The Effect of Aromatherapy on the Insulin Injection Pain

February 22, 2021 updated by: Hatice Demirağ, Karadeniz Technical University

The Effect of Topically Administered Lavender Aromatherapy on the Pain of Insulin Injection in Diabetic Patients: A Double-Blind Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61800
        • Karadeniz Tecnical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Other: 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.
PLACEBO_COMPARATOR: 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.
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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Level before insulin injection
Time Frame: day 1
It was evaluated between the Verbal Category Scale (VCS) pain scores of the patients in the topical lavender oil group before insulin injection. Verbal Category Scale is based on the patient's choice of the most appropriate word to identify his/her pain. Accordingly, the patient was asked to rate his/her pain between 0-4 as 0; no pain, 1: mild pain, 2: severe pain, 3: very severe pain, 4: unbearable pain.
day 1
Pain Level before insulin injection
Time Frame: day 1
It was evaluated between the Visual Analogue Scale (VAS) pain scores of the patients in the topical lavender oil group before insulin injection. Visual Analogue Scale is used to digitalize the pain level that cannot be measured numerically. A line with a length of 100 mm has the words "no pain" at one end and "the most unbearable pain" on the other. The patient indicates his/her pain by choosing the most appropriate place on the line. Then, the level of pain experienced by the patient is determined by using a scale with scores between 0-10. According to this scoring system, less than 3 points indicate mild pain, 3-6 points indicate moderate pain, and more than 6 points indicate severe pain.
day 1
Pain Level after insulin injection
Time Frame: day 1
It was evaluated between the VCS pain scores of the patients in the topical lavender oil group during insulin injection. Verbal Category Scale is based on the patient's choice of the most appropriate word to identify his/her pain. Accordingly, the patient was asked to rate his/her pain between 0-4 as 0; no pain, 1: mild pain, 2: severe pain, 3: very severe pain, 4: unbearable pain.
day 1
Pain Level after insulin injection
Time Frame: day 1
It was evaluated between the VAS pain scores of the patients in the topical lavender oil group during insulin injection. Visual Analogue Scale is used to digitalize the pain level that cannot be measured numerically. A line with a length of 100 mm has the words "no pain" at one end and "the most unbearable pain" on the other. The patient indicates his/her pain by choosing the most appropriate place on the line. Then, the level of pain experienced by the patient is determined by using a scale with scores between 0-10. According to this scoring system, less than 3 points indicate mild pain, 3-6 points indicate moderate pain, and more than 6 points indicate severe pain.
day 1
Blood glucose before insulin injection
Time Frame: day 1
Before the administration blood glucose (mg/dl) of all patients (topical lavender oil, placebo, and control groups) were measured. Blood glucose measurement is done with a blood glucose meter (glucometer) and a measuring stick (strip). Fasting blood glucose 70-125 mg / dl was considered normal.
day 1
Oxygen Saturation (SPO2) before insulin injection
Time Frame: day 1
Before the administration oxygen saturation level (SPO2)(%) of all patients (topical lavender oil, placebo, and control groups) were measured. The researcher measured the oxygen saturation in subcutaneous arterial blood with a "Pulse oximeter" device that is reliable, easy to use, does not require calibration and does not cause pain to the patient in its application. Normal value of oxygen saturation (SpO2) (%) was accepted as 96-98%. After placing a probe in the periphery (on the patient's finger) by the investigator, the signal received from the periphery and the value on the image screen (monitor) where the pulse wave sample was projected was recorded as oxygen saturation.
day 1
Systolic and Diastolic Blood Pressure before insulin injection
Time Frame: day 1
Before the administration blood pressure (mm/Hg) of all patients (topical lavender oil, placebo, and control groups) were measured. Blood Pressure Measurement was performed using a conventional cuffed sphygmomanometer that can measure systolic and diastolic blood pressure, whose reliability was approved according to international standards and calibrated by the company in technical laboratories for certain periods. The cuff of the sphygmomanometer will be inflated to 20 mm / Hg above the systolic pressure by tying it to cover 2/3 of the arm, and the measurement will be carried out by the researcher.
day 1
Pulse rate before insulin injection
Time Frame: day 1
Before the administration pulse rate (min) of all patients (topical lavender oil, placebo, and control groups) were measured. The pulse was obtained by the investigator palpating the superficial arteries (by touching them with the hand) and counting the beats felt for one minute. 60 to 100 beats per minute was considered normal for an adult.
day 1
Respiration rate before insulin injection
Time Frame: day 1
Before the administration Respiration rate (min) of all patients (topical lavender oil, placebo, and control groups) were measured. Respiration rate was measured by the number of diaphragm movements per minute. For an adult at rest, 12 to 20 per minute was considered normal for respiratory rate.
day 1
Blood glucose after insulin injection
Time Frame: day 1
After the administration blood glucose (mg/dl) of all patients (topical lavender oil, placebo, and control groups) were measured. Blood glucose measurement is done with a blood glucose meter (glucometer) and a measuring stick (strip). Fasting blood glucose 140-199 mg / dl was considered normal.
day 1
Oxygen Saturation (SPO2) after insulin injection
Time Frame: day 1
After the administration oxygen saturation level (SPO2)(%) of all patients (topical lavender oil, placebo, and control groups) were measured. The researcher measured the oxygen saturation in subcutaneous arterial blood with a "Pulse oximeter" device that is reliable, easy to use, does not require calibration and does not cause pain to the patient in its application. Normal value of oxygen saturation (SpO2) (%) was accepted as 96-98%. After placing a probe in the periphery (on the patient's finger) by the investigator, the signal received from the periphery and the value on the image screen (monitor) where the pulse wave sample was projected was recorded as oxygen saturation.
day 1
Systolic and Diastolic Blood Pressure after insulin injection
Time Frame: day 1
After the administration blood pressure (mm/Hg) of all patients (topical lavender oil, placebo, and control groups) were measured. Blood Pressure Measurement was performed using a conventional cuffed sphygmomanometer that can measure systolic and diastolic blood pressure, whose reliability was approved according to international standards and calibrated by the company in technical laboratories for certain periods. The cuff of the sphygmomanometer will be inflated to 20 mm / Hg above the systolic pressure by tying it to cover 2/3 of the arm, and the measurement will be carried out by the researcher.
day 1
Pulse rate after insulin injection
Time Frame: day 1
After the administration pulse rate (min) of all patients (topical lavender oil, placebo, and control groups) were measured. The pulse was obtained by the investigator palpating the superficial arteries (by touching them with the hand) and counting the beats felt for one minute. 60 to 100 beats per minute was considered normal for an adult.
day 1
Respiration rate after insulin injection
Time Frame: day 1
After the administration Respiration rate (min) of all patients (topical lavender oil, placebo, and control groups) were measured. Respiration rate was measured by the number of diaphragm movements per minute. For an adult at rest, 12 to 20 per minute was considered normal for respiratory rate.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCT1004201704062014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I'll decide later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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