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

NCT07616869 | Completed

• 1 other identifier: MCBU-K-CEVIK-005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress; Pain, Acute

Keywords

Pain; anxiety; breathing exercises; stress ball

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  day 1

Secondary Outcomes (3)

• blood pressure

  Day 1

• Pulse

  Day 1

• oxygen saturation

  Day 1

Study Arms (3)

Control

NO INTERVENTION

No intervention

Stress ball

EXPERIMENTAL

Stress balls were provided to the individuals in this group during routine venous blood draws.

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.

Behavioral: breathing exercises

Interventions

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.

Stress ball

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.

Breathing exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Kıvan ÇEVİK KAYA

Manisa, Yunusemre, 45140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Pain; Anxiety Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data were entered into the computer by the researcher as Group A, Group B, and Group C, without using the terms "intervention group" or "control group," thereby ensuring a blinded approach for statistical analysis. Data analysis was conducted by a statistician other than the person who performed the randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The sample consisted of 90 patients who comprising 30 breathing exercise, 30 stress ball, and 30 control groups.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: June 1, 2026
• Study Start: March 1, 2025
• Primary Completion: March 30, 2025
• Study Completion: February 28, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)