The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Stroke, Ischemic; High Blood Pressure
• Intervention / Treatment: Other: Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level

• Study Type: Interventional
• Enrollment (Estimated): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Nigde, Turkey, 51100
    • Recruiting
    • Ömer Halisdemir University Training and Research Hospital
    • Contact: nilgun erdogan, researcher; Phone Number: 5312599220; Email: nilgunerdogan37@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; 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; 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.
Placebo Comparator: Placebo Control Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Monitoring Form	The medication monitoring form was created by the researcher, and the form will include the dosage of the analgesic and sedative medications the patient received in the intensive care unit during the study. The medication monitoring form will be recorded with the dosage taken before and after the application by the nurses who collect the data of the study.	2 years
Visual Pain Scale	The scale developed by Price et al. (1983) is a scale in which patients evaluate their pain between 1 and 10. VAS is a scale used to describe varying degrees of pain experienced by a patient. It is evaluated at varying degrees between "0", "no pain" and "10", "severe pain".	2 years
Face Anxiety Scale	The Facial Anxiety Scale was developed to determine the presence and level of patient anxiety based on facial expressions. The Facial Anxiety Scale, developed by McKinley and colleagues (2003), has been used in several studies for patients on invasive and non-invasive ventilation. Each item in the anxiety subscale is rated between 1 and 5 points, ranging from "not at all" to "extremely".	2 years
Comfort Rating Scale	Numerik Konfor Derecelendirme Ölçeği, Kolcaba (2003) tarafından geliştirilen (Kolcaba, 2003), 0'dan 10'a kadar değişen derecelerde kullanılan bir analog skaladır. Rahatlık 0-10 arasında derecelendirilmektedir; 0, "hiç konfor yok", 10 "en yüksek konforu" göstermektedir. Hastanın durumuna göre değerlendirilmesi yapılmaktadır	2 years

Collaborators and Investigators

• Sponsor: Nilgün Erdoğan

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pain; comfort; anxiety; intensive care; aromatherapy massage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Lung Diseases, Obstructive; Stroke; Chronic Disease; Hypertension; Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive; Ischemic Stroke; Respiratory Insufficiency
• Other Study ID Numbers: 12.10.2022/50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No