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A brief mind-body i...
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Gaffney, Christopher D.
(författare)
A brief mind-body intervention to reduce pain and anxiety during prostate needle biopsy: a clinically integrated randomized controlled trial with 2-staged consent
- Artikel/kapitelEngelska2023
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LIBRIS-ID:oai:gup.ub.gu.se/332941
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https://gup.ub.gu.se/publication/332941URI
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https://doi.org/10.1016/j.urolonc.2023.09.016DOI
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Objectives: Many patients experience pain, anxiety, and discomfort with prostate biopsy, which may discourage enrollment in active surveillance programs or follow-up biopsy. Guided meditation can significantly reduce pain and anxiety during percutaneous biopsy. We sought to evaluate the effectiveness of a brief mind-body intervention on patient-reported outcomes after prostate biopsy. Methods and materials: We performed a clinically-integrated randomized controlled trial of a brief mind-body intervention during biopsy compared to usual care at a single tertiary care center from 2018 to 2022. All patients offered transrectal ultrasound-guided prostate biopsy in the clinic with local anesthesia were eligible for enrollment. This clinically integrated trial was conducted simultaneously with a randomized controlled trial of 1-stage and 2-stage consent. The primary outcome was patient-reported pain, anxiety, discomfort, and tolerability on a visual-analog scale (0–10). A 15% improvement was prespecified as clinically relevant. We compared the proportion of men in each arm reporting a severe score (7–10) on any of the 4 scales using Fisher's exact test and then compared means for each scale separately using ANCOVA with randomization stratum (first vs. prior biopsy) as a covariate. Results: Of 263 eligible patients, 238 enrolled (119 per arm). One hundred seventy-two (72%) enrolled with 2-stage consent. A total of 37/94 (39%) and 38/102 (37%) patients randomized to usual care and intervention, respectively, reported severe scores in any of the 4 domains, a difference of 2.1% (95% confidence interval [CI] -13, 17%, P = 0.8). There was no evidence of a difference in mean postbiopsy anxiety (P = 0.3), discomfort (P = 0.09), pain (P = 0.4) or tolerability scores (P = 0.2). Conclusions: A clinically meaningful benefit for this brief mind-body intervention during prostate biopsy is unlikely. Robust patient enrollment is feasible using 2-stage consent.
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Biuppslag (personer, institutioner, konferenser, titlar ...)
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Vertosick, Emily A.
(författare)
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Carlsson, Sigrid VGothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology
(författare)
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Lin, Xin
(författare)
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Wolchasty, Natalie
(författare)
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Hardbattle, Robin
(författare)
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Vickers, Andrew J.
(författare)
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Ehdaie, Behfar
(författare)
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Göteborgs universitetInstitutionen för kliniska vetenskaper, Avdelningen för urologi
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Urologic Oncology: Seminars and Original Investigations41:121078-14391873-2496
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