The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort

NCT ID: NCT06295874

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2024-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nilgün Erdoğan

OTHER

Sponsor Role: lead

Responsible Party

Nilgün Erdoğan

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ömer Halisdemir University Training and Research Hospital

Niğde, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

nilgun erdogan, researcher

Role: primary

nilgunerdogan37@gmail.com

5312599220

Other Identifiers

12.10.2022/50

Identifier Type: -

Identifier Source: org_study_id