The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort

NCT06295874 | Recruiting DMC

• 1 other identifier: 12.10.2022/50
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

intensive care; pain; anxiety; comfort; aromatherapy massage

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Patient Follow-up Form

  2 years

Other Outcomes (4)

• Drug Monitoring Form

  2 years

• Visual Pain Scale

  2 years

• Face Anxiety Scale

  2 years

Study Arms (2)

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.

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.

Other: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level

Interventions

Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level OTHER

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.

Intervention Group; Placebo Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nilgün Erdoğan: lead

Study Sites (1)

Ömer Halisdemir University Training and Research Hospital

Niğde, 51100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus, Type 2; Hypertension; Ischemic Stroke; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled single blind study

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: March 6, 2024
• Study Start: January 5, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Locations

TU (1)