Condition category
Urological and Genital Diseases
Date applied
14/07/2018
Date assigned
29/07/2018
Last edited
30/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kidney stones are solid crystals of waste products from the blood that can build up in the kidneys. A treatment for kidney stones is extracorporeal shock wave lithotripsy (SWL), which is where shock waves from outside the body are used to break apart the kidney stones so that eventually, they are small enough to pass through the urine. SWL can cause pain and anxiety for patients. The aim of this study was to investigate the effects of listening to different music types during SWL on the patient's pain control, anxiety level, and satisfaction.

Who can participate?
Adults who have a radiopaque kidney stone 10-20 mm in diameter localized in the renal pelvis or ureteropelvic junction

What does the study involve?
All patients will receive SWL, but will be randomised into five different groups:
1. Group 1 wears no headphones and listens to no music during SWL
2. Group 2 wears headphones but listens to no music during SWL
3. Group 3 listens to Turkish art music with headphones during SWL
4. Group 4 listens to Western classical music with headphones during SWL
5. Group 5 listens to music of their choice during SWL
Patients will then be asked to provide pain and anxiety scores after treatment.

What are the possible benefits and risks of participating?
The possible benefit of participating is reduced levels of pain and anxiety associated with SWL treatment. There only risks to participants are the standard risks associated with SWL treatment.

Where is the study run from?
Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey.

When is the study starting and how long is it expected to run for?
May 2015 to January 2018

Who is funding the study?
The study is self-funded:
1. Dr Ali Çift (Turkey)
2. Dr Alper Gök (Turkey)

Who is the main contact?
1. Dr. Ali Çift, alicift@mynet.com
2. Dr. Alper Gök, alper_gok@hotmail.com


Trial website

Contact information

Type

Scientific

Primary contact

Dr ALPER GÖK

ORCID ID

http://orcid.org/0000-0001-6874-4151

Contact details

ayvalı mahallesi mecit caddesi mutlu sitesi 1a/5
Mutlu sitesi
Ankara
06000
Turkey
+905326031181
alper_gok@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Effect of different musical types on patient’s relaxation, anxiety and pain perception during Shock Wave Lithotripsy

Acronym

Study hypothesis

Is there effect of listening different music types during extracorporeal shock wave lithotripsy on the patient's pain control, anxiety level, and satisfaction?

Ethics approval

University of Adıyaman ethics board, 22/06/2016, 2016/5-5

Study design

Observational prospective randomised cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the following contact details to request a participant information sheet: alicift@mynet.com

Condition

Kidney stones

Intervention

Shock Wave Lithotripsy. Participants were randomly divided into the study groups.
Brief summary of methodology: The patients were divided into five groups by randomizing prospectively. A total of 150 patients (30 participants in each group) who underwent first-session SWL were included in the study. Demographic data related to patients and procedure, State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure (0: never 4: happily), and patient satisfaction rates (0: poor 4: excellent) were recorded immediately after the procedure.

Participants were randomly divided into five study groups:
1. Group 1 wore no headphones and no music was played during extracorporeal shock wave lithotripsy (ESWL)
2. Group 2 wore headphones but no music was played during ESWL
3. Group 3 listened to Turkish art music with headphones during ESWL
4. Group 4 listened to Western classical music with headphones during ESWL
5. Group 5 listened to music of the participant's choice with headphones during ESWL

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

The following were assessed immediately after the extracorporeal shock wave lithotripsy procedure:
1. Anxiety, assessed using the State-Trait Anxiety Inventory-State Anxiety form (STAI-SA)
2. Pain, assessed using the Visual Analog Scale (VAS)

Secondary outcome measures

The following were assessed immediately after the extracorporeal shock wave lithotripsy procedure:
1. Willingness to repeat procedure, assessed on a scale of 0-4 where 0 indicates "never", 1 indicates "very little", 2 indicates "little", 3 indicates "much" and 4 indicates "happily"
2. Patient satisfaction, assessed on a scale of 0-4 where 0 indicates "poor", 1 indicates "very little", 2 indicates "little", 3 indicates "much" and 4 indicates "excellent"

Overall trial start date

01/05/2015

Overall trial end date

30/01/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Radiopaque stone 10-20 mm in diameter, localised in the renal pelvis or ureteropelvic (UP) junction
2. Aged 18 years of old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Previous treatment with shock wave lithotropsy
2. Ureteral stents
3. Renal colic

Recruitment start date

01/07/2016

Recruitment end date

30/11/2017

Locations

Countries of recruitment

Turkey

Trial participating centre

Department of Urology, Faculty of Medicine, Adıyaman University, Adress: Yunus Emre Mahallesi, 1164. Sk. No:13, 02000 Merkez/Adıyaman, Turkey.
Adress: Yunus Emre Mahallesi, 1164. Sk. No:13, 02000 Merkez/Adıyaman Merkez/Adıyaman
Adıyaman
02000
Turkey

Sponsor information

Organisation

University of Adıyaman, Adıyaman, Turkey

Sponsor details

Yunus Emre Mahallesi
1164. Sk. No:13
02000 Merkez/Adıyaman Merkez/Adıyaman
Adıyaman
02000
Turkey
+904162161015
alper_gok@hotmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

None

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish in BMC Urology.

IPD sharing statement:
The datasets generated and analysed during the current study are available upon request from Dr. Ali Çift by e-mail (alicift@mynet.com). All the data is available in Excel format for all researchers whenever wanted. Written informed consents were obtained from all patients for participating to this study. There are no ethical or legal restrictions.

Intention to publish date

01/08/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes