About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Active rocking in a rocking chair
BehavioralParticipants will actively rock 3 times per day for 30 minutes in a rocking chair
Sitting upright in a stationary chair
BehavioralParticipants will sit upright in a stationary chair 3 times per day for 30 minutes
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
Secondary outcomes
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.
Total participants reporting Gas/bloating via PROMIS v1.1 GI Gas and Bloating 13A
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.
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.
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.
Locations
Sponsors and contacts
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University of Missouri, Kansas City
Lead sponsor
Sigma-Tau Research, Inc.
Collaborator
Association of Rehabilitation Nurses
Collaborator
This trial is not recruiting at the moment. You can still explore other options: