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The Effect of Stress Ball Used During Endoscopy

Primary Purpose

Pain, Anxiety, Satisfaction

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stress ball
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring anxiety, endoscopy, pain, nursing, stress ball

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Health Sciences TurkeyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stress ball

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 17, 2020
Last Updated
June 29, 2021
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04519931
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Satisfaction
Keywords
anxiety, endoscopy, pain, nursing, stress ball

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress ball
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Stress ball
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on pain intensity as measured by Visual Analog Scale
Description
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.
Time Frame
just before procedure, during, and just after procedure
Secondary Outcome Measure Information:
Title
Score change on anxiety level as measured by State-Trait Anxiety Inventory
Description
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.
Time Frame
just before and after procedure
Other Pre-specified Outcome Measures:
Title
Change on satisfaction level as measured by Visual Analog Scale
Description
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.
Time Frame
just after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuğba Caner
Phone
+905437939102
Email
cantubik91@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Gezginci, RN, PhD
Phone
05320656343
Email
elif.gezginci@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Gezginci, RN, PhD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Turkey
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuğba Caner
Phone
+905437939102
Email
cantubik91@gmail.com
First Name & Middle Initial & Last Name & Degree
Elif Gezginci, Rn, PhD
Phone
05320656343
Email
elif.gezginci@sbu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Stress Ball Used During Endoscopy

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