The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Aromatherapy Massage Applıed to Intensıve Care Patıents on Physıologıcal Parameters, Paın, Anxıety and Intensıve Care Comfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295874
• Other study ID #: 12.10.2022/50
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• High Blood Pressure
• Hypertension
• Ischemic Stroke
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ömer Halisdemir University Training and Research Hospital	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nilgün Erdogan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Comfort Rating Scale	Numerik Konfor Derecelendirme Ölçegi, Kolcaba (2003) tarafindan gelistirilen (Kolcaba, 2003), 0'dan 10'a kadar degisen derecelerde kullanilan bir analog skaladir. Rahatlik 0-10 arasinda derecelendirilmektedir; 0, "hiç konfor yok", 10 "en yüksek konforu" göstermektedir. Hastanin durumuna göre degerlendirilmesi yapilmaktadir	2 years
Primary	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	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