Retrograde Intrarenal SurgeryNCT04500054
The Effects Of Music In Retrograde Intrarenal Surgery
A study testing Music Listening in people with Retrograde Intrarenal Surgery, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retrograde Intrarenal Surgery
- What is being tested?
- Music Listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, Centre, 03200
About this study
Official title: The Effects Of Music Listening In Patients Undergoing Retrograde Intrarenal Surgery On Basic Life Findings, Anxiety, Pain, And The Amount Of Analgesic Used.
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.
- Conditions
- Retrograde Intrarenal Surgery
- Being tested
- Music Listening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningOther
The music type was chosen by the patients and researchers did not have any influence on their choices.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention Group | Experimental | The 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. Receives: Other: Music Listening |
| No Intervention Group | No intervention | The control group patients received standard care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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" .
Measured: 2 days
Secondary outcomes (1)
Visual Analog Scale for Pain (VAS)
VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start14 May 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrograde Intrarenal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Ciğerci, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500054
- Sponsor's protocol ID
- (2019/165
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Music Listening In Patients Undergoing Retrograde Intrarenal Surgery On Basic Life Findings, Anxiety, Pain, And The Amount Of Analgesic Used.
- ClinicalTrials.gov ID
- NCT04500054
- Acronym / sponsor ID
- (2019/165
- Conditions
- Retrograde Intrarenal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention Group | Experimental | Other: Music ListeningThe 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 intervention | –The control group patients received standard care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or above,
- had elective RIRS,
- without hearing/speech impairment,
- without mental problems,
- without a diagnosis of psychiatric disorders,
Key exclusion criteria (7 listed)
- Patients under 18 years of age,
- with hearing/speech impairment,
- with mental problems,
- with a diagnosis of psychiatric disorders,
- with a diagnosis of depression,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ListeningThe music type was chosen by the patients and researchers did not have any influence on their choices. | Other | Music Intervention Group |
Primary outcome
Visual Analog Scale for Anxiety (VAS-A)
Time frame: 2 days
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" .
1 secondary outcome
Visual Analog Scale for Pain (VAS)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening in people with Retrograde Intrarenal Surgery, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Anxiety (VAS-A) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.