Brief Postoperative Pain Management Intervention: Meaning Making Amendment
23. juni 2026 oppdatert av: Adam Hanley, University of Utah
Brief Postoperative Pain Management Intervention for Knee and Hip Replacement Patients: Meaning Making Amendment
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
576
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Adam Hanley
- Telefonnummer: 850-645-9557
- E-post: adam.hanley@utah.edu
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112
- University of Utah
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥18,
- Underwent joint arthroplasty of the knee or hip
Exclusion Criteria:
- Inability to read English
- Cognitive impairment preventing completion of study procedures
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Meaning Making Questions
|
Participants 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.
|
|
Aktiv komparator: Implementation Questions
|
Participants 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Unpleasantness
Tidsramme: Immediately before to after 5-minute audio recording
|
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.
|
Immediately before to after 5-minute audio recording
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity
Tidsramme: Immediately before to after 5-minute audio recording
|
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.
|
Immediately before to after 5-minute audio recording
|
|
Change in Pain Medication Desire
Tidsramme: Immediately before to after 5-minute audio recording
|
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.
|
Immediately before to after 5-minute audio recording
|
|
Change in Anxiety
Tidsramme: Immediately before to after 5-minute audio recording
|
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.
|
Immediately before to after 5-minute audio recording
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Tidsramme: During the 6 weeks prior to surgery and at the 2-, 6-, and 12-week outpatient follow-up appointments
|
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.
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During the 6 weeks prior to surgery and at the 2-, 6-, and 12-week outpatient follow-up appointments
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
30. juni 2027
Studiet fullført (Antatt)
30. september 2027
Datoer for studieregistrering
Først innsendt
23. juni 2026
Først innsendt som oppfylte QC-kriteriene
23. juni 2026
Først lagt ut (Faktiske)
30. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB_00178929 AM_00056057
Legemiddel- og utstyrsinformasjon, studiedokumenter
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