AromatherapyNCT05408650
Effect of Aromatherapy Massage on Sleep Quality of Post-operative Cardiothoracic Patients
A study testing Aromatherapy Massage in people with Aromatherapy, run by Mansoura University.
Trial summary
Poor sleep is common in the ICU, especially among post-operative CABG and more severely ill patients. Additionally, patients after surgery suffer from changes in physiological parameters related to ICU stressors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aromatherapy
- What is being tested?
- Aromatherapy Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult conscious patients ≥ 18 years of both gender
- ICU length of stay > 2 nights
- Physiologically or hemodynamically stable
- Free from skin problems and fractures in the area of massage
Who cannot join
- Patients who are on sedative drugs or narcotic analgesics
- Patients with an allergic history to lavender oil
- Mechanically ventilated patients
- History of sleep disorders
- History of mental disorders
About this study
Official title: Effectiveness of Aromatherapy Massage on Sleep Quality and Physiological Parameters of Post-Operative Cardiothoracic Surgery Patients
Poor sleep is common in the ICU, especially among post-operative CABG and more severely ill patients. Additionally, patients after surgery suffer from changes in physiological parameters related to ICU stressors. Pharmacological interventions for sleep improvement can both disrupt and induce sleep and have many negative side effects on intensive care patients. Therefore, this gives the green light for using complementary therapy.
Read the detailed description
Critically ill patients suffer from decreased sleep quality, especially in patients who fear death and are more severely ill. The critical care experience is stressful for patients and can result in numerous physiological and psychological effects, including physiological instability as an increase in the heart rate (HR), respiration rate (RR), and risk of cardiac dysrhythmias, leading to prolonged length of stay and subsequent complications. Sleep is affected by a variety of factors, including hospitalization and the severity of the disease. Therefore, improving the sleep quality of cardiac patients is one of the most important nursing interventions.
Sleep is a circadian state characterized by the partial or total suspension of consciousness, voluntary muscle inhibition, and relative insensitivity to stimulation. Sleep quality is an individual's general satisfaction with the sleep experience, and its main components are the quantity of sleep, sleep continuity, and a reviving feeling upon awakening. Short sleep duration is defined as less than seven hours of sleep per 24-hour period.
Sleep is a biological need for many physiological processes under primary neurobiological regulation that affects many physiological systems, so sleep is necessary for the body to repair and restore itself. At least when compared to the early morning hours, an increase in parasympathetic cardiac transition during non-rapid eye movement sleep 2 makes the nighttime a period of proportional protection from cardiovascular diseases (CVD) events. Sleep and sleep disturbances affect various components of human homeostasis, including the cardiovascular system.
Cardiovascular diseases are the most common cause of death globally, taking an estimated 17.9 million lives each year. Over three-quarters of CVD deaths take place in low and middle-income countries. In the Eastern Mediterranean Region, more than 1.3 million people died of CVD, which equals one-third of all deaths annually. Sleep disturbance is a common problem in cardiac patients. Cardiac surgery patients' perceptions of their sleep in the intensive care unit (ICU) indicate that it is inadequate.
Sleep disturbance occurs in 60 to 80% of patients in the first few days after heart surgery. One of the most common causes of sleep disturbance after coronary artery bypass graft (CABG) is subsequent alterations in physiological parameters such as systolic and diastolic blood pressure (SBP and DBP), RR, and HR.
Poor sleep quality is associated with many adverse health outcomes. Accumulating evidence proposes that insufficient sleep affects basal levels of immune, inflammatory mediators, and inflammatory reactivity to stressors. In addition, there is an increase in a person's risk of health problems and the development of many chronic.
diseases. Therefore, adequate sleep is the main requirement for physical and mental health.
Physiological changes are among the most significant symptoms and signs that need to be observed in patients with cardiothoracic diseases and surgeries. ICU patients' stress and pathological conditions cause sleep disturbances, increased oxygen consumption by the heart muscles, increased sympathetic nervous system burden, tachypnea, increased HR, and neural-hormonal responses, all of which contribute to elevated blood pressure, which complicates the healing and recovery process.
Complementary and integrative therapy (CIT) has become widely known and used in nursing. It is used alongside conventional medicine. There are several non-pharmacological methods can be helpful to improve sleep in critical patients and decrease the negative factors that affect vital signs and interrupt sleep in ICUs, including reflexology, relaxation, guided imagery, aromatherapy (AT), and massage. Complementary therapies are forms of non-pharmacological methods that are cost-effective, non-invasive, and aim to increase comfort in stressful situations.
4 Aromatherapy is a biological-based therapy in CIT. It is defined as "the art and science of utilizing naturally extracted aromatic essences from plants to balance, harmonize, and promote the health of body, mind, and spirit". Accordingly, AT depends on the use of essential oils extracted from flowers and plants. Aromatherapy affects the parasympathetic nervous system, stabilizing the patient's physiological parameters and metabolism and eventually maintaining the patient's level of relaxation.
Essential oils are used in AT to reduce certain physical and psychological manifestations and provide relaxation. Additionally, scent molecules affect the limbic system of the brain, HR, BP, RR, memory, and hormones.
Massage is one of the most commonly used techniques in CIT. It is a manipulative and body-based practice type that is often given guidance by nurses and healthcare givers to patients in their daily health care. Massage promotes relaxation by physically manipulating muscles as well as physiologically by stimulating the nervous system to regulate muscle contraction . Massage is an effective method for promoting sleep quality for ICU patients.
- Conditions
- Aromatherapy
- Being tested
- Aromatherapy Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy MassageOther
The PI will dilute pure lavender essential oil (Lavandula angustifolia) with almond oil at a dilution rate of 2.5% and apply it to the hands and feet of the patient.
- The massage technique including effleurage, petrissage, friction and lymphatic drainage on hands and feet will be adapted from Salvo, (2015) and Youssef and Hassan, (2017).
- The massage will be applied to the patient's hands and feet while the patient in semi-fowler's position.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy massage group | Experimental | The massage will be applied to the patient's hands and feet while the patient in semi-fowler's position. Receives: Other: Aromatherapy Massage |
| control group | No intervention | The patients will receive the routine care of the ICU (such as decreased movements of the staff and soft light in the area at night). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep or Level of sleep as assessed by Richards-Campbell Sleep Questionnaire
Sleep quality will be assessed by Richards-Campbell Sleep Questionnaire which covers five aspects of sleep: depth, latency, frequency of awakening, percentage of time awake, and sleep quality.
A total score is obtained by summing each score out of 100, then dividing the total by five and ranking the total score into three categories as follows:
- A score from 0 mm to 33 mm indicates poor sleep
- A score of between 33 mm to 66 mm indicates normal sleep
- A score of over 66 mm indicates very good sleep
Measured: 2 days
Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.
Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AromatherapyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ali Saad Elhusseini, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408650
- Sponsor's protocol ID
- P.0237
- Status last verified
- Jun 2022
- First submitted
- 28 May 2022
- Last updated
- 7 Jun 2022
- 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 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aromatherapy Massage on Sleep Quality and Physiological Parameters of Post-Operative Cardiothoracic Surgery Patients
- ClinicalTrials.gov ID
- NCT05408650
- Acronym / sponsor ID
- P.0237
- Conditions
- Aromatherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 7 Jun 2022 (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.
Poor sleep is common in the ICU, especially among post-operative CABG and more severely ill patients. Additionally, patients after surgery suffer from changes in physiological parameters related to ICU stressors. Pharmacological interventions for sleep improvement can both disrupt and induce sleep and have many negative side effects on intensive care patients. Therefore, this gives the green light for using complementary therapy.
Detailed description
Critically ill patients suffer from decreased sleep quality, especially in patients who fear death and are more severely ill. The critical care experience is stressful for patients and can result in numerous physiological and psychological effects, including physiological instability as an increase in the heart rate (HR), respiration rate (RR), and risk of cardiac dysrhythmias, leading to prolonged length of stay and subsequent complications. Sleep is affected by a variety of factors, including hospitalization and the severity of the disease. Therefore, improving the sleep quality of cardiac patients is one of the most important nursing interventions.
Sleep is a circadian state characterized by the partial or total suspension of consciousness, voluntary muscle inhibition, and relative insensitivity to stimulation. Sleep quality is an individual's general satisfaction with the sleep experience, and its main components are the quantity of sleep, sleep continuity, and a reviving feeling upon awakening. Short sleep duration is defined as less than seven hours of sleep per 24-hour period.
Sleep is a biological need for many physiological processes under primary neurobiological regulation that affects many physiological systems, so sleep is necessary for the body to repair and restore itself. At least when compared to the early morning hours, an increase in parasympathetic cardiac transition during non-rapid eye movement sleep 2 makes the nighttime a period of proportional protection from cardiovascular diseases (CVD) events. Sleep and sleep disturbances affect various components of human homeostasis, including the cardiovascular system.
Cardiovascular diseases are the most common cause of death globally, taking an estimated 17.9 million lives each year. Over three-quarters of CVD deaths take place in low and middle-income countries. In the Eastern Mediterranean Region, more than 1.3 million people died of CVD, which equals one-third of all deaths annually. Sleep disturbance is a common problem in cardiac patients. Cardiac surgery patients' perceptions of their sleep in the intensive care unit (ICU) indicate that it is inadequate.
Sleep disturbance occurs in 60 to 80% of patients in the first few days after heart surgery. One of the most common causes of sleep disturbance after coronary artery bypass graft (CABG) is subsequent alterations in physiological parameters such as systolic and diastolic blood pressure (SBP and DBP), RR, and HR.
Poor sleep quality is associated with many adverse health outcomes. Accumulating evidence proposes that insufficient sleep affects basal levels of immune, inflammatory mediators, and inflammatory reactivity to stressors. In addition, there is an increase in a person's risk of health problems and the development of many chronic.
diseases. Therefore, adequate sleep is the main requirement for physical and mental health.
Physiological changes are among the most significant symptoms and signs that need to be observed in patients with cardiothoracic diseases and surgeries. ICU patients' stress and pathological conditions cause sleep disturbances, increased oxygen consumption by the heart muscles, increased sympathetic nervous system burden, tachypnea, increased HR, and neural-hormonal responses, all of which contribute to elevated blood pressure, which complicates the healing and recovery process.
Complementary and integrative therapy (CIT) has become widely known and used in nursing. It is used alongside conventional medicine. There are several non-pharmacological methods can be helpful to improve sleep in critical patients and decrease the negative factors that affect vital signs and interrupt sleep in ICUs, including reflexology, relaxation, guided imagery, aromatherapy (AT), and massage. Complementary therapies are forms of non-pharmacological methods that are cost-effective, non-invasive, and aim to increase comfort in stressful situations.
4 Aromatherapy is a biological-based therapy in CIT. It is defined as "the art and science of utilizing naturally extracted aromatic essences from plants to balance, harmonize, and promote the health of body, mind, and spirit". Accordingly, AT depends on the use of essential oils extracted from flowers and plants. Aromatherapy affects the parasympathetic nervous system, stabilizing the patient's physiological parameters and metabolism and eventually maintaining the patient's level of relaxation.
Essential oils are used in AT to reduce certain physical and psychological manifestations and provide relaxation. Additionally, scent molecules affect the limbic system of the brain, HR, BP, RR, memory, and hormones.
Massage is one of the most commonly used techniques in CIT. It is a manipulative and body-based practice type that is often given guidance by nurses and healthcare givers to patients in their daily health care. Massage promotes relaxation by physically manipulating muscles as well as physiologically by stimulating the nervous system to regulate muscle contraction . Massage is an effective method for promoting sleep quality for ICU patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy massage group | Experimental | Other: Aromatherapy MassageThe massage will be applied to the patient's hands and feet while the patient in semi-fowler's position. |
| control group | No intervention | –The patients will receive the routine care of the ICU (such as decreased movements of the staff and soft light in the area at night). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult conscious patients ≥ 18 years of both gender
- ICU length of stay > 2 nights
- Physiologically or hemodynamically stable
- Free from skin problems and fractures in the area of massage
Key exclusion criteria (5 listed)
- Patients who are on sedative drugs or narcotic analgesics
- Patients with an allergic history to lavender oil
- Mechanically ventilated patients
- History of sleep disorders
- History of mental disorders
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 |
|---|---|---|
| Aromatherapy MassageThe PI will dilute pure lavender essential oil (Lavandula angustifolia) with almond oil at a dilution rate of 2.5% and apply it to the hands and feet of the patient. * The massage technique including effleurage, petrissage, friction and lymphatic drainage on hands and feet will be adapted from Salvo, (2015) and Youssef and Hassan, (2017). * The massage will be applied to the patient's hands and feet while the patient in semi-fowler's position. | Other | Aromatherapy massage group |
Primary outcome
Quality of sleep or Level of sleep as assessed by Richards-Campbell Sleep Questionnaire
Time frame: 2 days
Sleep quality will be assessed by Richards-Campbell Sleep Questionnaire which covers five aspects of sleep: depth, latency, frequency of awakening, percentage of time awake, and sleep quality. A total score is obtained by summing each score out of 100, then dividing the total by five and ranking the total score into three categories as follows: * A score from 0 mm to 33 mm indicates poor sleep * A score of between 33 mm to 66 mm indicates normal sleep * A score of over 66 mm indicates very good sleep
Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.
Time frame: 2 days
Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy Massage in people with Aromatherapy, run by Mansoura University.
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 4 inclusion and 5 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Quality of sleep or Level of sleep as assessed by Richards-Campbell Sleep Questionnaire (time frame: 2 days). 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 7 Jun 2022.