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OpenTrials
Active, not recruiting

NCT Number: NCT07825974

Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

Hemodialysis patients experience recurrent pain and anxiety during arteriovenous fistula cannulation, which can negatively affect treatment adherence and quality of life. Non-pharmacological interventions such as deep breathing relaxation and aromatherapy have shown potential in reducing procedure-related pain and anxiety. Lemongrass (Cymbopogon citratus) essential oil contains citral and other compounds with reported anxiolytic and analgesic properties. However, the combined effect of deep breathing relaxation with lemongrass aromatherapy has not been well studied in this population. This study will recruit hemodialysis patients who require arteriovenous fistula cannulation. The intervention group will receive deep breathing relaxation instruction combined with lemongrass aromatherapy inhalation before needle insertion. The control group will receive standard care. The primary outcomes are pain intensity measured by the Visual Analogue Scale (VAS) and anxiety measured by the State-Trait Anxiety Inventory (STAI). Secondary outcomes include physiological parameters (heart rate, blood pressure) and patient satisfaction. Data will be collected during three consecutive hemodialysis sessions to assess consistency of effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • (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

Treatment and study plan

Deep Breathing Relaxation

Behavioral

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

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.

Primary outcomes

  1. Pain Intensity Measured by Visual Analogue Scale (VAS)

    Time frame: Immediately after needle insertion, during three consecutive hemodialysis sessions

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

  2. Anxiety Measured by State-Trait Anxiety Inventory (STAI)

    Time frame: Before and immediately after needle insertion

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

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Effect of Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain During Needle Insertion and Anxiety in Hemodialysis Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 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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