The Effect of Stress Ball Used During Endoscopy

NCT04519931 | Completed DMC

• 1 other identifier: 20-85
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety; Satisfaction

Keywords

anxiety; endoscopy; pain; nursing; stress ball

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score change on anxiety level as measured by State-Trait Anxiety Inventory

  just before and after procedure

Other Outcomes (1)

• Change on satisfaction level as measured by Visual Analog Scale

  just after procedure

Study Arms (2)

Stress ball

EXPERIMENTAL

Other: Stress ball

Control group

NO INTERVENTION

Interventions

Stress ball OTHER

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.

Stress ball

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Using analgesic or anesthetic drugs before or during the procedure
• Using antidepressants, anxiolytic and sedative drugs
• Having communication difficulties and mental disability

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Turkey

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37199436 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Elif Gezginci, RN, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rn, PhD, Asst Prof.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: November 5, 2020
• Primary Completion: March 4, 2021
• Study Completion: September 1, 2021
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)