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| Name | Class |
|---|---|
| Sigma-Tau Research, Inc. | INDUSTRY |
| Association of Rehabilitation Nurses | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Rocking chair intervention |
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| Attention Control Group | Active Comparator | Sitting upright in stationary chair |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rocking in a rocking chair | Behavioral | Participants will actively rock 3 times per day for 30 minutes in a rocking chair |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that enroll and complete study assessed by Feasibility Participant Questionnaire (developed by investigators) | 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. | From enrollment to 31-day follow-up |
| Total participants reporting acceptability of rocking or sitting as measured by Acceptability for Participants Questionnaire | 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). | From enrollment to 31-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Total participants indicating Nausea using the PROMIS Scale v1.0 GI Nausea and Vomiting 4A | Participants indicate Daily nausea assessment on 5-point Likert scale (never, rarely, sometimes, often, always). Higher scores indicate more Nausea. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia Hopper, MSN | Contact | 816-235-5700 | amhkk9@umkc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Chrisman, PHD | University of Missouri, Kansas City | Study Chair |
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Will provide de-identified data to other researchers if a reasonable request is made
Start date: March 2026 End date: up to 7 years after study ends
Study investigators will be able to access the IPD after it has been de-identified. They will access via password protected files.
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| ID | Term |
|---|---|
| D000077708 | Sitting Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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2 groups randomized 1x1
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| Sitting upright in a stationary chair | Behavioral | Participants will sit upright in a stationary chair 3 times per day for 30 minutes |
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Participants reporting Daily gas/bloating assessment on 5-point Likert scale (not at all, a little bit, somewhat, quite a bit, very much). Higher scores indicate more daily gas/bloating. |
| 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 | Participants reporting Daily pain assessment on 5-point likert scale (no pain, mild, moderate, severe, very severe). Higher scores equate to more daily pain experienced. | 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 | The amount of participants' Daily ambulation will be assessed with the amount of steps taken per day using the triaxial accelerometer activPAL4pro. More steps per day equates to greater ambulation. | After surgery (Day 1 of the study) 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 | The participants will report their Daily anxiety assessment using the Anxiety subscale of the Neuro-QoL Hospital Anxiety and Depression Scale, which assesses self-reported fear, worry, tension, and nervousness and will be scored with a T-score with higher scores indicating more anxiety. The scores range from 0-3 (not at all, not often, sometimes, most of the time). | 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 | The total number of Additional healthcare visits will be assessed via phone call at 31-days post-surgery using the investigator-developed question: Have you been hospitalized since you have been discharged from your hip surgery? | From surgery (Day 1 of the study) until 31-day follow-up |