EndoscopyNCT06645457
The Effect of Stress Ball and 4-7-8 Breathing Technique on Fear, Anxiety and Physiological Parameters
A study testing stress ball and 4-7-8 breathing technique in people with Endoscopy and Breathing Exercises, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Endoscopy, Breathing Exercises, Cognitive Therapy
- What is being tested?
- stress ball and 4-7-8 breathing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Endoscopy, Breathing Exercises, Cognitive Therapy, Stress, Anxiety, Physiological Parameters
- Being tested
- stress ball, 4-7-8 breathing technique
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballOther
Patients squeeze the stress ball
4-7-8 breathing techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| stress ball | Experimental | group applying the stress ball for 20 minute before endoscopy Receives: Other: stress ball |
| 4-7-8 breathing technique | Experimental | group applying the 4-7-8 breathing technique for 6 sets before endoscopy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
Measurements are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).
Measured: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
Measured: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
Measured: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
Measured: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
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).
Measured: At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start10 Jan 2025
- Primary completion10 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Gul Parlak, Kafkas University
- Investigators
- Ayşe Gül Parlak, PhD, Principal investigator, Kafkas ÜniversityMehtap Çullu, PhD, Study chair, Muğla ÜniversityZeliha Özkaraca, MSc, Study chair, muğla provincial directorate of national education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645457
- Sponsor's protocol ID
- KAU-SBF-AGP-03
- Status last verified
- May 2026
- First submitted
- 2 Jul 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06645457
- Acronym / sponsor ID
- KAU-SBF-AGP-03
- Conditions
- Endoscopy, Breathing Exercises, Cognitive Therapy, Stress, Anxiety, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stress ball | Experimental | Other: stress ballgroup applying the stress ball for 20 minute before endoscopy |
| 4-7-8 breathing technique | Experimental | Other: 4-7-8 breathing techniquegroup applying the 4-7-8 breathing technique for 6 sets before endoscopy |
| Control group | No intervention | –The group in which no intervention was performed before endoscopy and routine care was given |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress ballPatients squeeze the stress ball | Other | stress ball |
| 4-7-8 breathing techniquebreathing 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. | Other | 4-7-8 breathing technique |
Primary outcome
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).
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress ball and 4-7-8 breathing technique in people with Endoscopy and Breathing Exercises, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.