Telehealth Mindfulness efter rygsøjleoperation
22. juli 2026 opdateret af: Carrie Brintz, Vanderbilt University Medical Center
Postoperativ Telehealth Mindfulness-intervention efter lændehvirvelsøjlekirurgi: Pilot randomiseret kontrolleret forsøg
Målet med dette kliniske pilotforsøg er at sammenligne to adfærdsmæssige interventioner for patienter, der er ved at komme sig efter lænderygkirurgi for en degenerativ rygsøjletilstand. Undersøgelsen har til formål at besvare følgende spørgsmål:
- Er det muligt og acceptabelt at levere interventionerne og udføre undersøgelsesprocedurerne i denne patientpopulation?
- Er interventionerne til gavn for patienterne med hensyn til smerterelateret, funktionel, opioidbrug og psykosociale resultater 3 og 6 måneder efter operationen, og har den ene intervention mere gavn end den anden?
Deltagerne vil blive bedt om at gøre følgende:
- Udfyld selvrapporteringsspørgeskemaer online før rygsøjleoperation og omkring 2 uger, 3 måneder og 6 måneder efter rygsøjleoperation.
- Gennemfør en sensorisk smerteopgave før rygsøjleoperation og omkring 2 uger, 3 måneder og 6 måneder efter rygsøjleoperation.
- Omkring to uger efter operationen vil deltagerne tilfældigt blive tildelt en af to adfærdsmæssige interventioner - Mindfulness eller Education. Deltagerne vil derefter blive bedt om at deltage i 8 ugentlige sessioner med en studiebehandlingscoach over telesundhed (online med kamera og mikrofon).
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Dette er et randomiseret klinisk pilotforsøg, der sammenligner en telehealth mindfulness-baseret intervention (MBI) med en telehealth education intervention (EDU) for patienter, der kommer sig efter rygsøjlekirurgi. Procedurerne vil være som følger:
- Tilmeld patienter før lændehvirvelsøjlens operation for en degenerativ rygsøjletilstand på Vanderbilt Comprehensive Spine Center. Rekruttering, tilmelding og screening vil ske ved et rutinemæssigt præoperativt klinikbesøg eller over telefonen.
- To uger efter at tilmeldte deltagere har gennemført operationen, vil de blive randomiseret i forholdet 3:2 til henholdsvis MBI eller EDU tilstand. Randomisering vil blive stratificeret ved kronisk præoperativ opioidbrug (ja/nej). Randomiseringstildelingerne vil forblive skjult for alt undersøgelsespersonale indtil randomiseringstidspunktet. Resultatbedømmeren og kirurgiske udbydere vil forblive blinde for deltagernes undersøgelsestilstand.
- Inden for fire uger efter operationen vil deltagerne påbegynde den tildelte intervention. Interventionerne vil bestå af møde med en interventionist til otte ugentlige en-til-en telesundheds-MBI-sessioner over en online telehealth-platform. MBI-sessioner ledes af en klinisk psykolog og vil vare 75 minutter (90 minutter for den første session). EDU-sessioner vil blive ledet af en fysioterapeut og vil vare 30 minutter. Sessioner vil blive lydoptaget og overvåget for troskab.
3) Deltagerne vil gennemføre selvrapporteringsvurderinger online før operation, to uger efter operationen (præ-intervention), tre måneder efter operationen (post-intervention) og 6 måneder efter operationen.
4) Deltagerne vil gennemføre kvantitative sensoriske testvurderinger af smertetolerance, smertetærskel og tidsmæssig summering af smerte før operationen, to uger efter operationen, tre måneder efter operationen og 6 måneder efter operationen.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
67
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Engelsktalende voksne
- 18 år og ældre
- Planlagt til en laminektomi og/eller fusion på Vanderbilt Spine Center
- Planlagt til deres første lændehvirveloperation
- Radiografisk bevis på en degenerativ tilstand, herunder men ikke begrænset til spinal stenose, spondylose med eller uden myelopati og spondylolistese
- Tilstedeværelse af smerter i ryggen og/eller underekstremiteterne, der varer ved i mindst 3 måneder
- Adgang til stabilt internet.
- Kunne deltage i ugentlige fjernsessioner med en studieterapeut i 8 uger efter operationen
Ekskluderingskriterier:
- Mikrokirurgisk teknik som den primære procedure (dvs. isoleret laminotomi eller mikrodiskektomi)
- At blive opereret for den primære indikation af en spinal deformitet
- Under operation sekundært til pseudarthrose, traumer, infektion eller tumor
- Aktuel/historie med en primær psykotisk eller større tankeforstyrrelse eller hospitalsindlæggelse af årsager relateret til psykose (f. Skizofreni, kortvarig psykotisk lidelse, vrangforestillinger). Medicininduceret psykose er ikke udelukkende.
- Diagnose af Alzheimers sygdom eller anden form for demens
- Traumatisk hjerneskade (større end mild sværhedsgrad)
- Anamnese med bipolar lidelse eller dissociativ lidelse
- Brug af aktive stoffer (i sidste måned)
- Aktuelle symptomer på posttraumatisk stresslidelse (PTSD) (i sidste måned)
- Aktive selvmordstanker med hensigt
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Telehealth mindfulness-baseret intervention (MBI)
Otte ugentlige telehealth mindfulness sessioner leveret en-til-en med mindfulness instruktør
|
Telehealth MBI er tilpasset fra Mindfulness-baseret kognitiv terapi for kroniske smerter og består af otte ugentlige 75-minutters individuelle sessioner (90 minutter afsat til den første session) med en mindfulness-interventionist, der leverer interventionen over telehealth (online med lyd- og videokamera ) ud over at patienten modtager deres sædvanlige postkirurgiske behandling.
Deltagerne vil begynde interventionen efter at have afsluttet den 2-ugers postoperative vurdering og inden for 4 uger efter operationen.
Deltagerne vil blive bedt om at øve færdigheder mellem sessionerne cirka 20-40 minutter om dagen.
|
|
Aktiv komparator: Telesundhedsuddannelse (EDU)
Otte ugentlige post-kirurgiske undervisningssessioner leveret en-til-en med fysioterapeut
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Deltagerne vil modtage et skriftligt undervisningshæfte på tidspunktet for randomisering (inden for 2-4 uger efter operationen) og 8 ugentlige telesundhedssessioner af 30 minutter varighed ud over sædvanlig postkirurgisk behandling.
Undervisningsmaterialerne gennemgås individuelt med deltageren under ugentlige telesundhedssessioner (online med lyd- og videokamera) af en fysioterapeut.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Interventionstilfredshed
Tidsramme: 3 måneder efter operationen
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Andel af deltagere, der rapporterer overordnede tilfredshedsniveauer større end eller lig med 7 ud af 10
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3 måneder efter operationen
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Enrollment Rate
Tidsramme: Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
|
Proportion of participants approached who are eligible and enroll in the study
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Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
|
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Participant Study Retention
Tidsramme: 6 months postoperative
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Proportion of participants who complete the study (6 month assessment)
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6 months postoperative
|
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Session Attendance
Tidsramme: Through 3 months postoperative
|
Average proportion of sessions attended out of 8 sessions
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Through 3 months postoperative
|
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Home Practice Completion
Tidsramme: Through 3 months postoperative
|
Average days practiced out of days assigned practice (MBI group only)
|
Through 3 months postoperative
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Smerte gener
Tidsramme: Præoperativ, 2 uger postoperativ, 3 måneder postoperativ, 6 måneder postoperativ
|
Et punkt, der vurderer, hvor generende smerte har været i de sidste 7 dage fra 0 = slet ikke til 4 = ekstremt.
En lavere score indikerer lavere smertegener.
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Præoperativ, 2 uger postoperativ, 3 måneder postoperativ, 6 måneder postoperativ
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Pain Interference Short-form 8a
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Pain Interference short-form 8a from the Patient Reported Outcomes Measurement Information System scale.
Measures interference of pain over the past 7 days.
Consists of 8 items with response options from 1 = not at all to 5 = very much.
The total score is a T-score based on a population with mean score of 50 and standard deviation of 10.
A lower score indicates lower pain interference, or a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Back Pain Intensity
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
1 item assessing back pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off.
Lower scores indicate less pain, or better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Leg Pain Intensity
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
1 item assessing leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off.
Lower scores indicate less pain, or better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Anxiety Short Form 4a
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System.
4 items assessing anxiety symptoms in the past 7 days (e.g.
"I felt fearful") with response options from 1 = never to 5 = always.
The total score is a T-score based on a population with mean score of 50 and standard deviation of 10.
Lower scores represent lower anxiety, a better outcome
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Physical Function
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Physical Function short-form 4a - Patient Reported Outcomes Measurement Information System.
4 items assessing physical function in the past 7 days (e.g.
"Are you able to do chores such as vacuuming or yard work?") with response options from 1 = Unable to do to 5 = Without any difficulty.
The total score is a T-score based on a population with mean score of 50 and standard deviation of 10.
Higher scores represent better physical function, a better outcome
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Depression Short Form 4a
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale.
4 items assessing depressive symptoms over the past 7 days (e.g.
"I felt worthless) with response options from 1 = never to 5 = always.
The total score is a T-score based on a population with mean score of 50 and standard deviation of 10.
A lower score indicates less depression, a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Sleep Disturbance Short Form 4a
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System scale.
4 items assessing sleep disturbance over the past 7 days (e.g.
"I had difficulty falling asleep) with response options from 1 = not at all to 5 = very much (1 item reverse-scored).
The total score is a T-score based on a population with mean score of 50 and standard deviation of 10.
A lower score indicates less sleep disturbance, a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Oswestry Disability Index
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
Assesses impact of pain on level of functioning in 10 areas (e.g.
walking, sleep, social life) with 10 items with response options with scores 0 to 5. Total scores are calculated as a percentage, ranging from 0% to 100%.
Lower scores indicate a lower level of disability due to pain, a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Pain Catastrophizing Scale
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
13 items assessing thoughts and feelings when in pain (e.g.
"I become afraid that the pain will get worse" with response options ranging from 0 = never to 4 = all the time.
Total scores range from 0 to 52 units on the scale.
Lower scores indicate lower pain catastrophizing, a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Pain Self-efficacy Questionnaire
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
10 items assessing confidence in ability to do certain things despite pain (e.g.
"I can enjoy things, despite the pain" with response options 0 = not at all to 6 = completely.
Total scores range from 0 to 60 units on the scale.
Higher scores indicate greater pain self-efficacy, a better outcome.
|
Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Perceived Stress Scale - 4
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
4 items assessing perceived level of stress in the past month (e.g.
"In the last month, how often have you felt that you were unable to control the important things in your life?"), with response options ranging from 0 = never to 4 = very often (2 items reverse-scored).
Total scores range from 0 to 16 units on the scale.
Lower scores indicate lower perceived stress, a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Tampa Scale for Kinesiophobia -13
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
13 items assessing fear of movement (e.g.
"I'm afraid that I might injure myself if I exercise" with response options ranging from 1 = strongly disagree to 4 = strongly agree.
Total scores range from 13 to 52 units on the scale.
Lower scores indicate lower levels of kinesiophobia, a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Five Facet Mindfulness Questionnaire - 15
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Response options range from 1 = never to 5 = always (7 items reverse scored).
Total scores are an average of the sum of all items, ranging from 1 to 5 units on the scale.
Higher scores indicate higher levels of mindfulness, a better outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Number of Participants Indicating They Currently Use Opioids
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
Participants were asked in one item "Are you currently taking an opioid medication?" Response options included "Yes" or "No."
A response of Yes counted as 1 and No counted as 0 when calculating total frequency of participants reporting current opioid use.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Pain Tolerance
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
The duration of time participants tolerated an inflated blood pressure cuff: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the time in seconds at which the participant indicated they could no longer tolerate the stimulus (inflated blood pressure cuff).
Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if reached prior to the participant indicating to stop the task.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Pain Threshold
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
Duration at which participants indicate a stimulus is experienced as painful: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point in seconds at which the stimulus (inflated blood pressure cuff) is first reported by the participant as painful.
Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if participants did not yet indicate that the stimulus was painful.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
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Temporal Summation of Pain
Tidsramme: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
|
Using a punctate stimuli (von frey hairs of 100g and 180g of force to the finger), the difference between reported pain intensity during a single prick and the reported highest pain intensity during repeated brief pricks at a constant intensity.
Pain intensity was measured on a scale of 0 to 100.
The difference score was calculated by subtracting the pain intensity with single prick from the pain intensity with repeated pricks and could range from 0 to 100 units of difference on the pain intensity scale.
Lower values are a more favorable outcome.
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Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Carrie E Brintz, PhD, Vanderbilt University Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. februar 2023
Primær færdiggørelse (Faktiske)
11. juli 2025
Studieafslutning (Faktiske)
11. juli 2025
Datoer for studieregistrering
Først indsendt
27. december 2022
Først indsendt, der opfyldte QC-kriterier
16. januar 2023
Først opslået (Faktiske)
26. januar 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 221711
- K23AT011569 (U.S. NIH-bevilling/kontrakt)
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .