An interventional study of Stress ball and Music in Urinary Tract Stones, Pain and Anxiety, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Not applicable, Interventional, and Other
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.
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).
159 studies on the registry are indexed under Urinary Calculi; 29 are open to participants now.
This study's enrollment of 120 is close to the median of 112 across 108 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 65 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients in "Group 1" didn't receive any intervention during ESWL.
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.
Other: Stress ball
The patients in "Group 3" were listened to the music chosen by them with a headset as a nonpharmacological method during lithotripsy.
Other: Music
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.
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.
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
Time frame: 5 min before and 5 min after the ESWL process
A change on anxiety level in STAI-SA (State-Trait Anxiety Inventory-State Anxiety) at the end of procedure compared with the baseline
Anxiety
Time frame: 5 min before and 5 min after the ESWL process
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi