Diabetes MellitusNCT06295900
The Effect of Aromatherapy Massage on Sleep Quality
A study testing Intervention 1 Group and Intervention 2 Group in people with Diabetes Mellitus and Respiratory Failure, run by Nilgün Erdoğan at 1 site in Turkey (Türkiye).
Trial summary
Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Respiratory Failure, Pneumonia
- What is being tested?
- Intervention 1 Group and Intervention 2 Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to Dec 2024
- 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
- 18 years of age and over,
- Conscious patients,
- Staying in intensive care for 24 hours or more,
- Those with stable hemodynamic status,
- Receiving O2 therapy,
- Intubated patients, patients who have passed 24 hours after being extubated,
- Those whose saturation level is 85 and above
Who cannot join
- Patients with peripheral neuropathy or quadriplegia,
- Patients with open wounds on their body,
- Patients receiving analgesia and sedation infusion,
- Patients who are sedated,
- Patients in delirium,
- Patients with allergies detected before starting the application
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ömer Halisdemir University Training and Research Hospital
Niğde, 51100
nilgun erdogan, researcher, 5312599220, nilgunerdogan37@gmail.com
About this study
Official title: The Effect of Aromatherapy Massage Applied to Intensive Care Patients on Sleep Quality
Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality.
- Being tested
- Intervention 1 Group, Intervention 2 Group, Placebo Control Group
- Keywords
- intensive care, sleep quality, aromatherapy massage
- Medical subject headings
- Diabetes Mellitus, Respiratory Insufficiency, Pneumonia, Respiration Disorders, Ischemic Stroke, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1 GroupOther
20 patients were included in this group and aromatherapy was applied once a day, for a total of 30 minutes, for three days, with a mixture of lavender, medicinal chamomile, and neroli oil (2 drops of lavender oil, 4 drops of medicinal chamomile, 6 drops of neroli oil in 20 ml of sweet almond oil). Massage is planned.
Intervention 2 GroupOther
It is planned to include 20 patients in this group and perform an aromatherapy massage with a mixture of only lavender oil (12 drops of lavender oil in 20 ml of sweet almond oil), once a day for three days, for a total of 30 minutes.
Placebo Control GroupOther
It is planned to include 20 patients in this group and perform an aromatherapy massage with only almond oil (20 ml sweet almond oil) mixture, once a day for three days, for a total of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 Group | Active comparator | In this group, application is made with chamomile, lavender and neroli oil. Receives: Other: Intervention 1 Group |
| Intervention 2 Group | Sham comparator | In this group, application is made with lavender oil. Receives: Other: Intervention 2 Group |
| Placebo Control Group | Placebo comparator | In this group, application is made only with almond oil. Receives: Other: Placebo Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Introduction Form
In the "Patient Introduction Form" prepared by the researcher based on the literature in order to obtain information about the characteristics of the patients who will constitute the sample, the patients' medical diagnosis, age, gender, chronic diseases, length of stay in intensive care, use of analgesic, sedative and hypnotic drugs used, normal sleep hours at night were included. There are questions about (sleep duration, daytime sleep, sleep hours, sleep aids used, etc.).
Measured: 1 year
Secondary outcomes (1)
Patient Follow-up Form
The patient follow-up form was created by the researcher and will include the visual comparison sleep scale follow-up results, the effects of the application (whether side effects develop, its effect on the application area, the patient's condition, etc.) and the dosage of the hypnotic and sedative drugs the patient took in the intensive care unit during the study. The sleep score results of the patients will be recorded on the patient follow-up form by the nurses who collected the data of the study the morning after the application (08), and the effects of the application will also be recorded by the researcher.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start5 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Model description
- It will be conducted as a randomized controlled single-blind study
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nilgün Erdoğan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nilgün Erdoğan, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295900
- Sponsor's protocol ID
- 19.10.2023/63
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Massage Applied to Intensive Care Patients on Sleep Quality
- ClinicalTrials.gov ID
- NCT06295900
- Acronym / sponsor ID
- 19.10.2023/63
- Keywords
- intensive care, sleep quality, aromatherapy massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Nilgün ErdoğanUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Mar 2024 (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.
Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- It will be conducted as a randomized controlled single-blind study
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 Group | Active comparator | Other: Intervention 1 GroupIn this group, application is made with chamomile, lavender and neroli oil. |
| Intervention 2 Group | Sham comparator | Other: Intervention 2 GroupIn this group, application is made with lavender oil. |
| Placebo Control Group | Placebo comparator | Other: Placebo Control GroupIn this group, application is made only with almond oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age and over,
- Conscious patients,
- Staying in intensive care for 24 hours or more,
- Those with stable hemodynamic status,
- Receiving O2 therapy,
Key exclusion criteria (6 listed)
- Patients with peripheral neuropathy or quadriplegia,
- Patients with open wounds on their body,
- Patients receiving analgesia and sedation infusion,
- Patients who are sedated,
- Patients in delirium,
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 |
|---|---|---|
| Intervention 1 Group20 patients were included in this group and aromatherapy was applied once a day, for a total of 30 minutes, for three days, with a mixture of lavender, medicinal chamomile, and neroli oil (2 drops of lavender oil, 4 drops of medicinal chamomile, 6 drops of neroli oil in 20 ml of sweet almond oil). Massage is planned. | Other | Intervention 1 Group |
| Intervention 2 GroupIt is planned to include 20 patients in this group and perform an aromatherapy massage with a mixture of only lavender oil (12 drops of lavender oil in 20 ml of sweet almond oil), once a day for three days, for a total of 30 minutes. | Other | Intervention 2 Group |
| Placebo Control GroupIt is planned to include 20 patients in this group and perform an aromatherapy massage with only almond oil (20 ml sweet almond oil) mixture, once a day for three days, for a total of 30 minutes. | Other | Placebo Control Group |
Primary outcome
Patient Introduction Form
Time frame: 1 year
In the "Patient Introduction Form" prepared by the researcher based on the literature in order to obtain information about the characteristics of the patients who will constitute the sample, the patients' medical diagnosis, age, gender, chronic diseases, length of stay in intensive care, use of analgesic, sedative and hypnotic drugs used, normal sleep hours at night were included. There are questions about (sleep duration, daytime sleep, sleep hours, sleep aids used, etc.).
1 secondary outcome
Patient Follow-up Form
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
Ömer Halisdemir University Training and Research Hospital
Niğde, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 Group and Intervention 2 Group in people with Diabetes Mellitus and Respiratory Failure, run by Nilgün Erdoğan 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Introduction Form (time frame: 1 year). 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 6 Mar 2024.