The Effect of Stress Ball and 4-7-8 Breathing Technique on Fear, Anxiety and Physiological Parameters

The Effect of Stress Ball and 4-7-8 Breathing Technique on Pre-Procedure Fear, Anxiety and Physiological Parameters in Elderly Patients Undergoing Endoscopy: Randomized Controlled Study

The study aimed to examine the effects of two different applications (stress ball and 4-7-8 breathing technique) before Upper GI Endoscopy on patients' fear, anxiety and physiological parameters before the procedure.

The study as a single-blind, pre-test and post-test experimental study.

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety; Endoscopy; Cognitive Therapy; Breathing Exercises; Physiological Parameters
• Intervention / Treatment: Other: stress ball; Other: 4-7-8 breathing technique

Detailed Description

Due to the procedures involved, endoscopy patients experience high levels of fear and anxiety. Fear and anxiety may activate the patient's autonomic nervous system, causing increased sweating, heart rate, blood pressure and respiratory rate, and complications related to the procedure. Reducing fear and anxiety and making the patient feel relaxed not only prevents possible harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to examine the effects of stress ball exercise and 4-7-8 breathing technique on the fear, anxiety and vital signs of patients who will undergo Upper Gastrointestinal (GI) endoscopy.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Muğla, Turkey (Türkiye), 48000
    • Mehtap ÇULLU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Upper GI Endoscopy will be performed for the first time,
2. American Society of Anesthesiologists (ASA) Status I-II
3. Those over 18 years of age
4. Participates in the research voluntarily and is willing to cooperate.
5. No visual impairment, hearing impairment or communication problem,
6. Not having a psychiatric diagnosis and not using anxiolytic, hypnotic or sedative drugs

Exclusion Criteria:

1. Those diagnosed with severe respiratory failure
2. Those who have health problems in the hand, wrist or arm area that prevent squeezing the stress ball.
3. Using psychiatric medication (antipsychotic, antidepressant, anxiolytic, sedative, etc.
4. Anyone who wishes to leave the research at any stage of the research, with his or her own initiative.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stress ball; group applying the stress ball for 20 minute before endoscopy	Other: stress ball; Patients squeeze the stress ball
Experimental: 4-7-8 breathing technique; group applying the 4-7-8 breathing technique for 6 sets before endoscopy	Other: 4-7-8 breathing technique; breathing in quietly through the nose for 4 seconds. holding the breath for a count of 7 seconds. exhaling forcefully through the mouth for 8 seconds.
No Intervention: Control group; The group in which no intervention was performed before endoscopy and routine care was given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Developed by Price et al. (1983), VAS is a reliable, valid and practical measurement tool for repeated measurements. The scale, which is generally used to score pain, will be used in this study to score patients' fear between 1-10 points. The scale is represented by a 10 cm line representing the lowest and highest scores for fear (0 = no fear, 10 = most intense fear).	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
State-Trait Anxiety İnventory	It was developed by Spielberger and his colleagues in 1970. It has two parts: State and Trait Anxiety. The State Anxiety Scale section determines how a person feels at a particular moment and under certain conditions. The feelings or behaviors expressed by the person are answered by marking one of the options: (1) not at all, (2) a little, (3) a lot, (4) completely, depending on the degree of severity. Trait Anxiety Scale is related to how the individual feels in general, regardless of the current situation.	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure (mm/Hg)	Measurements are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
diastolic blood pressure (mm/Hg)	Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
SpO2-peripheral oxygen saturation (%)	Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
Respiratory rate (minute value)	Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
heart rate (minute value)	Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)

Collaborators and Investigators

• Sponsor: Kafkas University
• Investigators: Principal Investigator: Ayşe Gül Parlak, PhD, Kafkas Üniversity; Study Chair: Mehtap Çullu, PhD, Muğla Üniversity; Study Chair: Zeliha Özkaraca, MSc, muğla provincial directorate of national education

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): February 15, 2025

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KAU-SBF-AGP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No