The Effects Of Music In Retrograde Intrarenal Surgery
The Effects Of Music Listening In Patients Undergoing Retrograde Intrarenal Surgery On Basic Life Findings, Anxiety, Pain, And The Amount Of Analgesic Used.
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aimed to investigate the effect of music listening during the preoperative and postoperative stages in patients undergoing retrograde intrarenal surgery(RIRS) on basic life findings, anxiety, pain, and the amount of analgesic used. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=30) and control group (n=30). The control group received standard care. In contrast, the intervention group, in addition to standard care, was listened to the music by the researchers for 15 minutes one hour before their surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Submitted
Initial submission to the registry
August 2, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedAugust 5, 2020
August 1, 2020
8 months
August 2, 2020
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale for Anxiety (VAS-A)
VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety" .
2 days
Secondary Outcomes (1)
Visual Analog Scale for Pain (VAS)
1 day
Study Arms (2)
Music Intervention Group
EXPERIMENTALThe music intervention group listened to the music by the researchers for the duration of 15 minutes one hour before the surgery as well as the standard care.
No Intervention Group
NO INTERVENTIONThe control group patients received standard care only.
Interventions
The music type was chosen by the patients and researchers did not have any influence on their choices.
Eligibility Criteria
You may qualify if:
- years of age or above,
- had elective RIRS,
- without hearing/speech impairment,
- without mental problems,
- without a diagnosis of psychiatric disorders,
- without a diagnosis of depression,
- had the surgery under general anesthesia,
- and volunteered to participate.
You may not qualify if:
- Patients under 18 years of age,
- with hearing/speech impairment,
- with mental problems,
- with a diagnosis of psychiatric disorders,
- with a diagnosis of depression,
- undergoing the surgery through spinal anesthesia,
- not willing to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Afyonkarahisar Health Science University
Afyonkarahisar, Centre, 03200, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Proffesor PhD
Study Record Dates
First Submitted
August 2, 2020
First Posted
August 5, 2020
Study Start
May 14, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
August 5, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share