The Effect of Stress Ball Used During Endoscopy

Not Applicable

Completed

• Conditions: Pain; Anxiety; Satisfaction
• Interventions: Other: Stress ball

• Registration Number: NCT04519931
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

Endoscopy procedure is a frequently used method in the evaluation of the gastrointestinal system. Upper gastrointestinal system endoscopy can be performed with and without sedation. Sedation is the controlled sleep of the patient with certain drugs (pharmacological methods). Non-pharmacological methods help reduce anxiety and pain. In this study, a non-pharmacological stress ball will be used. It is aimed to evaluate the effect of using a stress ball on pain, anxiety and satisfaction during upper gastrointestinal system endoscopy.

Detailed Description

Patients do not want to think that an upper GIS endoscopy without sedation will be difficult. However, some complications can be seen like hypoxemia, allergic reaction, malignant hyperthermia, hypoventilation, respiratory depression, hypotension, bradycardia, apnea, hypoxia, etc. due to sedation applied during endoscopy.

Non-pharmacological methods help reduce anxiety and pain. Although sedative and analgesic medications reduce anxiety and relieve pain, endoscopy is still painful for patients. During the endoscopy process, non-pharmacological methods are used to draw attention to another direction, but it is not encountered that the stress ball is used as one of these methods in the endoscopy procedure.

This study was planned as a single-center prospective randomized controlled study for the treatment of the stress ball method used during the endoscopy procedure, pain in anxiety and satisfaction levels.

The data obtained in the study will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean, standard deviation will be used as descriptive statistical methods in the evaluation of data. In comparing the difference between two independent groups, Student's t test will be used for data conforming to normal distribution, and Mann-Whitney U test will be used for data that do not comply with normal distribution. The difference between two repeated measurements will be analyzed with dependent groups t-test for data conforming to normal distribution, and Wilcoxon test for data that do not conform to normal distribution. The difference between three and more measurements that do not comply with the normal distribution will be compared with the analysis of variance in repeated measures for data that do not fit the normal distribution, and with the Friedman test for data that do not comply with the normal distribution. A value of P \<0.05 will be considered as statistically significant.

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Study Start: 2020-11-05
• Primary Completion: 2021-03-04
• Study Completion: 2021-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• To have an upper gastrointestinal endoscopy for the first time
• Not wanting sedation during upper gastrointestinal endoscopy
• Being between the ages of 18-75
• Being willing to participate in research

Exclusion Criteria

• Using analgesic or anesthetic drugs before or during the procedure
• Using antidepressants, anxiolytic and sedative drugs
• Having communication difficulties and mental disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress ball	Stress ball	-

Primary Outcome Measures

Name	Time	Method
Change on pain intensity as measured by Visual Analog Scale	just before procedure, during, and just after procedure	The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.

Secondary Outcome Measures

Name	Time	Method
Score change on anxiety level as measured by State-Trait Anxiety Inventory	just before and after procedure	The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale in used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.

Trial Locations

Locations (1)

University of Health Sciences Turkey; 🇹🇷 Istanbul, Turkey