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Completed

NCT Number: NCT02725281

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.

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Key information

Conditions

Urinary Tract Stones Anxiety Anxiety Disorders Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress ball

Other

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.

Music

Other

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.

Primary outcomes

  1. 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

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

    Time frame: 5 min before and 5 min after the ESWL process

    Anxiety

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 31, 2016
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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