Effectiveness of the Music With Structured Verbal Training During Prostate Biopsy

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT04466202
Collaborator
(none)
100
1
2
11.3
8.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Music with Structured Verbal Training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Effect of Music With Structured Verbal Training on Pain, Anxiety and Satisfaction During Prostate Biopsy
Actual Study Start Date :
Jan 22, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music Group with Structured Verbal Training

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

Other: 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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. change on pain intensity as measured by Visual Analog Scale ["just before procedure", "during procedure" and "5 minutes after procedure"]

    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

  1. score change on anxiety level as measured by State-Trait Anxiety Inventory ["just before procedure" and "5 minutes after procedure"]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 86 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saglik Bilimleri Universitesi Istanbul Turkey

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Elif Gezginci, PhD, Saglik Bilimleri Universitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elif Gezginci, RN, PhD, Asst Prof, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT04466202
Other Study ID Numbers:
  • 2020.02.13-07
First Posted:
Jul 10, 2020
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif Gezginci, RN, PhD, Asst Prof, Saglik Bilimleri Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2021