Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-11-05
2021-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Stress ball
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.
Control group
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Not wanting sedation during upper gastrointestinal endoscopy
* Being between the ages of 18-75
* Being willing to participate in research
Exclusion Criteria
* Using antidepressants, anxiolytic and sedative drugs
* Having communication difficulties and mental disability
18 Years
75 Years
ALL
Yes
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Elif Gezginci
Rn, PhD, Asst Prof.
Principal Investigators
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Elif Gezginci, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
Saglik Bilimleri Universitesi
Locations
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University of Health Sciences Turkey
Istanbul, , Turkey (Türkiye)
Countries
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References
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Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17.
Other Identifiers
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20-85
Identifier Type: -
Identifier Source: org_study_id