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Completed

NCT Number: NCT07616869

Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety

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.

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Key information

Conditions

Stress Acute Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kıvan ÇEVİK KAYA

Manisa, Yunusemre, 45140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

stress ball

Behavioral

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 exercises

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. blood pressure

    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.

  2. Pulse

    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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety During Blood Collection: Breathing Exercises and Stress Ball

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 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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