Clinical trial NCT02725281: Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
Official title: Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Stones
Pain
Anxiety
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* To refuse to participate in this study,
* Not to meet the inclusion criteria.

Primary outcomes:
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
timeFrame: 5 min before and 5 min after the ESWL process
Secondary outcomes:
measure: A change on anxiety level in STAI-SA (State-Trait Anxiety Inventory-State Anxiety) at the end of procedure compared with the baseline
timeFrame: 5 min before and 5 min after the ESWL process
Other outcomes:
Locations:
Study officials:
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: Elif Gezginci, RN,PhDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: Emine Iyigun, RN,AssocProf
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: Serdar Yalcin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: Selahattin Bedir, MD,Prof
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: Yasar I. Ozgok, MD,Prof
role: STUDY_DIRECTOR
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