Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

March 27, 2016 updated by: Elif Gezginci, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Comparison of Two Different Distraction Methods Affecting the Level of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The patients in "Group-I" were not interfered by researchers before and during lithotripsy.
Active Comparator: Stress ball
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
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.
Active Comparator: Music
The patients in "Group-III" 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 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.

What is the study measuring?

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
Time Frame: 5 min before and 5 min after the ESWL process
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
Time Frame: 5 min before and 5 min after the ESWL process
Anxiety
5 min before and 5 min after the ESWL process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

  • Principal Investigator: Elif Gezginci, RN,PhDs, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
  • Study Director: Emine Iyigun, RN,AssocProf, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
  • Principal Investigator: Serdar Yalcin, MD, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
  • Study Director: Selahattin Bedir, MD,Prof, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
  • Study Director: Yasar I. Ozgok, MD,Prof, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 27, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 27, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50687469-1491-85-14/1648.4-464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Stress ball

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe