Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

NCT ID: NCT04466202

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2020-12-31

Brief Summary

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Transrectal ultrasound (TRUS) guided prostate biopsy is a gold standard method widely used in the diagnosis of prostate cancer. This procedure can be very painful and anxious for men. Various pharmacological methods can be used to relieve patients' pain and discomfort during TRUS-guided prostate biopsy. Although there is still no consensus on the solution suggestions for pain and anxiety due to biopsy, it is known that music, which is a non-pharmacological method, is effective in this regard. The aim of this study is to evaluate the effect of music with structured verbal training on patients' pain, anxiety and satisfaction levels during transrectal ultrasound-guided prostate biopsy.

Detailed Description

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Although there have been several studies examining the effect of music on pain and / or anxiety during TRUS prostate biopsy, only one study has been found examining the effect of stress management (music and one-to-one simulation training) on patients' pain and anxiety levels. In addition, there is only one study on the effectiveness of the training method (written and video-based training) on anxiety levels of patients related to prostate biopsy. For this reason, it is thought that music will be more effective on pain and anxiety levels along with structured verbal training to alleviate the discomfort associated with patients' biopsy procedure.

Conditions

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Pain Anxiety Satisfaction Urological Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Music Group with Structured Verbal Training

Music with structured verbal training was applied during transrectal ultrasound guided prostate biopsy.

Group Type EXPERIMENTAL

Music with Structured Verbal Training

Intervention Type OTHER

Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.

Control Group

The control group did not listen to music during the procedure, and they received routine training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music with Structured Verbal Training

Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being over the age of 40
* male gender
* transrectal ultrasound guided prostate biopsy for the first time
* agreeing to participate in the study

Exclusion Criteria

* presence of any contraindication for prostate biopsy
* any analgesic used 24 hours before prostate biopsy
Minimum Eligible Age

40 Years

Maximum Eligible Age

86 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Elif Gezginci

RN, PhD, Asst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Gezginci, PhD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Saglik Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

Reference Type BACKGROUND
PMID: 11733293 (View on PubMed)

Chang YH, Oh TH, Lee JW, Park SC, Seo IY, Jeong HJ, Kwon WA. Listening to music during transrectal ultrasound-guided prostate biopsy decreases anxiety, pain and dissatisfaction in patients: a pilot randomized controlled trial. Urol Int. 2015;94(3):337-41. doi: 10.1159/000368420. Epub 2014 Dec 18.

Reference Type BACKGROUND
PMID: 25531837 (View on PubMed)

Chiu LP, Tung HH, Lin KC, Lai YW, Chiu YC, Chen SS, Chiu AW. Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Patient Prefer Adherence. 2016 Feb 11;10:147-52. doi: 10.2147/PPA.S96991. eCollection 2016.

Reference Type BACKGROUND
PMID: 26929606 (View on PubMed)

Cho SW, Choi HJ. Effect of Music on Reducing Anxiety for Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies: Randomized Prospective Trial. Urol J. 2016 Apr 16;13(2):2612-4.

Reference Type BACKGROUND
PMID: 27085561 (View on PubMed)

Chopra S, Rowe EW, Laniado M, Patel A. A prospective study analysing the effect of pain on probe insertion, and the biopsy strategy, on the patients' perception of pain during TRUS-guided biopsy of the prostate. N Z Med J. 2008 Dec 12;121(1287):39-43.

Reference Type BACKGROUND
PMID: 19098966 (View on PubMed)

Packiam VT, Nottingham CU, Cohen AJ, Eggener SE, Gerber GS. No Effect of Music on Anxiety and Pain During Transrectal Prostate Biopsies: A Randomized Trial. Urology. 2018 Jul;117:31-35. doi: 10.1016/j.urology.2018.04.014. Epub 2018 Apr 27.

Reference Type BACKGROUND
PMID: 29709434 (View on PubMed)

Tsivian M, Qi P, Kimura M, Chen VH, Chen SH, Gan TJ, Polascik TJ. The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology. 2012 Jan;79(1):32-6. doi: 10.1016/j.urology.2011.09.037.

Reference Type BACKGROUND
PMID: 22202544 (View on PubMed)

Other Identifiers

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2020.02.13-07

Identifier Type: -

Identifier Source: org_study_id

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