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NCT Number: NCT06645457

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

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.

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Key information

Conditions

Endoscopy Anxiety Anxiety Disorders Breathing Exercises Cognitive Therapy Mental Disorders Physiological Parameters Stress

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mehtap ÇULLU

Muğla, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Stress ball

Other

Patients squeeze the 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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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).

  2. State-Trait Anxiety İnventory

    Time frame: 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 outcomes

  1. systolic blood pressure (mm/Hg)

    Time frame: 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).

  2. diastolic blood pressure (mm/Hg)

    Time frame: 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).

  3. SpO2-peripheral oxygen saturation (%)

    Time frame: 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).

  4. Respiratory rate (minute value)

    Time frame: 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).

  5. heart rate (minute value)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kafkas University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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