointestinal effects, anxiety, ambulation, and additional healthcare visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to undergo an elective primary total hip arthroplasty
- •Weigh less than 163kg (limit of rocking chair)
- •Able to consent
- •Able to rock with at least one leg
排除标准
- •Unable to sit in a chair for at least 30 minutes at a time
- •Hospitalized more than 24 hours after surgery
- •Cannot read and understand the English language
- •Planned disposition to rehabilitation facility or skilled nursing facility
- •Known vestibular dysfunction (such as Menieres, traumatic brain injury, vertigo)
研究组 & 干预措施
Attention Control Group
Sitting upright in stationary chair
干预措施: Sitting upright in a stationary chair (Behavioral)
Intervention Group
Rocking chair intervention
干预措施: Active rocking in a rocking chair (Behavioral)
结局指标
主要结局
Number of participants that enroll and complete study assessed by Feasibility Participant Questionnaire (developed by investigators)
时间窗: From enrollment to 31-day follow-up
Feasibility of active rocking post-operative measured by total number of participants enrolled, total percentage and number completing the study, and percent of missing data. A higher percent of missing data is a negative outcome.
Total participants reporting acceptability of rocking or sitting as measured by Acceptability for Participants Questionnaire
时间窗: From enrollment to 31-day follow-up
Acceptability of rocking or sitting after hip arthroplasty indicated by score on domains of affective, perceived effectiveness, intervention coherence, ethicality, burden, opportunity costs, self-efficacy likert scales from 1-4 (Not at all, a little, somewhat, very much). Scores from each domain are combined and summed to determine a single acceptability score (higher scores equate to higher acceptability of the intervention).
次要结局
- Total participants indicating Nausea using the PROMIS Scale v1.0 GI Nausea and Vomiting 4A(From surgery to 31-day follow-up)
- Total participants reporting Gas/bloating via PROMIS v1.1 GI Gas and Bloating 13A(From surgery to end of 31-day follow-up)
- Total participants reporting Daily pain assessed by PROMIS v2.0 pain intensity 3A(From surgery to end of 31-day follow-up)
- Total amount of participants' Daily Ambulation as measured using steps via activPAL4pro accelerometer(After surgery and up to 7 days post-surgery)
- Total amount of participants' Daily anxiety measured using the Anxiety subscale of the Neuro-QoL Hospital Anxiety and Depression Scale(From enrollment through 31-day follow-up)
- Participants' self-reported Additional healthcare visits since their surgery, as assessed via phone call at 31-days post-surgery(From surgery until 31-day follow-up)
- Total participants indicating Nausea using the PROMIS Scale v1.0 GI Nausea and Vomiting 4A(From surgery (Day 1 of the study) to 31-day follow-up)
- Total participants reporting Gas/bloating via PROMIS v1.1 GI Gas and Bloating 13A(From surgery (Day 1 of the study) to end of 31-day follow-up)
- Total participants reporting Daily pain assessed by PROMIS v2.0 pain intensity 3A(From surgery (Day 1 of the study) to end of 31-day follow-up)
- Total amount of participants' Daily Ambulation as measured using steps via activPAL4pro accelerometer(After surgery (Day 1 of the study) and up to 7 days post-surgery)
- Participants' self-reported Additional healthcare visits since their surgery, as assessed via phone call at 31-days post-surgery(From surgery (Day 1 of the study) until 31-day follow-up)
研究者
Matthew Chrisman
Associate Professor
University of Missouri, Kansas City