Effect of different musical types on shock wave lithotripsy for kidney stone treatment
| ISRCTN | ISRCTN85279715 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85279715 |
| Secondary identifying numbers | 1 |
- Submission date
- 14/07/2018
- Registration date
- 29/07/2018
- Last edited
- 30/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
ayvalı mahallesi mecit caddesi mutlu sitesi 1a/5
Mutlu sitesi
Ankara
06000
Türkiye
 ORCID ID |
0000-0001-6874-4151 |
|---|---|
| Phone | +905326031181 |
| alper_gok@hotmail.com |
Study information
| Study design | Observational prospective randomised cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the following contact details to request a participant information sheet: alicift@mynet.com |
| Scientific title | Effect of different musical types on patient’s relaxation, anxiety and pain perception during Shock Wave Lithotripsy |
| Study objectives | 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(s) | University of Adıyaman ethics board, 22/06/2016, 2016/5-5 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2015 |
| Completion date | 30/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key exclusion criteria | 1. Previous treatment with shock wave lithotropsy 2. Ureteral stents 3. Renal colic |
| Date of first enrolment | 01/07/2016 |
| Date of final enrolment | 30/11/2017 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Adıyaman
02000
Türkiye
Sponsor information
Hospital/treatment centre
Yunus Emre Mahallesi, 1164. Sk. No:13, 02000 Merkez/Adıyaman Merkez/Adıyaman
Adıyaman
02000
Türkiye
| Phone | +904162161015 |
|---|---|
| alper_gok@hotmail.com | |
"ROR" |
https://ror.org/02s4gkg68 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish in BMC Urology. |
| IPD sharing plan | 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. |
