The Effect of Aromatherapy on the Insulin Injection Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Aromatherapy Subcutaneous Injections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Since this study was a double-blind randomized controlled study, no information about the drug (topical lavender oil, topical water) was given to the nurse (researcher) who gave insulin injection, and the patient to reduce bias. The drug to be used was applied in spray bottles without any labels.

Study Groups

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Topical lavender oil group

Before the administration, pain level, blood pressure, respiratory rate, pulse rate, oxygen saturation level (SPO2), and blood glucose of all patients (topical lavender oil, placebo, and control groups) were measured, and then, 3 puffs (0.3 ml) of 100% lavender (Lavandula Angustifolia) essential oil to the topical lavender oil group were sprayed on the arms of the patients. 5 minutes later, the insulin injection site was wiped with 10% povidone-iodine (baticonol) in all patients, and the injection was given. During the administration of the insülin, the pain levels of the patients were measured again. After giving the injection, blood pressure, respiratory rate, pulse rate, oxygen saturation level, and blood glucose of the patients were also measured again.

Group Type EXPERIMENTAL

Topically Administered Lavender Aromatherapy

Intervention Type OTHER

3 puffs (0.3 ml) of 100% lavender (Lavandula Angustifolia) essential oil to the topical lavender oil group were sprayed on the arms of the patients.

Placebo group

Before the administration, pain level, blood pressure, respiratory rate, pulse rate, oxygen saturation level (SPO2), and blood glucose of all patients (topical lavender oil, placebo, and control groups) were measured, and then, 3 puffs (0.3 ml) of topical distilled water to the placebo group were sprayed on the arms of the patients. No application was applied to the control group. 5 minutes later, the insulin injection site was wiped with 10% povidone-iodine (baticonol) in all patients, and the injection was given. During the administration of the insülin, the pain levels of the patients were measured again. After giving the injection, blood pressure, respiratory rate, pulse rate, oxygen saturation level, and blood glucose of the patients were also measured again.

Group Type PLACEBO_COMPARATOR

Topically Administered Water

Intervention Type OTHER

3 puffs (0.3 ml) of topical distilled water to the placebo group were sprayed on the arms of the patients.

Control groups

Before the administration, pain level, blood pressure, respiratory rate, pulse rate, oxygen saturation level (SPO2), and blood glucose of all patients (topical lavender oil, placebo, and control groups) were measured.No application was applied to the control group. 5 minutes later, the insulin injection site was wiped with 10% povidone-iodine (baticonol) in all patients, and the injection was given. During the administration of the insülin, the pain levels of the patients were measured again. After giving the injection, blood pressure, respiratory rate, pulse rate, oxygen saturation level, and blood glucose of the patients were also measured again.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Topically Administered Lavender Aromatherapy

3 puffs (0.3 ml) of 100% lavender (Lavandula Angustifolia) essential oil to the topical lavender oil group were sprayed on the arms of the patients.

Intervention Type OTHER

Topically Administered Water

3 puffs (0.3 ml) of topical distilled water to the placebo group were sprayed on the arms of the patients.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes