Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

NCT04466202 | Completed DMC

• 1 other identifier: 2020.02.13-07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Anxiety; Satisfaction; Urological Nursing

Keywords

Anxiety; Nursing; Pain; Satisfaction; Prostate biopsy

Outcome Measures

Primary Outcomes (1)

• change on pain intensity as measured by Visual Analog Scale

  The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm (0-100 mm). High scores on the scale indicate that pain intensity is high.

  "just before procedure", "during procedure" and "5 minutes after procedure"

Secondary Outcomes (1)

• score change on anxiety level as measured by State-Trait Anxiety Inventory

  "just before procedure" and "5 minutes after procedure"

Study Arms (2)

Music Group with Structured Verbal Training

EXPERIMENTAL

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

Other: Music with Structured Verbal Training

Control Group

NO INTERVENTION

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

Interventions

Music with Structured Verbal Training 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.

Music Group with Structured Verbal Training

Eligibility Criteria

• Age: 40 Years - 86 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• presence of any contraindication for prostate biopsy
• any analgesic used 24 hours before prostate biopsy

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 11733293 BACKGROUND

• 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.

  PMID: 25531837 BACKGROUND

• 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.

  PMID: 26929606 BACKGROUND

• 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.

  PMID: 27085561 BACKGROUND

• 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.

  PMID: 19098966 BACKGROUND

• 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.

  PMID: 29709434 BACKGROUND

• 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.

  PMID: 22202544 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Elif Gezginci, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Asst Prof

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: January 22, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)