Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; AnxietyNCT07825974
Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain
A study testing Deep Breathing Relaxation and Lemongrass Aromatherapy in people with Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety
- What is being tested?
- Deep Breathing Relaxation and Lemongrass Aromatherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteIraq
- Study dates
- 11 Aug 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain During Needle Insertion and Anxiety in Hemodialysis Patients
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.
- Being tested
- Deep Breathing Relaxation, Lemongrass Aromatherapy
- Keywords
- Deep Breathing Relaxation, Lemongrass Aromatherapy, Needle Insertion, Arteriovenous Fistula, Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Pain, Anxiety Disorders, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Breathing RelaxationBehavioural
Participants are instructed to perform slow, deep diaphragmatic breathing at a controlled rate for a specified duration before needle insertion.
Lemongrass AromatherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Deep Breathing Relaxation; Other: Lemongrass Aromatherapy |
| control | No intervention | Participants receive standard care and routine needle insertion procedure without the study interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and immediately after needle insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start11 Aug 2026
- Primary completion11 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maitham abed Shawwat, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825974
- Sponsor's protocol ID
- UNBaghdad
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain During Needle Insertion and Anxiety in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07825974
- Acronym / sponsor ID
- UNBaghdad
- Keywords
- Deep Breathing Relaxation, Lemongrass Aromatherapy, Needle Insertion, Arteriovenous Fistula, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| expermental | Experimental | Behavioral: Deep Breathing Relaxation, Other: Lemongrass AromatherapyParticipants receive deep breathing relaxation instruction combined with lemongrass essential oil inhalation for a specified duration before each needle insertion, across three hemodialysis sessions. |
| control | No intervention | –Participants receive standard care and routine needle insertion procedure without the study interventions |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Breathing RelaxationParticipants are instructed to perform slow, deep diaphragmatic breathing at a controlled rate for a specified duration before needle insertion. | Behavioural | expermental |
| Lemongrass AromatherapyLemongrass 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. | Other | expermental |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety
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Virtual Reality-Guided Imagery in Hemodialysis Patients ( VRGI-HD )
End-Stage Kidney Disease (ESKD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Breathing Relaxation and Lemongrass Aromatherapy in people with Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measured by Visual Analogue Scale (VAS) (time frame: Immediately after needle insertion, during three consecutive hemodialysis sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.