Urinary Tract StonesNCT02725281
Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
A study testing Stress ball and Music in people with Urinary Tract Stones and Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
Investigators observed that during the Extracorporeal Shock Wave Lithotripsy (ESWL) non-pharmacological methods used for reducing the level of the pain and anxiety among the patients with the urinary stones are not sufficient and the effectiveness of these methods is controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Stones, Pain, Anxiety
- What is being tested?
- Stress ball and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Sep 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria of this study were to have kidney or ureter stones eligible for the ESWL procedure based on the European Association of Urology Guideline,
- To be the first lithotripsy treatment,
- To be older than 18 years old,
- To have the body mass index of 30kg/m2 or less,
- Not to be given analgesic before the procedure,
- Not to have renal colic just before ESWL,
- Not to have any contraindication in terms of lithotripsy,
- Not to have ureteral stent.
Who cannot join
- To refuse to participate in this study,
- Not to meet the inclusion criteria.
About this study
Official title: Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
Investigators observed that during the Extracorporeal Shock Wave Lithotripsy (ESWL) non-pharmacological methods used for reducing the level of the pain and anxiety among the patients with the urinary stones are not sufficient and the effectiveness of these methods is controversial. There are very few studies, which investigated the effects of music on the pain and anxiety during ESWL. In addition, any randomized clinical trial related to the use of stress ball for relaxation and distraction on the reduction of pain and anxiety during lithotripsy has not been found in the relevant literature. Investigators also evaluated that further evidence-based studies are necessary. Thus, investigators aimed to investigate the effectiveness of stress ball and music for reducing the pain and anxiety of the patients during ESWL in this study.
Read the detailed description
Extracorporeal Shock Wave Lithotripsy (ESWL), used commonly in urinary stone treatment, can cause pain and anxiety for patients. The aim of this study was to investigate the efficacy of use of music and stress ball to reduce pain and anxiety during lithotripsy. This was a single center parallel-randomized controlled trial. The study sample consisted of a total of 120 patients who applied to lithotripsy unit of urology clinic in a training and research hospital in Turkey between April and September 2014. The patients were randomly divided into three groups. The patients in group-I (control group) were not interfered, while group-II was given stress ball into their palms in order to squeeze and group-III was listened to the music chosen by themselves with a headset during the lithotripsy procedure. Data were collected using the Patient Information Form, Visual Analogue Scale (VAS), and State Trait Anxiety Inventory (STAI-SA).
- Conditions
- Urinary Tract Stones, Pain, Anxiety
- Being tested
- Stress ball, Music
- Medical subject headings
- Urinary Calculi, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballOther
The patients in this group were given stress ball into both their palms 5 minutes before ESWL. Participants were instructed to "squeeze the balls twice after counting up to ten" and "repeat it until the end of the procedure". This ball was medium hard and has been made of high quality silicon.
MusicOther
The patients in this group were also listened to the music chosen by them with a headset from 5 min before until the end of lithotripsy. Types of music played for the patients were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The patients in "Group 1" didn't receive any intervention during ESWL. |
| Stress ball | Active comparator | The patients in "Group 2" were given stress ball into both their palms 5 minutes before ESWL. Participants were instructed to "squeeze the balls twice after counting up to ten" and "repeat it until the end of the procedure". This ball was medium hard and it was made of high quality silicon. Receives: Other: Stress ball |
| Music | Active comparator | The patients in "Group 3" were listened to the music chosen by them with a headset as a nonpharmacological method during lithotripsy. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change on pain severity in VAS (Visual Analogue Scale) pain scale reported by the patients at the end of lithotripsy procedure compared with the baseline
Pain
Measured: 5 min before and 5 min after the ESWL process
Secondary outcomes (1)
A change on anxiety level in STAI-SA (State-Trait Anxiety Inventory-State Anxiety) at the end of procedure compared with the baseline
Anxiety
Measured: 5 min before and 5 min after the ESWL process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract StonesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Elif Gezginci, RN,PhDs, Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip FakultesiEmine Iyigun, RN,AssocProf, Study director, Saglik Bilimleri Universitesi Gulhane Tip FakultesiSerdar Yalcin, MD, Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip FakultesiSelahattin Bedir, MD,Prof, Study director, Saglik Bilimleri Universitesi Gulhane Tip FakultesiYasar I. Ozgok, MD,Prof, Study director, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725281
- Sponsor's protocol ID
- 50687469-1491-85-14/1648.4-464
- Status last verified
- Dec 2024
- First submitted
- 14 Mar 2016
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aboumarzouk OM, Kata SG, Keeley FX, McClinton S, Nabi G. Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD006029. doi: 10.1002/14651858.CD006029.pub4.
PubMed 22592707Akin Y, Yucel S. Long-term effects of pediatric extracorporeal shockwave lithotripsy on renal function. Res Rep Urol. 2014 Apr 28;6:21-5. doi: 10.2147/RRU.S40965. eCollection 2014.
PubMed 24892029Bosio, A., Destefanis, P., Buffardi, A., Alessandria, E., Dalmasso, E., Lucci Chiarissi, M., Berta, G., Bisconti, A., Fontana, D., & Frea, B. E68 Does music reduce discomfort during ESWL? A prospective randomized trial. European Urology Supplements, 2013 3;12:53.
Cepeda MS, Diaz JE, Hernandez V, Daza E, Carr DB. Music does not reduce alfentanil requirement during patient-controlled analgesia (PCA) use in extracorporeal shock wave lithotripsy for renal stones. J Pain Symptom Manage. 1998 Dec;16(6):382-7. doi: 10.1016/s0885-3924(98)00099-2.
PubMed 9879163Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.
PubMed 15056325Demir, Y. (2012). Non-pharmacological therapies in pain management. INTECH Open Access Publisher.
Diana, K.J., & George, K.V. (2013). Urinary stone formation: Efficacy of seed extract of Ensete superbum (Roxb.) Cheesman on growth inhibition of calcium hydrogen phosphate dihydrate crystals. Journal of Crystal Growth, 363, 164-170.
Joshi HN, Karmacharya RM, Shrestha R, Shrestha B, de Jong IJ, Shrestha RK. Outcomes of extra corporeal shock wave lithotripsy in renal and ureteral calculi. Kathmandu Univ Med J (KUMJ). 2014 Jan-Mar;12(45):51-4. doi: 10.3126/kumj.v12i1.13639.
PubMed 25219995Karabulut, N., Gürçayır, D., & Aktaş, Y.Y. (2015). Non-pharmacological interventions for pain management used by nursing students in Turkey. Kontakt.
Lee DW, Chan KW, Poon CM, Ko CW, Chan KH, Sin KS, Sze TS, Chan AC. Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Jan;55(1):33-6. doi: 10.1067/mge.2002.120387.
PubMed 11756911Ngee-Ming G, Tamsin D, Rai BP, Somani BK. Complementary approaches to decreasing discomfort during shockwave lithotripsy (SWL). Urolithiasis. 2014 Jun;42(3):189-93. doi: 10.1007/s00240-014-0655-2. Epub 2014 Mar 20.
PubMed 24648110Öner, N., & Le Compte, A. (1985). Durumluk/Sürekli Kaygi Envanteri El Kitabı. (State-Trait Anxiety Inventory Handbook) 2. Baskı, Boğaziçi Üniversitesi Yayınları, Istanbul No:333, 52-56.
Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18.
PubMed 24602425Pearle, M.S., & Lotan, Y. (2012). Urinary lithiasis: etiology, epidemiology, and pathogenesis. Camphel-walsh Urology, 10, 1257-1286.
Perera, N.D., & Perera S.J. (2013). The role of extracorporeal shock wave lithotripsy in renal calculi. Sri Lanka Journal of Surgery, 31(3), 33-40.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
- ClinicalTrials.gov ID
- NCT02725281
- Acronym / sponsor ID
- 50687469-1491-85-14/1648.4-464
- Conditions
- Urinary Tract Stones, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
Investigators observed that during the Extracorporeal Shock Wave Lithotripsy (ESWL) non-pharmacological methods used for reducing the level of the pain and anxiety among the patients with the urinary stones are not sufficient and the effectiveness of these methods is controversial. There are very few studies, which investigated the effects of music on the pain and anxiety during ESWL. In addition, any randomized clinical trial related to the use of stress ball for relaxation and distraction on the reduction of pain and anxiety during lithotripsy has not been found in the relevant literature. Investigators also evaluated that further evidence-based studies are necessary. Thus, investigators aimed to investigate the effectiveness of stress ball and music for reducing the pain and anxiety of the patients during ESWL in this study.
Detailed description
Extracorporeal Shock Wave Lithotripsy (ESWL), used commonly in urinary stone treatment, can cause pain and anxiety for patients. The aim of this study was to investigate the efficacy of use of music and stress ball to reduce pain and anxiety during lithotripsy. This was a single center parallel-randomized controlled trial. The study sample consisted of a total of 120 patients who applied to lithotripsy unit of urology clinic in a training and research hospital in Turkey between April and September 2014. The patients were randomly divided into three groups. The patients in group-I (control group) were not interfered, while group-II was given stress ball into their palms in order to squeeze and group-III was listened to the music chosen by themselves with a headset during the lithotripsy procedure. Data were collected using the Patient Information Form, Visual Analogue Scale (VAS), and State Trait Anxiety Inventory (STAI-SA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The patients in "Group 1" didn't receive any intervention during ESWL. |
| Stress ball | Active comparator | Other: Stress ballThe patients in "Group 2" were given stress ball into both their palms 5 minutes before ESWL. Participants were instructed to "squeeze the balls twice after counting up to ten" and "repeat it until the end of the procedure". This ball was medium hard and it was made of high quality silicon. |
| Music | Active comparator | Other: MusicThe patients in "Group 3" were listened to the music chosen by them with a headset as a nonpharmacological method during lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The inclusion criteria of this study were to have kidney or ureter stones eligible for the ESWL procedure based on the European Association of Urology Guideline,
- To be the first lithotripsy treatment,
- To be older than 18 years old,
- To have the body mass index of 30kg/m2 or less,
- Not to be given analgesic before the procedure,
Key exclusion criteria (2 listed)
- To refuse to participate in this study,
- Not to meet the inclusion criteria.
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 |
|---|---|---|
| Stress ballThe patients in this group were given stress ball into both their palms 5 minutes before ESWL. Participants were instructed to "squeeze the balls twice after counting up to ten" and "repeat it until the end of the procedure". This ball was medium hard and has been made of high quality silicon. | Other | Stress ball |
| MusicThe patients in this group were also listened to the music chosen by them with a headset from 5 min before until the end of lithotripsy. Types of music played for the patients were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music. | Other | Music |
Primary outcome
A change on pain severity in VAS (Visual Analogue Scale) pain scale reported by the patients at the end of lithotripsy procedure compared with the baseline
Time frame: 5 min before and 5 min after the ESWL process
Pain
1 secondary outcome
A change on anxiety level in STAI-SA (State-Trait Anxiety Inventory-State Anxiety) at the end of procedure compared with the baseline
Time frame: 5 min before and 5 min after the ESWL process
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 3 Dec 2024.
- Background: PubMed 22592707Aboumarzouk OM, Kata SG, Keeley FX, McClinton S, Nabi G. Extracorporeal shock wave lithotripsy (ESWL) versus ureteroscopic management for ureteric calculi. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD006029. doi: 10.1002/14651858.CD006029.pub4.
- Background: PubMed 24892029Akin Y, Yucel S. Long-term effects of pediatric extracorporeal shockwave lithotripsy on renal function. Res Rep Urol. 2014 Apr 28;6:21-5. doi: 10.2147/RRU.S40965. eCollection 2014.
- BackgroundBosio, A., Destefanis, P., Buffardi, A., Alessandria, E., Dalmasso, E., Lucci Chiarissi, M., Berta, G., Bisconti, A., Fontana, D., & Frea, B. E68 Does music reduce discomfort during ESWL? A prospective randomized trial. European Urology Supplements, 2013 3;12:53.
- Background: PubMed 9879163Cepeda MS, Diaz JE, Hernandez V, Daza E, Carr DB. Music does not reduce alfentanil requirement during patient-controlled analgesia (PCA) use in extracorporeal shock wave lithotripsy for renal stones. J Pain Symptom Manage. 1998 Dec;16(6):382-7. doi: 10.1016/s0885-3924(98)00099-2.
- Background: PubMed 15056325Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.
- BackgroundDemir, Y. (2012). Non-pharmacological therapies in pain management. INTECH Open Access Publisher.
- BackgroundDiana, K.J., & George, K.V. (2013). Urinary stone formation: Efficacy of seed extract of Ensete superbum (Roxb.) Cheesman on growth inhibition of calcium hydrogen phosphate dihydrate crystals. Journal of Crystal Growth, 363, 164-170.
- Background: PubMed 25219995Joshi HN, Karmacharya RM, Shrestha R, Shrestha B, de Jong IJ, Shrestha RK. Outcomes of extra corporeal shock wave lithotripsy in renal and ureteral calculi. Kathmandu Univ Med J (KUMJ). 2014 Jan-Mar;12(45):51-4. doi: 10.3126/kumj.v12i1.13639.
- BackgroundKarabulut, N., Gürçayır, D., & Aktaş, Y.Y. (2015). Non-pharmacological interventions for pain management used by nursing students in Turkey. Kontakt.
- Background: PubMed 11756911Lee DW, Chan KW, Poon CM, Ko CW, Chan KH, Sin KS, Sze TS, Chan AC. Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Jan;55(1):33-6. doi: 10.1067/mge.2002.120387.
- Background: PubMed 24648110Ngee-Ming G, Tamsin D, Rai BP, Somani BK. Complementary approaches to decreasing discomfort during shockwave lithotripsy (SWL). Urolithiasis. 2014 Jun;42(3):189-93. doi: 10.1007/s00240-014-0655-2. Epub 2014 Mar 20.
- BackgroundÖner, N., & Le Compte, A. (1985). Durumluk/Sürekli Kaygi Envanteri El Kitabı. (State-Trait Anxiety Inventory Handbook) 2. Baskı, Boğaziçi Üniversitesi Yayınları, Istanbul No:333, 52-56.
- 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.
Elif Gezginci, RN,PhDs principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Emine Iyigun, RN,AssocProf study director
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Serdar Yalcin, MD principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball and Music in people with Urinary Tract Stones and Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 2 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 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
A change on pain severity in VAS (Visual Analogue Scale) pain scale reported by the patients at the end of lithotripsy procedure compared with the baseline (time frame: 5 min before and 5 min after the ESWL process). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725281, which also lists 23 linked publications.
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 3 Dec 2024.