StressNCT07616869
Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety
A study testing stress ball and breathing exercises in people with Stress and Pain, Acute, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to determine the effect of distraction techniques (breathing exercises and stress ball squeezing) applied to adults during blood collection on pain and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress, Pain, Acute
- What is being tested?
- stress ball and breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 28 Feb 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with no communication difficulties in terms of verbal, sensory, or visual aspects,
- who are oriented to person, time, and place,
- with an average pressure pain threshold of 8-16 pounds (lb),
- who have not taken any medication that would produce an analgesic effect within the
- last 6 hours prior to the blood draw,
- who do not have chronic or acute pain,
Show all 9Show fewer
- who do not have a condition that would impair their ability to feel pain (such as neuropathy),
- who are on the first day of their hospital admission,
- who are willing to participate in the study
Who cannot join
- Individuals who cannot undergo IV procedures in their forearm veins,
- who have been diagnosed with stroke due to cerebrovascular disease (CVD),
- who cannot actively use their hands (e.g., due to hemiplegia, fractures, or fistulas) for the breathing exercises group;
- individuals with respiratory diseases,
- those with conditions preventing them from performing breathing exercises,
- individuals who have never had blood drawn before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety During Blood Collection: Breathing Exercises and Stress Ball
Aim: This study was conducted to determine the effect of distraction techniques (breathing exercises and stress ball squeezing) applied to adults during blood collection on pain and anxiety. Materials and Methods: The sample consisted of 90 patients who applied for admission to the Physical Therapy and Rehabilitation Department of Turgutlu State Hospital between March 2025 and February 2026, comprising 30 breathing exercise, 30 stress ball, and 30 control groups. Data collection utilised the 'Demographic Characteristics Form', the 'State Anxiety Scale' and the 'Visual Anxiety Scale', the 'Visual Pain Scale'the 'Life Findings Form' to record life and the 'Informed Consent Form' were used . Descriptive statistical methods (number, percentage, median, mean, standard deviation), chi-square, Kolmogorov-Smirnov, Kruskal- Wallis, Wilcoxon, Bonferroni and Friedman were used when evaluating the data.
Read the detailed description
Inclusion Criteria for the Study Individuals who are 18-65 years of age, have no verbal, perceptual, or visual communication problems, have person-place-time orientation, have an average pressure pain threshold of 8-16 pounds (Lb), have not used any medication that would produce an analgesic effect in the last 6 hours before blood sampling, do not have chronic or acute pain, do not have a disease that would impair their ability to feel pain (such as neuropathy), are on their first day of hospitalization, and are willing to participate in the study were included.
Exclusion Criteria Individuals who cannot have IV procedures performed on their forearm veins, have a diagnosis of stroke from cerebrovascular diseases (CVD), cannot actively use their hands (hemiplegia, fracture, fistula, etc.), have respiratory tract disease, have a condition that prevents them from performing breathing exercises, and have never had blood drawn before were not included in the study.
- Conditions
- Stress, Pain, Acute
- Being tested
- stress ball, breathing exercises
- Keywords
- Pain, anxiety, breathing exercises, stress ball
- Medical subject headings
- Acute Pain, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballBehavioural
The stress ball, made of soft plastic and designed to be held comfortably in the hand, can be squeezed and released to return to its original shape; it measures 8-10 cm in diameter and has a smooth surface. The stress ball was given to the participant's hand on the side opposite the blood draw site, and they were instructed to squeeze and release it throughout the procedure. A separate stress ball was used for each participant. Information was provided about the Visual Analog Scale (VAS) to be used to measure pain levels during the blood draw, and the researcher asked about pain levels and anxiety levels during the procedure. After the blood draw was completed, participants were asked to complete the Vital Signs Form, the State Anxiety Scale, the Visual Anxiety Scale, and the Visual Pain Scale again.
breathing exercisesBehavioural
After individuals were taught breathing exercises, they were asked to begin the breathing exercises before the blood draw began. The individuals continued the breathing exercises during the blood draw, and the breathing exercises were stopped at the end of the procedure. Information was provided regarding the VAS to be used to measure pain levels during the blood draw, and the researcher asked about pain levels and anxiety levels during the procedure. After the blood draw was completed, participants were asked to complete the Vital Signs Form, the State Anxiety Scale, the Visual Anxiety Scale, and the Visual Pain Scale again.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Stress ball | Experimental | Stress balls were provided to the individuals in this group during routine venous blood draws. Receives: Behavioral: stress ball |
| Breathing exercise | Experimental | Breathing exercises were started before the blood draw began, and participants continued the breathing exercises during the blood draw; the breathing exercises were concluded at the end of the procedure. Receives: Behavioral: breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety of patient was assessed with State Anxiety Scale. The scale consists of 20 items and is a 4-point Likert-type scale (1 = "not at all," 2 = "somewhat," 3 = "very," 4 = "completely"). The individual is asked to assess how they feel "right now" and select the appropriate response based on the intensity of the emotions or behaviors described in the items. The total score on the State Anxiety Scale ranges from 20 to 80. The score categories are as follows: 0-19 points: no anxiety; 20-39 points: mild anxiety; 40-59 points: moderate anxiety; 60-79 points: severe anxiety; 80 points: panic. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 on the scale are reversed and used in the scoring. Higher scores indicate a higher level of anxiety, while lower scores indicate a lower level of anxiety. As scores increase, the level of anxiety also rises.
Measured: day 1
Acute Pain
Pain of patient was assessed with Visual Analogue Scale. The Visual Analogue Scale (VAS) may be preferred as an alternative to the Numerical Rating Scale. It is a 10-cm-long vertical or horizontal line with "No pain" written at one end and "Unbearable pain" at the other, used to measure the intensity of acute pain.
Measured: day 1
Secondary outcomes (3)
blood pressure
Physiologically, pain can lead to tachycardia, increased cardiac output, improved myocardial oxygenation, hypoxia, reduced lung ventilation, nausea, vomiting, and other such issues; psychologically, it can result in increased anxiety and stress levels, behavioral disorders, and sleep problems. This form was developed to record vital signs-including pulse, blood pressure, and oxygen saturation-measured in patients both before and immediately after the procedure.
Measured: Day 1
Pulse
Physiologically, pain can lead to tachycardia, increased cardiac output, improved myocardial oxygenation, hypoxia, reduced lung ventilation, nausea, vomiting, and other such issues; psychologically, it can result in increased anxiety and stress levels, behavioral disorders, and sleep problems. This form was developed to record vital signs-including pulse, blood pressure, and oxygen saturation-measured in patients both before and immediately after the procedure.
Measured: Day 1
oxygen saturation
Physiologically, pain can lead to tachycardia, increased cardiac output, improved myocardial oxygenation, hypoxia, reduced lung ventilation, nausea, vomiting, and other such issues; psychologically, it can result in increased anxiety and stress levels, behavioral disorders, and sleep problems. This form was developed to record vital signs-including pulse, blood pressure, and oxygen saturation-measured in patients both before and immediately after the procedure.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Mar 2025
- Primary completion30 Mar 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Model description
- The sample consisted of 90 patients who comprising 30 breathing exercise, 30 stress ball, and 30 control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616869
- Sponsor's protocol ID
- MCBU-K-CEVIK-005
- Status last verified
- May 2026
- First submitted
- 23 Mar 2026
- Last updated
- 1 Jun 2026
- Results posted
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety During Blood Collection: Breathing Exercises and Stress Ball
- ClinicalTrials.gov ID
- NCT07616869
- Acronym / sponsor ID
- MCBU-K-CEVIK-005
- Conditions
- Stress, Pain, Acute
- Keywords
- Pain, anxiety, breathing exercises, stress ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 1 Jun 2026 (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.
Aim: This study was conducted to determine the effect of distraction techniques (breathing exercises and stress ball squeezing) applied to adults during blood collection on pain and anxiety. Materials and Methods: The sample consisted of 90 patients who applied for admission to the Physical Therapy and Rehabilitation Department of Turgutlu State Hospital between March 2025 and February 2026, comprising 30 breathing exercise, 30 stress ball, and 30 control groups. Data collection utilised the 'Demographic Characteristics Form', the 'State Anxiety Scale' and the 'Visual Anxiety Scale', the 'Visual Pain Scale'the 'Life Findings Form' to record life and the 'Informed Consent Form' were used . Descriptive statistical methods (number, percentage, median, mean, standard deviation), chi-square, Kolmogorov-Smirnov, Kruskal- Wallis, Wilcoxon, Bonferroni and Friedman were used when evaluating the data.
Detailed description
Inclusion Criteria for the Study Individuals who are 18-65 years of age, have no verbal, perceptual, or visual communication problems, have person-place-time orientation, have an average pressure pain threshold of 8-16 pounds (Lb), have not used any medication that would produce an analgesic effect in the last 6 hours before blood sampling, do not have chronic or acute pain, do not have a disease that would impair their ability to feel pain (such as neuropathy), are on their first day of hospitalization, and are willing to participate in the study were included.
Exclusion Criteria Individuals who cannot have IV procedures performed on their forearm veins, have a diagnosis of stroke from cerebrovascular diseases (CVD), cannot actively use their hands (hemiplegia, fracture, fistula, etc.), have respiratory tract disease, have a condition that prevents them from performing breathing exercises, and have never had blood drawn before were not included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The sample consisted of 90 patients who comprising 30 breathing exercise, 30 stress ball, and 30 control groups.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Stress ball | Experimental | Behavioral: stress ballStress balls were provided to the individuals in this group during routine venous blood draws. |
| Breathing exercise | Experimental | Behavioral: breathing exercisesBreathing exercises were started before the blood draw began, and participants continued the breathing exercises during the blood draw; the breathing exercises were concluded at the end of the procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals with no communication difficulties in terms of verbal, sensory, or visual aspects,
- who are oriented to person, time, and place,
- with an average pressure pain threshold of 8-16 pounds (lb),
- who have not taken any medication that would produce an analgesic effect within the
- last 6 hours prior to the blood draw,
Key exclusion criteria (6 listed)
- Individuals who cannot undergo IV procedures in their forearm veins,
- who have been diagnosed with stroke due to cerebrovascular disease (CVD),
- who cannot actively use their hands (e.g., due to hemiplegia, fractures, or fistulas) for the breathing exercises group;
- individuals with respiratory diseases,
- those with conditions preventing them from performing breathing exercises,
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 ballThe stress ball, made of soft plastic and designed to be held comfortably in the hand, can be squeezed and released to return to its original shape; it measures 8-10 cm in diameter and has a smooth surface. The stress ball was given to the participant's hand on the side opposite the blood draw site, and they were instructed to squeeze and release it throughout the procedure. A separate stress ball was used for each participant. Information was provided about the Visual Analog Scale (VAS) to be used to measure pain levels during the blood draw, and the researcher asked about pain levels and anxiety levels during the procedure. After the blood draw was completed, participants were asked to complete the Vital Signs Form, the State Anxiety Scale, the Visual Anxiety Scale, and the Visual Pain Scale again. | Behavioural | Stress ball |
| breathing exercisesAfter individuals were taught breathing exercises, they were asked to begin the breathing exercises before the blood draw began. The individuals continued the breathing exercises during the blood draw, and the breathing exercises were stopped at the end of the procedure. Information was provided regarding the VAS to be used to measure pain levels during the blood draw, and the researcher asked about pain levels and anxiety levels during the procedure. After the blood draw was completed, participants were asked to complete the Vital Signs Form, the State Anxiety Scale, the Visual Anxiety Scale, and the Visual Pain Scale again. | Behavioural | Breathing exercise |
Primary outcome
Anxiety
Time frame: day 1
Anxiety of patient was assessed with State Anxiety Scale. The scale consists of 20 items and is a 4-point Likert-type scale (1 = "not at all," 2 = "somewhat," 3 = "very," 4 = "completely"). The individual is asked to assess how they feel "right now" and select the appropriate response based on the intensity of the emotions or behaviors described in the items. The total score on the State Anxiety Scale ranges from 20 to 80. The score categories are as follows: 0-19 points: no anxiety; 20-39 points: mild anxiety; 40-59 points: moderate anxiety; 60-79 points: severe anxiety; 80 points: panic. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 on the scale are reversed and used in the scoring. Higher scores indicate a higher level of anxiety, while lower scores indicate a lower level of anxiety. As scores increase, the level of anxiety also rises.
Acute Pain
Time frame: day 1
Pain of patient was assessed with Visual Analogue Scale. The Visual Analogue Scale (VAS) may be preferred as an alternative to the Numerical Rating Scale. It is a 10-cm-long vertical or horizontal line with "No pain" written at one end and "Unbearable pain" at the other, used to measure the intensity of acute pain.
3 secondary outcomes
blood pressure
Time frame: Day 1
Pulse
Time frame: Day 1
oxygen saturation
Time frame: Day 1
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 1 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 breathing exercises in people with Stress and Pain, Acute, run by Manisa Celal Bayar 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 9 inclusion and 6 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 1 Jun 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?
Anxiety (time frame: day 1). 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 1 Jun 2026.