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

Not Applicable

Recruiting

• Conditions: Endoscopy; Breathing Exercises; Cognitive Therapy; Stress; Anxiety; Physiological Parameters

• Registration Number: NCT06645457
• Lead Sponsor: Kafkas University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-07-02
• Status Verified: 2024-10
• Study Start: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)	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).
State-Trait Anxiety İnventory	At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mehtap ÇULLU; 🇹🇷 Muğla, Turkey