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

May 19, 2026 updated by: Ayse Gul Parlak, Kafkas University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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.
At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kafkas University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşe Gül Parlak, PhD, Kafkas University
  • Study Chair: Mehtap Çullu, PhD, Muğla Üniversity
  • Study Chair: Zeliha Özkaraca, MSc, muğla provincial directorate of national education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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