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The Effect of Stress Ball Used During Endoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04519931
Enrollment
60
Registered
2020-08-20
Start date
2020-11-05
Completion date
2021-09-01
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain, Satisfaction

Keywords

anxiety, endoscopy, pain, nursing, stress ball

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.

Interventions

OTHERStress 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.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change on pain intensity as measured by Visual Analog Scalejust before procedure, during, and just after procedureThe 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

MeasureTime frameDescription
Score change on anxiety level as measured by State-Trait Anxiety Inventoryjust before and after procedureThe 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.

Other

MeasureTime frameDescription
Change on satisfaction level as measured by Visual Analog Scalejust after procedureThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026