search
Back to results

Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

Primary Purpose

Pain, Anxiety, Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music with Structured Verbal Training
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain focused on measuring Anxiety, Nursing, Pain, Satisfaction, Prostate biopsy

Eligibility Criteria

40 Years - 86 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Saglik Bilimleri Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Group with Structured Verbal Training

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

score change on anxiety level as measured by State-Trait Anxiety Inventory
The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.

Full Information

First Posted
July 6, 2020
Last Updated
February 8, 2021
Sponsor
Saglik Bilimleri Universitesi
search

1. Study Identification

Unique Protocol Identification Number
NCT04466202
Brief Title
Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy
Official Title
The Effect of Music With Structured Verbal Training on Pain, Anxiety and Satisfaction During Prostate Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Satisfaction, Urological Nursing
Keywords
Anxiety, Nursing, Pain, Satisfaction, Prostate biopsy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Group with Structured Verbal Training
Arm Type
Experimental
Arm Description
Music with structured verbal training was applied during transrectal ultrasound guided prostate biopsy.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group did not listen to music during the procedure, and they received routine training.
Intervention Type
Other
Intervention Name(s)
Music with Structured Verbal Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
change on pain intensity as measured by Visual Analog Scale
Description
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.
Time Frame
"just before procedure", "during procedure" and "5 minutes after procedure"
Secondary Outcome Measure Information:
Title
score change on anxiety level as measured by State-Trait Anxiety Inventory
Description
The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale is used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.
Time Frame
"just before procedure" and "5 minutes after procedure"

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Gezginci, PhD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saglik Bilimleri Universitesi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11733293
Citation
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.
Results Reference
background
PubMed Identifier
25531837
Citation
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.
Results Reference
background
PubMed Identifier
26929606
Citation
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.
Results Reference
background
PubMed Identifier
27085561
Citation
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.
Results Reference
background
PubMed Identifier
19098966
Citation
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.
Results Reference
background
PubMed Identifier
29709434
Citation
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.
Results Reference
background
PubMed Identifier
22202544
Citation
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.
Results Reference
background

Learn more about this trial

Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

We'll reach out to this number within 24 hrs