Clinical trial NCT04519931: The Effect of Stress Ball Used During Endoscopy
Official title: The Effect of Using a Stress Ball on Pain, Anxiety and Satisfaction During the Endoscopy Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Satisfaction
Keywords: anxiety
endoscopy
pain
nursing
stress ball
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change on pain intensity as measured by Visual Analog Scale
timeFrame: just before procedure, during, and just after procedure
Secondary outcomes:
measure: Score change on anxiety level as measured by State-Trait Anxiety Inventory
timeFrame: just before and after procedure
Other outcomes:
measure: Change on satisfaction level as measured by Visual Analog Scale
timeFrame: just after procedure
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Elif Gezginci, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: