Clinical trial NCT04767737: The Effect of Aromatherapy on the Insulin Injection Pain
Official title: The Effect of Topically Administered Lavender Aromatherapy on the Pain of Insulin Injection in Diabetic Patients: A Double-Blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Aromatherapy
Subcutaneous Injections
Keywords: Pain
aromatherapy
topical lavender oil
subcutaneous injections
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample was determined as 159 (53 for each group) patients for three groups (lavender oil group, placebo group, control group) by using the power analysis method (G\*Power 3.1.9.6 program), with the margin of error α=0.05, 0.25 medium effect size, and 0.80 (80%) target strength of the test. However, 7 patients who met the study inclusion criteria were added to each group (60 in the lavender oil group, 60 in the placebo group, 60 in the control group) in case some of the participants quit the study for any reason (Figure 1). While the patients were randomized, different application groups (topical lavender oil, placebo, control group) were determined by lot in different months (May, June, and July) to minimize the possibility of being affected by each other.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Needle phobia occurs in more than half of diabetic patients due to the pain caused by frequent insulin injection. Therefore, this study evaluated the effect of topically administered lavender aromatherapy on the pain of insulin injection in diabetic patients.

Detailed description: Diabetes Mellitus (DM) is a serious chronic disease that negatively affects the quality of life. To control the course of the disease and to reduce its complications, insulin treatment is planned for the whole life of Type 1 diabetic patients, and frequently for approximately 40% of Type 2 diabetic patients. Frequent or incorrect administration of insulin injections may lead to the development of complications such as regional pain, ecchymosis, or hematoma on the injection site. It is emphasized that the pain caused by repeated insulin injections negatively affects the psychological well-being of the individuals as well as their physical comfort. Pain control is one of the main tasks of nurses. By alleviating pain, the patient's acceptance of treatment increases, and thus the quality of life improves. In the literature, lavender is reported to have the ability to heal burns and insect bites as well as analgesic, wound healing, antibacterial, antifungal, sedative, and antidepressant effects. The main components of lavender, such as lavender and linalyl acetate and linalool, are also recommended as topical analgesics in animal models. Whatever the cause, acute pain is a serious problem for individuals with chronic illnesses. Therefore, this study evaluated the effect of topically administered lavender aromatherapy on the pain of insulin injection in diabetic patients.

Eligibility criteria: Inclusion Criteria:

* being 18 years of age or older,
* having Type-1 DM or Type-2 DM disease,
* being conscious and communicating, not having mental and cognitive impairment,
* not having eczema and fragrance allergy to lavender,
* not having an alcohol or narcotic addiction,
* not having a head injury or convulsion history,
* not having a diabetes-related neuropathy, and
* if the patient took sedatives or analgesics, at least 6 hours would pass,

Exclusion Criteria:

* having a history of addiction or diagnosed psychological disorders,
* having an unstable hemodynamic status,
* having skin disease symptoms such as wounds and eczema at the insulin injection site and,
* having an allergy to lavender.

Primary outcomes:
measure: Pain Level before insulin injection
timeFrame: day 1
measure: Pain Level before insulin injection
timeFrame: day 1
measure: Pain Level after insulin injection
timeFrame: day 1
measure: Pain Level after insulin injection
timeFrame: day 1
measure: Blood glucose before insulin injection
timeFrame: day 1
measure: Oxygen Saturation (SPO2) before insulin injection
timeFrame: day 1
measure: Systolic and Diastolic Blood Pressure before insulin injection
timeFrame: day 1
measure: Pulse rate before insulin injection
timeFrame: day 1
measure: Respiration rate before insulin injection
timeFrame: day 1
measure: Blood glucose after insulin injection
timeFrame: day 1
measure: Oxygen Saturation (SPO2) after insulin injection
timeFrame: day 1
measure: Systolic and Diastolic Blood Pressure after insulin injection
timeFrame: day 1
measure: Pulse rate after insulin injection
timeFrame: day 1
measure: Respiration rate after insulin injection
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical University
Study officials:
References: