- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07616869
Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety
Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety During Blood Collection: Breathing Exercises and Stress Ball
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Yunusemre
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Manisa, Yunusemre, Turkey (Türkiye), 45140
- Kıvan ÇEVİK KAYA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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,
- 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
Exclusion Criteria:
- 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
Study Plan
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 |
Intervention / Treatment |
|---|---|
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No Intervention: Control
No intervention
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Experimental: Stress ball
Stress balls were provided to the individuals in this group during routine venous blood draws.
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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.
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Experimental: Breathing exercise
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety
Time Frame: day 1
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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.
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day 1
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Acute Pain
Time Frame: day 1
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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.
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day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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blood pressure
Time Frame: Day 1
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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.
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Day 1
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Pulse
Time Frame: Day 1
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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.
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Day 1
|
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oxygen saturation
Time Frame: Day 1
|
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.
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Day 1
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBU-K-CEVIK-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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