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CompletedNCT06645457Updated May 22, 2026

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

An interventional study of stress ball and 4-7-8 breathing technique in Endoscopy, Breathing Exercises and Cognitive Therapy, sponsored by Kafkas University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Kafkas University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 75 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Kafkas University is the lead sponsor of 32 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    stress ball

    group applying the stress ball for 20 minute before endoscopy

    Other: 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

  • No intervention
    Control group

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

Interventions

  • Otherstress ball

    Patients squeeze the stress ball

  • Other4-7-8 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.

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What researchers measure

Primary outcomes

  1. 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).

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

  2. 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.

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

Secondary outcomes

  1. 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).

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

  2. 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).

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

  3. 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).

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

  4. 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).

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

  5. 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).

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

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Study locations

1 site
  • Mehtap ÇULLU
    Muğla, 48000, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06645457
Lead sponsor
Kafkas University
Responsible party
Ayse Gul Parlak (Assistant professor, Kafkas University) — Principal investigator
First posted
Oct 16, 2024
Start date
Jan 10, 2025
Primary completion
Feb 10, 2025
Completion
Feb 15, 2025
Last update
May 22, 2026

Study contacts

Ayşe Gül Parlak, PhD
principal investigator · Kafkas Üniversity
Mehtap Çullu, PhD
study chair · Muğla Üniversity
Zeliha Özkaraca, MSc
study chair · muğla provincial directorate of national education

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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