Respiratory InsufficiencyNCT06295874
The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort
A study testing Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level in people with Respiratory Insufficiency and Pulmonary Disease, Chronic Obstructive, run by Nilgün Erdoğan at 1 site in Turkey (Türkiye).
Trial summary
Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2
- What is being tested?
- Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 30 Aug 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 an allergy detected before starting the application,
- Patients with a GKS (Glasgow Coma Scale) score of 3 and below
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: Effect of Aromatherapy Massage Applıed to Intensıve Care Patıents on Physıologıcal Parameters, Paın, Anxıety and Intensıve Care Comfort
Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients.
- Conditions
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, High Blood Pressure, Stroke, Ischemic
- Being tested
- Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level
- Keywords
- intensive care, pain, anxiety, comfort, aromatherapy massage
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, Hypertension, Ischemic Stroke, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of aromatherapy massage on vital signs, pain, anxiety and comfort levelOther
The study applied a mixture of lavender, thyme and eucalyptus oil (5 drops of lavender oil, 4 drops of thyme oil, 3 drops of eucalyptus oil and 20 ml of almond oil in 20 ml) to patients who were monitored in intensive care on high-flow and oxygen, for three days. It was conducted as a randomized controlled single-blind study to evaluate the effects of aromatherapy massage applied twice a day for a total of 30 minutes on some physiological parameters, pain, anxiety and comfort levels.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | After obtaining written and verbal permission from the families of the patients in the intervention group by signing the Informed Volunteer Consent Form, the patients were filled out the Patient Introduction Form, Patient Monitoring Form and Medication Monitoring Form by the nurses. The massage process, which was performed according to the application protocol of the aroma oil prepared for the patients (5 drops of lavender oil, 4 drops of thyme oil, 3 drops of eucalyptus oil and 20 ml of almond oil in 20 ml), was performed by the researcher by stroking the patient's back and chest, effleurage, re-effleurage, back massage. Deep caressing and stroking on the dorsal surface were performed in 6 consecutive steps. Receives: Other: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level |
| Placebo Control Group | Placebo comparator | After obtaining written and verbal approval from the families of the patients included in the placebo control group by signing the Informed Volunteer Consent Form, the patients were filled out the Patient Introduction Form, Patient Monitoring Form and Medication Monitoring Form by the nurses. According to the oil application protocol, the massage with almond oil was performed by the researcher in 6 consecutive steps by stroking the patient's back and chest, effleurage, re-effleurage, deep stroking of the back and stroking the back surface. Receives: Other: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Introduction Form
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 form the sample includes questions such as the medical diagnosis of the patients, age, gender, chronic diseases, length of stay in intensive care, use of analgesics and sedative drugs.
Measured: 2 years
Secondary outcomes (1)
Patient Follow-up Form
The patient follow-up form was created by the researcher, and the follow-up results of physiological parameters throughout the study will be included in the form. Vital signs and oxygen saturation results of the patients before and after the application will be recorded on the patient follow-up form by the nurses who collect the data of the study.
Measured: 2 years
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 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- randomized controlled single blind study
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT06295874
- Sponsor's protocol ID
- 12.10.2022/50
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Effect of Aromatherapy Massage Applıed to Intensıve Care Patıents on Physıologıcal Parameters, Paın, Anxıety and Intensıve Care Comfort
- ClinicalTrials.gov ID
- NCT06295874
- Acronym / sponsor ID
- 12.10.2022/50
- Conditions
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus, Type 2, High Blood Pressure, Stroke, Ischemic
- Keywords
- intensive care, pain, anxiety, comfort, aromatherapy massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Nilgün ErdoğanUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 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.
Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled single blind study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort levelAfter obtaining written and verbal permission from the families of the patients in the intervention group by signing the Informed Volunteer Consent Form, the patients were filled out the Patient Introduction Form, Patient Monitoring Form and Medication Monitoring Form by the nurses. The massage process, which was performed according to the application protocol of the aroma oil prepared for the patients (5 drops of lavender oil, 4 drops of thyme oil, 3 drops of eucalyptus oil and 20 ml of almond oil in 20 ml), was performed by the researcher by stroking the patient's back and chest, effleurage, re-effleurage, back massage. Deep caressing and stroking on the dorsal surface were performed in 6 consecutive steps. |
| Placebo Control Group | Placebo comparator | Other: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort levelAfter obtaining written and verbal approval from the families of the patients included in the placebo control group by signing the Informed Volunteer Consent Form, the patients were filled out the Patient Introduction Form, Patient Monitoring Form and Medication Monitoring Form by the nurses. According to the oil application protocol, the massage with almond oil was performed by the researcher in 6 consecutive steps by stroking the patient's back and chest, effleurage, re-effleurage, deep stroking of the back and stroking the back surface. |
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 (7 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 |
|---|---|---|
| Effect of aromatherapy massage on vital signs, pain, anxiety and comfort levelThe study applied a mixture of lavender, thyme and eucalyptus oil (5 drops of lavender oil, 4 drops of thyme oil, 3 drops of eucalyptus oil and 20 ml of almond oil in 20 ml) to patients who were monitored in intensive care on high-flow and oxygen, for three days. It was conducted as a randomized controlled single-blind study to evaluate the effects of aromatherapy massage applied twice a day for a total of 30 minutes on some physiological parameters, pain, anxiety and comfort levels. | Other | Intervention Group, Placebo Control Group |
Primary outcome
Patient Introduction Form
Time frame: 2 years
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 form the sample includes questions such as the medical diagnosis of the patients, age, gender, chronic diseases, length of stay in intensive care, use of analgesics and sedative drugs.
1 secondary outcome
Patient Follow-up Form
Time frame: 2 years
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 Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level in people with Respiratory Insufficiency and Pulmonary Disease, Chronic Obstructive, 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 7 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: 2 years). 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.