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

NCT06645457 | Completed

• 1 other identifier: KAU-SBF-AGP-03
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopy; Breathing Exercises; Cognitive Therapy; Stress; Anxiety; Physiological Parameters

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• systolic blood pressure (mm/Hg)

  At the beginning and end of the 20-minute stress ball or breathing exercise intervention (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)

• SpO2-peripheral oxygen saturation (%)

  At the beginning and end of the 20-minute stress ball or breathing exercise intervention (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)

• heart rate (minute value)

  At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)

Study Arms (3)

stress ball

EXPERIMENTAL

group applying the stress ball for 20 minute before endoscopy

Other: stress ball

4-7-8 breathing technique

EXPERIMENTAL

group applying the 4-7-8 breathing technique for 6 sets before endoscopy

Other: 4-7-8 breathing technique

Control group

NO INTERVENTION

The group in which no intervention was performed before endoscopy and routine care was given

Interventions

stress ball OTHER

Patients squeeze the stress ball

stress ball

4-7-8 breathing technique OTHER

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.

4-7-8 breathing technique

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Mehtap ÇULLU

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ayşe Gül Parlak, PhD

  Kafkas Üniversity

  PRINCIPAL INVESTIGATOR

• Mehtap Çullu, PhD

  Muğla Üniversity

  STUDY CHAIR

• Zeliha Özkaraca, MSc

  muğla provincial directorate of national education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: October 16, 2024
• Study Start: January 10, 2025
• Primary Completion: January 30, 2025
• Study Completion: February 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)