Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy

NCT07702175 | Not Yet Recruiting

• 1 other identifier: 14.05.2026-E.302189
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effect of the 4-7-8 breathing technique, applied during Electromyography (EMG) for the diagnosis of diabetic peripheral neuropathy, on the pain and anxiety levels experienced by patients with Type 2 diabetes. EMG is a diagnostic method that can cause pain and anxiety in patients. Due to the limited number of non-pharmacological studies in the literature focusing on pain management in diabetic individuals during this process, the investigation of the effectiveness of the 4-7-8 breathing technique, which strengthens parasympathetic activity, using a randomized controlled design constitutes the unique value of this study. The research will be conducted in a randomized controlled experimental design. The sample will consist of individuals diagnosed with Type 2 diabetes who are referred to the EMG outpatient clinic of Osmaniye Training and Research Hospital. The experimental group will receive training on the 4-7-8 breathing technique and will be instructed to apply it during the procedure, while the control group will receive the routine clinical protocol. Data will be collected using the Patient Identification Form, Numerical Rating Scale (NRS), State Anxiety Scale (SAS), and Neuropathic Pain Questionnaire (DN4). The study expects the 4-7-8 breathing technique to significantly reduce pain and anxiety levels. It aims to improve the comfort of diabetic patients during procedures and the quality of diagnostic data, and to introduce this method into the literature as a low-cost and independent pain management strategy in nursing care. Furthermore, the study aligns with the "Health and Quality of Life" (SDG3) goal, which is part of the Sustainable Development Goals set by the United Nations. SDG3 offers a comprehensive global framework aimed at ensuring healthy living for all individuals and promoting well-being at all ages; it includes increasing access to health services, improving the quality of care, and strengthening patient-centered approaches.

Conditions

Diabetic Neuropathies; Diabetes Mellitus (Type 2); Pain; Anxiety

Keywords

Type 2 Diabetes; Electromyography; 4-7-8 Breathing Technique; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Numeric Rating Scale (NRS) will be used to assess the subjective pain levels experienced by patients during the Electromyography (EMG) procedure. The scale ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.

  Pain levels will be assessed at multiple specific time points throughout the study: baseline (immediately before the EMG procedure), during the EMG procedure,and immediately following the completion of the EMG procedure

Secondary Outcomes (1)

• State Anxiety Inventory

  Anxiety levels will be assessed at two distinct time points: baseline (immediately before the EMG procedure, prior to random assignment and breathing training) and immediately following the completion of the EMG procedure

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will receive training on the 4-7-8 breathing technique and will actively practice this controlled breathing cycle throughout the diagnostic Electromyography (EMG) procedure.

Behavioral: 4-7-8 Breathing Technique

Control Group

NO INTERVENTION

Participants in this group will undergo the standard routine diagnostic Electromyography (EMG) procedure without any breathing technique intervention.

Interventions

4-7-8 Breathing Technique BEHAVIORAL

A controlled breathing exercise involving inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling completely for 8 seconds.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-70 years who:
• Have been diagnosed with Type 2 DM for at least one year,
• Have diabetic peripheral neuropathy and are taking medications with a DN4 score \>3,
• Are cooperative and can communicate in Turkish. • Do not have orthopedic or surgical contraindications that would prevent them from undergoing testing.

You may not qualify if:

• Individuals with severe autonomic neuropathy findings (resting tachycardia, etc.),
• Individuals with respiratory system diseases that prevent deep breathing, such as COPD and asthma,
• Individuals with active infection or compromised skin integrity (dryness, cracks, open wounds, lesions, etc.) in the area where EMG will be performed,
• Individuals with a mass (tumor, cystic formation, etc.) in the anatomical area where EMG will be performed,
• Individuals with varicose veins (signs of venous insufficiency) in the anatomical area where EMG will be performed,
• Individuals with edema in the area where EMG will be performed that may affect the quality of electrophysiological recordings,
• Individuals with a dialysis catheter, central venous catheter, or implanted venous port,
• Individuals who have used analgesics (painkillers) within 24 hours prior to the procedure,
• Individuals who cannot follow breath commands due to hearing or visual impairment. • Individuals with any muscle disease,
• Individuals receiving chemotherapy/radiotherapy treatment at any time,
• Individuals who have undergone knee, hip, or lumbar surgery,
• Pregnant women,
• Individuals with any inflammatory rheumatic disease,
• Patients with pacemakers or ICDs,
• Individuals with chronic kidney failure

Sponsors & Collaborators

• Nurgül Gün: lead

Study Sites (1)

Osmaniye Training and Research Hospital

Osmaniye, Osmaniye, 80000, Turkey (Türkiye)

Location

Related Publications (7)

• Slack D, Nelson L, Patterson D, Burns S, Hakimi K, Robinson L. The feasibility of hypnotic analgesia in ameliorating pain and anxiety among adults undergoing needle electromyography. Am J Phys Med Rehabil. 2009 Jan;88(1):21-9. doi: 10.1097/PHM.0b013e31818e00bd.

  PMID: 18971768 BACKGROUND

• Yeung AWK, Wong NSM. The Historical Roots of Visual Analog Scale in Psychology as Revealed by Reference Publication Year Spectroscopy. Front Hum Neurosci. 2019 Mar 12;13:86. doi: 10.3389/fnhum.2019.00086. eCollection 2019.

  PMID: 30914939 BACKGROUND

• Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.

  PMID: 27999003 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Eskimez Z, Keskin A, Kurt E, Ozbarlas HS, Tekin M, Kundakci B. 4-7-8 Breathing Techniques Make It Possible to Reduce Pain Associated With Total Knee Arthroplasty: A New Technique in Respiratory Exercises. J Perianesth Nurs. 2026 Feb;41(1):48-53. doi: 10.1016/j.jopan.2025.04.009. Epub 2025 Jul 30.

  PMID: 40742342 BACKGROUND

• Choudhury AA, Devi Rajeswari V. Gestational diabetes mellitus - A metabolic and reproductive disorder. Biomed Pharmacother. 2021 Nov;143:112183. doi: 10.1016/j.biopha.2021.112183. Epub 2021 Sep 21.

  PMID: 34560536 BACKGROUND

• Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.

  PMID: 36480101 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Nurgül GÜN, MSc, RN

CONTACT

+90 553 869 46 78; nurgul.gun@hku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: LECTURER

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)