The Effect of Stress Ball Used During Endoscopy

Pain Clinical Trial

Official title:

The Effect of Using a Stress Ball on Pain, Anxiety and Satisfaction During the Endoscopy Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04519931
• Other study ID #: 20-85
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2021
• Source: Saglik Bilimleri Universitesi
• Contact: Tugba Caner
• Phone: +905437939102
• Email: cantubik91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 1, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Satisfaction

Intervention

Other:
• Stress ball
The stress ball is a toy, usually no larger than 7 cm. It is used to relieve stress and muscle tension. Stress ball is one of the cognitive and behavioral therapy methods used in pain control. Stress ball is used as a method of diverting attention during painful procedures. It appears to reduce pain and anxiety.

Locations

Country	Name	City	State
Turkey	University of Health Sciences Turkey	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change on satisfaction level as measured by Visual Analog Scale	The average score change on satisfaction level as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure satisfaction level. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that satisfaction level is high.	just after procedure
Primary	Change on pain intensity as measured by Visual Analog Scale	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.	just before procedure, during, and just after procedure
Secondary	Score change on anxiety level as measured by State-Trait Anxiety Inventory	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.	just before and after procedure