Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain

NCT07825974 | Active Not Recruiting

• 1 other identifier: UNBaghdad
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effect of deep breathing relaxation combined with lemongrass aromatherapy on pain during arteriovenous fistula needle insertion and anxiety in hemodialysis patients. Participants will be randomly assigned to receive either the combined relaxation intervention or standard care. Pain intensity and anxiety levels will be assessed before and after needle insertion.

Conditions

Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety

Keywords

Deep Breathing Relaxation; Lemongrass Aromatherapy; Needle Insertion; Arteriovenous Fistula; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Pain Intensity Measured by Visual Analogue Scale (VAS)

  VAS score (0-100 mm, where 0 = no pain and 100 = worst imaginable pain) assessed immediately after needle insertion.

  Immediately after needle insertion, during three consecutive hemodialysis sessions

• Anxiety Measured by State-Trait Anxiety Inventory (STAI)

  State anxiety subscale score of the STAI, a validated 20-item self-report instrument. Higher scores indicate greater anxiety.

  Before and immediately after needle insertion

Study Arms (2)

expermental

EXPERIMENTAL

Participants receive deep breathing relaxation instruction combined with lemongrass essential oil inhalation for a specified duration before each needle insertion, across three hemodialysis sessions.

Behavioral: Deep Breathing Relaxation; Other: Lemongrass Aromatherapy

control

NO INTERVENTION

Participants receive standard care and routine needle insertion procedure without the study interventions

Interventions

Deep Breathing Relaxation BEHAVIORAL

Participants are instructed to perform slow, deep diaphragmatic breathing at a controlled rate for a specified duration before needle insertion.

expermental

Lemongrass Aromatherapy OTHER

Lemongrass essential oil (diluted to 10% concentration) is applied to a cotton pad placed at a standardized distance from the participant for inhalation during the relaxation period.

expermental

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• receiving hemodialysis three times per week for at least 3 months; stable arteriovenous fistula or graft access; baseline pain score ≥4 on the Visual Analog Scale (VAS) during previous cannulation; ability to understand and perform breathing exercises; and willingness to participate.

You may not qualify if:

• (1)known allergy to lemongrass or essential oils; (2) history of asthma or severe respiratory disease; (3) cognitive impairment or psychiatric disorders; (4) use of analgesic or anxiolytic medications within 24 hours prior to intervention; (5) active infection or skin lesions at the access site; and (6) pregnancy or lactation

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Ministry of Health

Al Muthanná, Samawa, 61001, Iraq

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Pain; Anxiety Disorders; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Maitham Abed Shawwat (PhD)

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)