Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Status: Completed

Conditions: Urinary Tract Stones; Anxiety; Pain

Treatments: Other: Music; Other: Stress ball

Study type: Interventional

Funder types: Other

Identifiers

NCT02725281

50687469-1491-85-14/1648.4-464

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Control group

No Intervention group

Description:

The patients in "Group 1" didn't receive any intervention during ESWL.

Stress ball

Active Comparator group

Description:

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.

Treatment:

Other: Stress ball

Music

Active Comparator group

Description:

The patients in "Group 3" were listened to the music chosen by them with a headset as a nonpharmacological method during lithotripsy.

Treatment:

Other: Music