Muscle CrampsNCT04874857
The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp
A study testing Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. and Baby oil in people with Muscle Cramps and Aromatherapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled and single-blind study consisting of qualitative and quantitative stages to evaluate the effect of aromatherapy massage on cramp frequency, cramp pain severity and quality of life in crampy hemodialysis (HD) patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Cramps, Aromatherapy, Hemodialysis
- What is being tested?
- Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. and Baby oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2020to 28 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years old,
- Able to answer questions and communicate,
- Is conscious and does not have a mental problem,
- Speaks Turkish,
- No hearing, sight or speech impairment,
- Having HD treatment for at least six months,
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- Receiving three HD treatment sessions a week,
- Dialysis with bicarbonate dialysate,
- Kt / V value> 1.2,
- Having a constant dry weight for the last month,
- Experiencing cramps during hemodialysis sessions or at any other time and who scored at least three or more when the severity of cramp pain was evaluated with the Visual Analog Scale (VAS),
- Patients who are not allergic to the oils used for massage will be included in the study.
Who cannot join
- Pregnant and breastfeeding women,
- Cancer,
- Diabetic foot,
- Lower extremity amputation,
- Having neurological diseases such as epilepsy, parkinson, dementia, Alzheimer,
- Those with paraplegia,
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- The lower leg is in a size that prevents the application of massage,
- had surgery in the last three months,
- Loss of sensation more than 50% due to neuropathy due to various reasons,
- Open wound in the foot and lower leg, infection, necrosis, fracture / fracture suspected, soft tissue damage, burn,
- Peripheral vascular disease,
- Deep vein thrombosis,
- Receiving treatment to prevent cramping,
- Having a severe electrolyte (such as potassium, magnesium, calcium) disorder in blood values,
- Patients using any of the complementary and integrated methods in the last month will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp on Cramp Frequency, Severity of Pain and Quality of Life
This study is a randomized controlled and single-blind study consisting of qualitative and quantitative stages to evaluate the effect of aromatherapy massage on cramp frequency, cramp pain severity and quality of life in crampy hemodialysis (HD) patients.
Read the detailed description
Data-collecting interviewers are blind to which patients are in which group. The days and sessions of the groups were randomly determined after patients meeting the research criteria of the intervention, placebo control, and control groups were ranked.
The population of the study consists of 566 patients treated in institutions that allow the research to be conducted.
145 patients participated in the study and the study was terminated with 94 patients. In the study, aromatherapy massage was applied to the intervention group, baby oil massage was applied to the placebo control group, while no application was made to the control group other than routine care. Aromatherapy massage to the intervention group; It was applied with a mixture of 7% lavender, rosemary and marjoram essential oils.
Dependent Variables: Cramp frequency, mean cramp pain severity, and quality of life scale total score.
Independent Variables: age, gender, body mass index, marital status, educational status, income level, sociodemographic characteristics such as smoking and alcohol use, characteristics related to the diagnosis-treatment process, concomitant diseases and laboratory parameters.
Research data; Intervention and Placebo Group Situation Evaluation Chart, Personal Information Form, Personal Interview Form, Visual Analogue Scale, Quality of Life Index Dialysis Version-III and Control, Intervention and Placebo Group Monitoring Chart were collected. The qualitative data obtained in the study were evaluated using descriptive and content analysis methods. Statistical Package for the Social Sciences program was used to evaluate the quantitative data. A value of p < 0.05 will be accepted as statistical significance criterion. In order to carry out the study, the necessary Academic Committee decision, Ethics Committee approval (dated 11 November 2020 and numbered 13) and institutional permission were obtained. The individuals included in the study were informed about the purpose of the study.
- Conditions
- Muscle Cramps, Aromatherapy, Hemodialysis, Quality of Life, Pain
- Being tested
- Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L., Baby oil
- Medical subject headings
- Muscle Cramp, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.Other
Massage application
Baby oilOther
Massage application
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Aromatherapy group) | Experimental | With a mixture of Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. essential oils, the foot and lower leg will be massaged for three sessions a week for 30 minutes in each session for four weeks. Receives: Other: Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. |
| Placebo group | Experimental | The foot and lower leg will be massaged with baby oil for four weeks, three sessions a week, 30 minutes in each session. Receives: Other: Baby oil |
| Control group | No intervention | No application will be made in addition to standard HD treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scala (VAS)
The widespread use of VAS, which has been used in the research of subjective concepts from past years to the present, has been realized after in 1969. This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. The patient marks the severity of the cramp he is experiencing at that moment, and the starting and ending points of the scale as criteria. A VAS value between 1-3 means "mild pain", between 4-6 means "moderate pain", and a value between 7-10 means "severe pain". Participants will mark the scale each time they experience a cramp.
Measured: During 1 month
Secondary outcomes (1)
Quality of Life Index Dialysis Version - III
"Quality of Life Index Dialysis Version-3" was developed in 1985 in America. This scale consists of two parts measuring satisfaction from different areas of life and the importance of these areas for the individual, each part contains 34 items. In the satisfaction part of the 6-degree Likert-type scale consisting of 64 items, there are expressions from "very satisfied" to "not satisfied at all", and "very important to very unimportant" in the importance part. The scale has 4 sub-dimensions: health and function, socio-economic, psychological-beliefs, and family. The "translated total score" is obtained by combining the satisfaction and importance scores of the scale with a special formula.
Measured: At the first and last meeting in 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start25 Nov 2020
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle CrampsStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serife Cetin, TC Erciyes University
- Investigators
- Serife Cetin, PhD, Principal investigator, Kayseri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874857
- Sponsor's protocol ID
- Erciyes University
- Other IDs
- PhD student
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cetin S, Tasci S, Kocyigit I, Saz A. The Effect of Aromatherapy Massage on Cramp Frequency, Pain Intensity, and Quality of Life in Hemodialysis Patients With Muscle Cramps: A Randomized, Placebo-Controlled, Mixed Study. Holist Nurs Pract. 2026 Jul-Aug 01;40(4):258-272. doi: 10.1097/HNP.0000000000000715. Epub 2025 Jan 9.
PubMed 39787573
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Massage Applied to Hemodialysis Patients With Muscle Cramp on Cramp Frequency, Severity of Pain and Quality of Life
- ClinicalTrials.gov ID
- NCT04874857
- Acronym / sponsor ID
- Erciyes University
- Conditions
- Muscle Cramps, Aromatherapy, Hemodialysis, Quality of Life, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 6 May 2021 (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 study is a randomized controlled and single-blind study consisting of qualitative and quantitative stages to evaluate the effect of aromatherapy massage on cramp frequency, cramp pain severity and quality of life in crampy hemodialysis (HD) patients.
Detailed description
Data-collecting interviewers are blind to which patients are in which group. The days and sessions of the groups were randomly determined after patients meeting the research criteria of the intervention, placebo control, and control groups were ranked.
The population of the study consists of 566 patients treated in institutions that allow the research to be conducted.
145 patients participated in the study and the study was terminated with 94 patients. In the study, aromatherapy massage was applied to the intervention group, baby oil massage was applied to the placebo control group, while no application was made to the control group other than routine care. Aromatherapy massage to the intervention group; It was applied with a mixture of 7% lavender, rosemary and marjoram essential oils.
Dependent Variables: Cramp frequency, mean cramp pain severity, and quality of life scale total score.
Independent Variables: age, gender, body mass index, marital status, educational status, income level, sociodemographic characteristics such as smoking and alcohol use, characteristics related to the diagnosis-treatment process, concomitant diseases and laboratory parameters.
Research data; Intervention and Placebo Group Situation Evaluation Chart, Personal Information Form, Personal Interview Form, Visual Analogue Scale, Quality of Life Index Dialysis Version-III and Control, Intervention and Placebo Group Monitoring Chart were collected. The qualitative data obtained in the study were evaluated using descriptive and content analysis methods. Statistical Package for the Social Sciences program was used to evaluate the quantitative data. A value of p < 0.05 will be accepted as statistical significance criterion. In order to carry out the study, the necessary Academic Committee decision, Ethics Committee approval (dated 11 November 2020 and numbered 13) and institutional permission were obtained. The individuals included in the study were informed about the purpose of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Aromatherapy group) | Experimental | Other: Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.With a mixture of Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. essential oils, the foot and lower leg will be massaged for three sessions a week for 30 minutes in each session for four weeks. |
| Placebo group | Experimental | Other: Baby oilThe foot and lower leg will be massaged with baby oil for four weeks, three sessions a week, 30 minutes in each session. |
| Control group | No intervention | –No application will be made in addition to standard HD treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Above 18 years old,
- Able to answer questions and communicate,
- Is conscious and does not have a mental problem,
- Speaks Turkish,
- No hearing, sight or speech impairment,
Key exclusion criteria (15 listed)
- Pregnant and breastfeeding women,
- Cancer,
- Diabetic foot,
- Lower extremity amputation,
- Having neurological diseases such as epilepsy, parkinson, dementia, Alzheimer,
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 |
|---|---|---|
| Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.Massage application | Other | Intervention group (Aromatherapy group) |
| Baby oilMassage application | Other | Placebo group |
Primary outcome
Visual Analog Scala (VAS)
Time frame: During 1 month
The widespread use of VAS, which has been used in the research of subjective concepts from past years to the present, has been realized after in 1969. This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. The patient marks the severity of the cramp he is experiencing at that moment, and the starting and ending points of the scale as criteria. A VAS value between 1-3 means "mild pain", between 4-6 means "moderate pain", and a value between 7-10 means "severe pain". Participants will mark the scale each time they experience a cramp.
1 secondary outcome
Quality of Life Index Dialysis Version - III
Time frame: At the first and last meeting in 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 39787573Cetin S, Tasci S, Kocyigit I, Saz A. The Effect of Aromatherapy Massage on Cramp Frequency, Pain Intensity, and Quality of Life in Hemodialysis Patients With Muscle Cramps: A Randomized, Placebo-Controlled, Mixed Study. Holist Nurs Pract. 2026 Jul-Aug 01;40(4):258-272. doi: 10.1097/HNP.0000000000000715. Epub 2025 Jan 9.
- Individual participant dataSharing planned: No
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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.
Serife Cetin, PhD principal investigator
Kayseri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L. and Baby oil in people with Muscle Cramps and Aromatherapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 12 inclusion and 15 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: finished, as of the sponsor's last update on 10 Jan 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scala (VAS) (time frame: During 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04874857, which also lists 1 linked publication.
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 10 Jan 2023.