ClinicalTrials.gg
Active, not recruitingNCT07825974Updated Sep 17, 2026

Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain

An interventional study of Deep Breathing Relaxation and Lemongrass Aromatherapy in Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety, sponsored by University of Baghdad. Active, not recruiting at 1 site in Iraq. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Primary conditionKidney Failure, ChronicRegistry: Renal Insufficiency, ChronicReclassifiedWhy we changed it
Registry
Renal Insufficiency, Chronic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Kidney Failure, Chronic
Why
  1. The study's listed conditions name Kidney Failure, Chronic, a narrower term within Renal Insufficiency, Chronic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Baghdad · Not applicable, Interventional, and Supportive care

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Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

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

Keywords

  • Deep Breathing Relaxation
  • Lemongrass Aromatherapy
  • Needle Insertion
  • Arteriovenous Fistula
  • Hemodialysis
03

In context

Kidney Failure, Chronic Reclassified

2,109 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's planned enrollment of 190 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

University of Baghdad is the lead sponsor of 171 studies on the registry; 70 are open to participants now.

Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency, Chronic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    expermental

    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

  • No intervention
    control

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

Interventions

  • BehavioralDeep Breathing Relaxation

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

  • OtherLemongrass Aromatherapy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    Time frame: Before and immediately after needle insertion

07

Study locations

1 site
  • Ministry of Health
    Al Muthanná, Samawa 61001, Iraq
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Oct 2026, 2 months after the start.

Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 2 months is below that.

Counting every sponsor, half of 425 studies reached it within 22 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2026
First posted
Sep 17, 2026
StartActual
Aug 11, 2026
Primary completionEst.
Oct 11, 2026
CompletionEst.
Oct 15, 2026
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07825974
Responsible party
Maitham abed Shawwat (Dr. Maitham Abed Shawwat (PhD), University of Baghdad) — Principal investigator
First posted
Sep 17, 2026
Start date
Aug 11, 2026
Primary completion
Oct 11, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
Sep 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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