Brief Postoperative Pain Management Intervention: Meaning Making Amendment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
This single-site, two-arm, parallel-group randomized controlled trial will enroll adults undergoing total knee or hip replacement surgery. Two days after surgery, participants will complete a brief guided mindful breathing practice delivered by text message and will then be randomized to receive either personalized meaning-making questions or implementation-focused questions. The trial will evaluate whether personalized meaning-making questions enhance the clinical effects of the mindfulness practice on acute pain, pain unpleasantness, anxiety, desire for pain medication.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18,
Underwent joint arthroplasty of the knee or hip
Disqualifiers
Inability to read English
Cognitive impairment preventing completion of study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness + Meaning Making Questions
BehavioralParticipants randomized to this arm will receive a brief, text-message-delivered mindfulness intervention two days after total knee or hip replacement surgery. The intervention consists of a 5-minute guided mindful breathing practice that begins with visually paced breathing and then transitions to audio-guided mindful awareness of the breath. Immediately afterward, participants will answer personalized meaning-making questions designed to help them reflect on what stood out during the practice and how that experience related to their pain, relaxation, or coping.
Mindfulness + Implementation Questions
BehavioralParticipants randomized to this arm will receive a brief, text-message-delivered mindfulness intervention two days after total knee or hip replacement surgery. The intervention consists of a 5-minute guided mindful breathing practice that begins with visually paced breathing and then transitions to audio-guided mindful awareness of the breath. Immediately afterward, participants will answer two implementation-focused questions about how the intervention could best be delivered or used in postoperative care, such as preferred timing, length, or mode of delivery.
Treatment groups
576 Participants
are divided into 2 treatment groupsGroup A: Meaning Making QuestionsExperimental treatment 1 intervention
Group B: Implementation QuestionsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Unpleasantness
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not unpleasant, 10=The most unpleasant pain imaginable) numeric rating scale. Higher scores indicate greater pain unpleasantness.
Time frame
Immediately before to after 5-minute audio recordingSecondary outcomes
1
Change in Pain Intensity
Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=No pain, 10=Pain as bad as you can imagine) numeric rating scale. Higher scores indicate greater pain intensity.
Time frame
Immediately before to after 5-minute audio recording2
Change in Pain Medication Desire
Single item assessing pain unpleasantness ("How much do you want to take pain medicine?") scored on an 11-point (0=Not at all, 10=Extremely) numeric rating scale. Higher scores indicate greater desire for pain medicine.
Time frame
Immediately before to after 5-minute audio recording3
Change in Anxiety
Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Anxiety as bad as you can imagine) numeric rating scale. Higher scores indicate greater anxiety.
Time frame
Immediately before to after 5-minute audio recordingOther outcomes
1
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score reflects better physical functioning.
Time frame
During the 6 weeks prior to surgery and at the 2-, 6-, and 12-week outpatient follow-up appointmentsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: