Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

Conditions
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Urinary Tract Stones, Pain, Anxiety

Intervention / Treatment
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* Other: Stress ball
* Other: Music


Participation Criteria
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Eligibility Criteria
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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 pain at the time of ESWL, Not to have any contraindication in terms of lithotripsy, Not to have double J ureteral catheter. Exclusion Criteria: To refuse to participate in this study, Not to meet the inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The patients in Group-I were not interfered by researchers before and during lithotripsy. | |
| Active Comparator: Stress ball<br>The patients in Group II were given stress ball into their both palms as a before the lithotripsy and told to squeeze the ball whenever they would like. | Other: Stress ball<br>* The patients in this group were given stress ball into their both palms 5 min before the lithotripsy and told to squeeze the ball whenever they would like until end of the process. This ball was medium hard and has been made of high quality silicon.<br>|
| Active Comparator: Music<br>The patients in Group-III were listened to the music chosen by them with a headset as a nonpharmacological method during lithotripsy. | Other: Music<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 min before and 5 min after the ESWL process | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change on anxiety level in STAI-SA (State-Trait Anxiety Inventory-State Anxiety) at the end of procedure compared with the baseline | Anxiety | 5 min before and 5 min after the ESWL process |